NDC 36800-188

Topcare hemorrhoidal

Mineral Oil, Petrolatum, Phenylephrine Hcl

Topcare hemorrhoidal is a Rectal Ointment in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Mineral Oil; Petrolatum; Phenylephrine Hydrochloride.

Product ID36800-188_09ea59a7-267c-4e91-a671-2856b96cc2e0
NDC36800-188
Product TypeHuman Otc Drug
Proprietary NameTopcare hemorrhoidal
Generic NameMineral Oil, Petrolatum, Phenylephrine Hcl
Dosage FormOintment
Route of AdministrationRECTAL
Marketing Start Date2013-07-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameTopco Associates LLC
Substance NameMINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength140 mg/100g; mg/100g; mg/100g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36800-188-16

1 TUBE in 1 CARTON (36800-188-16) > 57 g in 1 TUBE
Marketing Start Date2013-07-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-188-16 [36800018816]

Topcare hemorrhoidal OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-07-22
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
MINERAL OIL140 mg/100g

OpenFDA Data

SPL SET ID:51521353-a859-4d6b-84eb-6523e780989c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1372298
  • UPC Code
  • 0036800035034