NDC 55614-610

FARGELIN HEMORRHOIDAL

Calamine, Petrolatum And Phenylephrine Hydrochloride

FARGELIN HEMORRHOIDAL is a Rectal; Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Madison One Acme Inc. The primary component is Zinc Oxide; Ferric Oxide Red; Petrolatum; Phenylephrine Hydrochloride.

Product ID55614-610_902e2427-c910-4242-9497-67d13fde7e5d
NDC55614-610
Product TypeHuman Otc Drug
Proprietary NameFARGELIN HEMORRHOIDAL
Generic NameCalamine, Petrolatum And Phenylephrine Hydrochloride
Dosage FormOintment
Route of AdministrationRECTAL; TOPICAL
Marketing Start Date2019-11-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameMADISON ONE ACME INC
Substance NameZINC OXIDE; FERRIC OXIDE RED; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 g/100g; g/100g; g/100g; g/100g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 55614-610-01

20 g in 1 TUBE, WITH APPLICATOR (55614-610-01)
Marketing Start Date2019-11-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55614-610-01 [55614061001]

FARGELIN HEMORRHOIDAL OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE10.3 g/100g

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