71971-9042 NDC - REAL RELIEF NATURAL WELLNESS CALMING SYRUP (ASAFOETIDA, STRYCHNOS IGNATII SEED (IGNATIA AMARA), VALERIANA OFFICINALIS WHOLE (VALERIANA OFFICINALIS), OAT BRAN (AVENA SATIVA), SILVER NITRATE (ARGENTUM NITRICUM), HYOSCYAMUS NIGER, PAEONIA OFFICINALIS ROOT (PAEONIA OFFICINALIS), DATURA STRAMONIUM, ANAMIRTA COCCULUS WHOLE (COCCULUS INDICUS))

Drug Information

  • Product NDC: 71971-9042
  • Proprietary Name: Real Relief Natural Wellness Calming Syrup
  • Non Proprietary Name: asafoetida, strychnos ignatii seed (ignatia amara), valeriana officinalis whole (valeriana officinalis), oat bran (avena sativa), silver nitrate (argentum nitricum), hyoscyamus niger, paeonia officinalis root (paeonia officinalis), datura stramonium, anamirta cocculus whole (cocculus indicus)
  • Active Ingredient(s): 8 [hp_X]/100mL ANAMIRTA COCCULUS WHOLE; 8 [hp_X]/100mL DATURA STRAMONIUM; 8 [hp_X]/100mL FERULA ASSA-FOETIDA RESIN; 8 [hp_X]/100mL HYOSCYAMUS NIGER; 8 [hp_X]/100mL OAT BRAN; 8 [hp_X]/100mL PAEONIA OFFICINALIS ROOT; 8 [hp_X]/100mL SILVER NITRATE; 8 [hp_X]/100mL STRYCHNOS IGNATII SEED; 8 [hp_X]/100mL VALERIANA OFFICINALIS WHOLE
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID

Labeler Information

Field Name Field Value
Labeler Name: Homeolab International (Canada) inc
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:9/1/2022

Package Information

No. Package Code Package Description Billing Unit
171971-9042-51 BOTTLE in 1 CARTON (71971-9042-5) / 100 mL in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC71971-9042The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEReal Relief Natural Wellness Calming SyrupThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEasafoetida, strychnos ignatii seed (ignatia amara), valeriana officinalis whole (valeriana officinalis), oat bran (avena sativa), silver nitrate (argentum nitricum), hyoscyamus niger, paeonia officinalis root (paeonia officinalis), datura stramonium, anamirta cocculus whole (cocculus indicus)The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/1/2022This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEHomeolab International (Canada) incName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEANAMIRTA COCCULUS WHOLE; DATURA STRAMONIUM; FERULA ASSA-FOETIDA RESIN; HYOSCYAMUS NIGER; OAT BRAN; PAEONIA OFFICINALIS ROOT; SILVER NITRATE; STRYCHNOS IGNATII SEED; VALERIANA OFFICINALIS WHOLEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH8; 8; 8; 8; 8; 8; 8; 8; 8 
ACTIVE INGRED UNIT[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 

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This page was last updated on: 11/21/2025

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