69396-020 NDC - HEMORRHOIDALOINTMENT ()

Drug Information

  • Product NDC: 69396-020
  • Proprietary Name: HemorrhoidalOintment
  • Non Proprietary Name:
  • Active Ingredient(s): 14 g/100g MINERAL OIL; 74.9 g/100g PETROLATUM; .25 g/100g PHENYLEPHRINE HYDROCHLORIDE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Adrenergic alpha1-Agonists [MoA]; alpha-1 Adrenergic Agonist [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Trifecta Pharmaceuticals Usa Llc
Product Type:
FDA Application Number: part346
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:12/29/2016

Package Information

No. Package Code Package Description Billing Unit
169396-020-011 TUBE in 1 BOX (69396-020-01) / 28.4 g in 1 TUBE
269396-020-021 TUBE in 1 BOX (69396-020-02) / 56 g in 1 TUBEGM
369396-020-051 TUBE in 1 BOX (69396-020-05) / 15 g in 1 TUBE
469396-020-333 TUBE in 1 BOX (69396-020-33) / 56 g in 1 TUBE
569396-020-444 TUBE in 1 BOX (69396-020-44) / 56 g in 1 TUBE

NDC Record

Field Name Field Value Definition
PRODUCT NDC69396-020The 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.
PROPRIETARY NAMEHemorrhoidalOintmentThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE12/29/2016This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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.
APPLICATION NUMBERpart346This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMETrifecta Pharmaceuticals Usa LlcName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC69396-020The 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.
PROPRIETARY NAMEHemorrhoidalOintmentThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/4/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct 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.
APPLICATION NUMBERM015This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMETrifecta Pharmaceuticals USA LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 7/4/2025

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