NDC 0573-2880

PREPARATION H

Cocoa Butter, Phenylephrine Hydrochloride

PREPARATION H is a Rectal Suppository in the Human Otc Drug category. It is labeled and distributed by Wyeth Consumer Healthcare Llc. The primary component is Cocoa Butter; Phenylephrine Hydrochloride.

Product ID0573-2880_32705e4a-6171-4df2-bce9-409272c9dacf
NDC0573-2880
Product TypeHuman Otc Drug
Proprietary NamePREPARATION H
Generic NameCocoa Butter, Phenylephrine Hydrochloride
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2004-01-05
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameWyeth Consumer Healthcare LLC
Substance NameCOCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength2211 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0573-2880-31

48 BLISTER PACK in 1 CARTON (0573-2880-31) > 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date2004-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0573-2880-31 [00573288031]

PREPARATION H SUPPOSITORY
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2004-01-05

Drug Details

Active Ingredients

IngredientStrength
COCOA BUTTER2211 mg/1

OpenFDA Data

SPL SET ID:a23ded81-78ba-c199-a8f0-aaf360b216ff
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1438497
  • 1438502
  • NDC Crossover Matching brand name "PREPARATION H" or generic name "Cocoa Butter, Phenylephrine Hydrochloride"

    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
    11673-395COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDECOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
    59779-401COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDECOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
    11822-0450HEMORRHOID RELIEFCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
    55319-343HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
    63868-208HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
    68784-101HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
    70795-1021HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.