Saffron

Last content change Mar 17, 2020checked dailysee data sync status

This product has been discontinued

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Active ingredient: Saffron 3 [hp_X]
Other brand names: Crocus Sativus (by Boiron)
Crocus Sativus (by Boiron)
Crocus Sativus (by Hahnemann Laboratories, Inc.)
Dysmenorrhea Headache (by Natural Health Supply)
View full label-group details →
Dosage form: Pellet
Route: Oral
Prescription status: Homeopathic
Marketed in the U.S.: Since 2015
Label revision date: March 17, 2020
Manufacturer Document: Prescribing information, PDF file

Active ingredient: Saffron 3 [hp_X]
Other brand names: Crocus Sativus (by Boiron)
Crocus Sativus (by Boiron)
Crocus Sativus (by Hahnemann Laboratories, Inc.)
Dysmenorrhea Headache (by Natural Health Supply)
View full label-group details →
Dosage form: Pellet
Route: Oral
Prescription status: Homeopathic
CSA schedule: Not a scheduled drug
Marketed in the U.S.: Since 2015
Label revision date: March 17, 2020
Manufacturer: Rxhomeo Private Limited d. b. a. Rxhomeo, Inc
NDC root: 15631-0158
Manufacturer Document: Prescribing information, PDF file

Packaging Info (6 NDCs)

Packaging & NDC Codes (6)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

You may be wondering about a medication that is used for specific conditions as directed by your physician. This drug is designed to help manage certain health issues effectively, although the exact conditions it treats are not specified here.

It's important to follow your doctor's guidance on how to use this medication to ensure you receive the best possible care. If you have any questions about its purpose or how it can help you, don't hesitate to reach out to your healthcare provider for more information.

Uses

You may be prescribed this medication for a specific condition as determined by your doctor. It's important to follow their guidance on how to use it effectively.

This medication does not have any known harmful effects on developing babies (teratogenic effects) or any other non-harmful effects mentioned. Always consult your healthcare provider if you have questions about its use or effects.

Dosage and Administration

You should take this medication by mouth, either 4 or 6 pellets, three times a day. If you are a child aged 2 years or older, you will need to take half of the adult dose. It's important to follow your physician's advice regarding the exact dosage and frequency, as they may suggest adjustments based on your specific needs.

Make sure to take the medication consistently at the same times each day to help maintain its effectiveness. If you have any questions or concerns about how to take this medication, don’t hesitate to reach out to your healthcare provider for guidance.

Warnings and Precautions

This product is intended for short-term use to help with self-limiting conditions, meaning it should only be used for issues that typically resolve on their own. If your symptoms do not improve within four days or if they worsen, it’s important to stop using the product and consult a healthcare professional for further guidance.

If you are pregnant or nursing, please seek advice from a healthcare provider before using this medication. Always keep this and all medications out of reach of children to prevent accidental ingestion. Additionally, do not use the product if the cap seal is broken or missing, and remember to close the cap tightly after each use to maintain its effectiveness.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dark place. This helps maintain its effectiveness and prevents any degradation. When handling the product, be sure to follow any specific instructions provided to ensure safe use. Proper storage and careful handling are key to maximizing the benefits of your device.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What conditions can this product be used for?

This product is indicated for the condition listed above or as directed by your physician.

What is the recommended dosage for adults?

Adults should take 4 or 6 pellets by mouth, three times daily or as suggested by your physician.

What is the dosage for children?

Children 2 years and older should take half the adult dose.

How should this product be taken?

This product should be taken by mouth, three times daily or as suggested by your physician.

What should I do if my symptoms do not improve?

If your symptoms do not improve in 4 days or worsen, discontinue use and seek assistance from a health professional.

Is this product safe to use during pregnancy or while nursing?

If you are pregnant or nursing, seek professional advice before taking this product.

How should I store this medication?

Store this product in a cool, dark place and keep it out of reach of children.

What should I do if the capseal is broken or missing?

Do not use the product if the capseal is broken or missing.

What should I do after using this product?

Close the cap tightly after use.

Are there any teratogenic or nonteratogenic effects associated with this product?

No teratogenic (causing malformations) or nonteratogenic effects are mentioned.

Packaging Info

This section summarizes the homeopathic presentations of Crocus Sativus. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Crocus Sativus.

	100 in package 100 items total	Pellet	3 [hp_X]
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Saffron 3 [hp_X] Inactive ingredients sucrose
	200 in package 200 items total	Pellet	3 [hp_X]
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Saffron 3 [hp_X] Inactive ingredients sucrose
	400 in package 400 items total	Pellet	3 [hp_X]
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Saffron 3 [hp_X] Inactive ingredients sucrose
	750 in package 750 items total	Pellet	3 [hp_X]
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Saffron 3 [hp_X] Inactive ingredients sucrose
	2500 in package 2500 items total	Pellet	3 [hp_X]
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Saffron 3 [hp_X] Inactive ingredients sucrose
	12500 in package 12500 items total	Pellet	3 [hp_X]
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Saffron 3 [hp_X] Inactive ingredients sucrose

Manufacturer Insert (PDF)

This file includes usage instructions and other product details provided by the manufacturer. This is not an FDA-approved drug.

View manufacturer document (PDF)

Description

Description:

Crocus Sativus HPUS 3X and higher is the active ingredient in this human over-the-counter drug, with a strength of saffron at 3 hp_X. The product is administered orally and contains sucrose as an inactive ingredient. It is packaged under multiple item codes, including NDC:15631-0158-0100, NDC:15631-0158-1200, NDC:15631-0158-2400, NDC:15631-0158-3750, NDC:15631-0158-2500, and NDC:15631-0158-12500, all classified as not combination products. The marketing category is unapproved homeopathic, with a marketing start date of September 7, 2015. The labeler for this product is Rxhomeo Private Limited, operating as Rxhomeo, Inc (NPI: 650833994).

Packaging & NDC

This section summarizes the homeopathic presentations of Crocus Sativus. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Crocus Sativus.

	100 in package 100 items total	Pellet	3 [hp_X]
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Saffron 3 [hp_X] Inactive ingredients sucrose
	200 in package 200 items total	Pellet	3 [hp_X]
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Saffron 3 [hp_X] Inactive ingredients sucrose
	400 in package 400 items total	Pellet	3 [hp_X]
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Saffron 3 [hp_X] Inactive ingredients sucrose
	750 in package 750 items total	Pellet	3 [hp_X]
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Saffron 3 [hp_X] Inactive ingredients sucrose
	2500 in package 2500 items total	Pellet	3 [hp_X]
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Saffron 3 [hp_X] Inactive ingredients sucrose
	12500 in package 12500 items total	Pellet	3 [hp_X]
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC: NSDE file: February 16, 2026 → status: Not marketed Type Type 0: Not a Combination Product Active ingredients Saffron 3 [hp_X] Inactive ingredients sucrose

Manufacturer Insert (PDF)

This is the product document submitted by Rxhomeo Private Limited d. b. a. Rxhomeo, Inc for Crocus Sativus. It includes information on ingredients, suggested use, and labeling language. This product is not FDA-approved.

View product insert (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the manufacturer-supplied FDA Structured Product Label (DailyMed) for Crocus Sativus, retrieved February 18, 2026 by a validated AI data-extraction workflow.

All dosage forms and strengths provided by the manufacturer are listed in the Packaging & NDC Codes section above.

Homeopathic drug products are not reviewed by FDA for safety or effectiveness; information is reproduced without modification.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update: February 18, 2026

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.