76472-7009 NDC - COMFORT DOWN THERE (AESCULUS HIPPOCASTANUM 5C, ALOE 5C, BERBERIS VULGARIS 3C, CAPSICUM ANNUUM 5C, CARDUUS MARIANUS 3C, NUX VOMICA 5C, PULSATILLA 9C)

Drug Information

  • Product NDC: 76472-7009
  • Proprietary Name: Comfort Down There
  • Non Proprietary Name: Aesculus hippocastanum 5C, Aloe 5C, Berberis vulgaris 3C, Capsicum Annuum 5C, Carduus marianus 3C, Nux vomica 5C, Pulsatilla 9C
  • Active Ingredient(s): .1 mg/100mL CAPSICUM ANNUUM WHOLE; .1 mg/100mL STRYCHNOS NUX-VOMICA SEED; .1 mg/100mL ALOE FEROX WHOLE; .1 mg/100mL AESCULUS HIPPOCASTANUM WHOLE; .1 mg/100mL BERBERIS VULGARIS ROOT BARK; .1 mg/100mL PULSATILLA VULGARIS WHOLE; .1 mg/100mL SILYBUM MARIANUM SEED
  • Administration Route(s): BUCCAL
  • Dosage Form(s): SPRAY
  • Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Seed Storage Proteins [CS]

Labeler Information

Field Name Field Value
Labeler Name: SEVENE USA
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:8/19/2026

Package Information

No. Package Code Package Description Billing Unit
176472-7009-21 BOTTLE, SPRAY in 1 BOX (76472-7009-2) / 30 mL in 1 BOTTLE, SPRAY (76472-7009-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC76472-7009The 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 NAMEComfort Down ThereThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXHemorrhoidsA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEAesculus hippocastanum 5C, Aloe 5C, Berberis vulgaris 3C, Capsicum Annuum 5C, Carduus marianus 3C, Nux vomica 5C, Pulsatilla 9CThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESPRAYThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEBUCCALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/19/2026This 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 NAMESEVENE USAName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECAPSICUM ANNUUM WHOLE; STRYCHNOS NUX-VOMICA SEED; ALOE FEROX WHOLE; AESCULUS HIPPOCASTANUM WHOLE; BERBERIS VULGARIS ROOT BARK; PULSATILLA VULGARIS WHOLE; SILYBUM MARIANUM SEEDAn 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 STRENGTH.1; .1; .1; .1; .1; .1; .1 
ACTIVE INGRED UNITmg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS] 

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This page was last updated on: 9/11/2026