NDC 0904-6356

Major Prep Hemorrhoidal

Mineral Oil, Petrolatum, Phenylephrine Hydrochloride

Major Prep Hemorrhoidal is a Rectal; Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Mineral Oil; Petrolatum; Phenylephrine Hydrochloride.

Product ID0904-6356_daf43ce5-e0d1-4309-8490-fe08bf628c77
NDC0904-6356
Product TypeHuman Otc Drug
Proprietary NameMajor Prep Hemorrhoidal
Generic NameMineral Oil, Petrolatum, Phenylephrine Hydrochloride
Dosage FormOintment
Route of AdministrationRECTAL; TOPICAL
Marketing Start Date2014-06-03
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameMajor Pharmaceuticals
Substance NameMINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength140 mg/g; mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-6356-02

1 TUBE in 1 CARTON (0904-6356-02) > 57 g in 1 TUBE
Marketing Start Date2016-10-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6356-02 [00904635602]

Major Prep Hemorrhoidal OINTMENT
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2016-10-11

Drug Details

Active Ingredients

IngredientStrength
MINERAL OIL140 mg/g

OpenFDA Data

SPL SET ID:3db88d5e-525b-40ed-884a-1788cc5627aa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1372298
  • UPC Code
  • 0309046356028
  • NDC Crossover Matching brand name "Major Prep Hemorrhoidal" or generic name "Mineral Oil, Petrolatum, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0904-5304Major Prep Hemorrhoidalhard fat, phenylephrine HCl
    0904-6356Major Prep HemorrhoidalMineral Oil, Petrolatum, Phenylephrine Hydrochloride
    0904-6726major prep hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    51141-0230ATOPALM HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
    49781-077Leader HemorrholidalMineral Oil, Petrolatum, Phenylephrine Hydrochloride

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