NDC 0573-2871

PREPARATION H

Mineral Oil, Petrolatum, Phenylephrine Hcl

PREPARATION H is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Mineral Oil; Petrolatum; Phenylephrine Hydrochloride.

Product ID0573-2871_26efba95-f879-46c4-bcdd-d52091f5d2a6
NDC0573-2871
Product TypeHuman Otc Drug
Proprietary NamePREPARATION H
Generic NameMineral Oil, Petrolatum, Phenylephrine Hcl
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2004-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameMINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength140 mg/g; mg/g; mg/g
Pharm ClassesAdrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0573-2871-04

2 CARTON in 1 PACKAGE (0573-2871-04) > 1 TUBE in 1 CARTON > 57 g in 1 TUBE
Marketing Start Date2004-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0573-2871-94 [00573287194]

PREPARATION H OINTMENT
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-05-17

NDC 0573-2871-93 [00573287193]

PREPARATION H OINTMENT
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2019-06-01

NDC 0573-2871-92 [00573287192]

PREPARATION H OINTMENT
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 0573-2871-91 [00573287191]

PREPARATION H OINTMENT
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 0573-2871-04 [00573287104]

PREPARATION H OINTMENT
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2004-03-01

NDC 0573-2871-10 [00573287110]

PREPARATION H OINTMENT
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2004-03-01

NDC 0573-2871-20 [00573287120]

PREPARATION H OINTMENT
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2004-03-01

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g

OpenFDA Data

SPL SET ID:507c08ab-a98b-33fe-e2ac-eb9b9a810d5a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1427404
  • 1372298
    • UPC Code
  • 0305732871103

    • NDC Crossover Matching brand name "PREPARATION H" or generic name "Mineral Oil, Petrolatum, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    0573-2868PREPARATION Hglycerin, petrolatum, phenylephrine HCl, pramoxine HCl
    0573-2871PREPARATION Hmineral oil, petrolatum, phenylephrine HCl
    0573-2880PREPARATION Hcocoa butter, phenylephrine hydrochloride
    0573-2883PREPARATION Hcocoa butter, phenylephrine hydrochloride
    0573-2884Preparation Hcocoa butter, phenylephrine hydrochloride, and witch hazel
    0573-2889Preparation Hwitch hazel
    43749-480Avedana Hemorrhoidal Pain ReliefMineral Oil, Petrolatum, Phenylephrine HCl
    0113-7188basic care hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    27293-026Budpak Hemorrhoid AnestheticMineral Oil, Petrolatum, Phenylephrine HCL
    41520-188careone hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    41163-188Equaline Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    49035-188Equate Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    0113-0188Good Sense Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    47046-153Hemorrhoid AnestheticMineral Oil, Petrolatum, Phenylephrine HCL
    0363-0188Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    11822-0006Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    30142-188Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    37808-188Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    41250-188hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    45802-188Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    11822-0188hemorrhoidal reliefmineral oil, petrolatum, phenylephrine HCl
    0904-6726major prep hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    0363-5188pain reliefmineral oil, petrolatum, phenylephrine HCl
    21130-577signature care hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    49348-198Sunmark Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    36800-188Topcare hemorrhoidalMineral oil, petrolatum, phenylephrine hcl
    36800-499topcare hemorrhoidalmineral oil, petrolatum, phenylephrine HCl

    Trademark Results [PREPARATION H]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PREPARATION H
    PREPARATION H
    72218523 0807467 Live/Registered
    AMERICAN HOME PRODUCTS CORPORATION
    1965-05-11
    PREPARATION H
    PREPARATION H
    72093736 0706552 Live/Registered
    AMERICAN HOME PRODUCTS CORPORATION
    1960-03-28
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.