NDC 46084-111

APJ HEMORRHOIDAL

Phenylephrine Hydrochloride, Mineral Oil, Petrolatum

APJ HEMORRHOIDAL is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by A P J Laboratories Limited. The primary component is Phenylephrine Hydrochloride; Petrolatum; Mineral Oil.

Product ID46084-111_a0c485a4-d719-42e7-8764-459756dfdae3
NDC46084-111
Product TypeHuman Otc Drug
Proprietary NameAPJ HEMORRHOIDAL
Generic NamePhenylephrine Hydrochloride, Mineral Oil, Petrolatum
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2013-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameA P J Laboratories Limited
Substance NamePHENYLEPHRINE HYDROCHLORIDE; PETROLATUM; MINERAL OIL
Active Ingredient Strength3 mg/g; mg/g; mg/g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 46084-111-20

57 g in 1 TUBE (46084-111-20)
Marketing Start Date2013-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46084-111-10 [46084011110]

APJ HEMORRHOIDAL OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-07-01
Inactivation Date2019-11-27

NDC 46084-111-20 [46084011120]

APJ HEMORRHOIDAL OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-07-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE2.55 mg/g

OpenFDA Data

SPL SET ID:e971a664-c814-4c8a-96ab-7fdaa974335d
Manufacturer
UNII

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