NDC 68784-101

Hemorrhoidal

Cocoa Butter, Phenylephrine Hydrochloride

Hemorrhoidal is a Rectal Suppository in the Human Otc Drug category. It is labeled and distributed by Acino Products, Llc.. The primary component is Cocoa Butter; Phenylephrine Hydrochloride.

Product ID68784-101_9fbf7acd-f075-4a82-a47d-d0484055bfc5
NDC68784-101
Product TypeHuman Otc Drug
Proprietary NameHemorrhoidal
Generic NameCocoa Butter, Phenylephrine Hydrochloride
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2014-04-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameAcino Products, LLC.
Substance NameCOCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength1769 mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68784-101-12

12 BLISTER PACK in 1 BOX (68784-101-12) > 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date2021-04-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68784-101-12 [68784010112]

Hemorrhoidal SUPPOSITORY
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-04-01
Inactivation Date2020-01-31

NDC 68784-101-24 [68784010124]

Hemorrhoidal SUPPOSITORY
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-04-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
COCOA BUTTER1768.8 mg/1

OpenFDA Data

SPL SET ID:abfbc71b-40cc-43d1-85af-6a7ca7cc2a9b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1438497

    • NDC Crossover Matching brand name "Hemorrhoidal" or generic name "Cocoa Butter, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0363-0188Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    0363-0279Hemorrhoidalcocoa butter, phenylephrine HCl
    0363-0944hemorrhoidalglycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
    0536-1288HemorrhoidalMineral Oil, Petrolatum, Phenylephrine HCI
    0904-6977HemorrhoidalHard Fat, Phenylephrine HCl
    11822-0006Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    11822-2944Hemorrhoidalglycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
    30142-188Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    30142-279hemorrhoidalcocoa butter, phenylephrine HCl
    30142-944hemorrhoidalglycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
    37012-279hemorrhoidalcocoa butter, phenylephrine HCl
    37808-188Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    37808-279hemorrhoidalcocoa butter, phenylephrine HCl
    37808-944hemorrhoidalglycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
    41250-188hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    41250-279hemorrhoidalcocoa butter, phenylephrine HCl
    41250-944hemorrhoidalglycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
    45802-188Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    51316-228HEMORRHOIDALMINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
    53943-989HemorrhoidalMineral oil Petrolatum Phenylephrine HCl
    54162-044HemorrhoidalMineral Oil, Petrolatum, Phenylephrine
    54162-045HEMORRHOIDALHEMORRHOIDAL
    55319-343HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
    56062-188Hemorrhoidalmineral oil, petrolatum, phenylephrine HCl
    68784-101HemorrhoidalHemorrhoidal
    69842-785HemorrhoidalHemorrhoidal
    70795-1021HemorrhoidalHemorrhoidal
    56062-279hemorrhoidalhemorrhoidal
    59779-669HemorrhoidalHemorrhoidal
    59779-944HemorrhoidalHemorrhoidal
    59970-049HemorrhoidalHemorrhoidal
    59779-279hemorrhoidalhemorrhoidal
    63187-505HemorrhoidalHemorrhoidal
    63868-208HemorrhoidalHemorrhoidal
    63941-161HemorrhoidalHemorrhoidal
    63941-201HemorrhoidalHemorrhoidal
    67510-0056HemorrhoidalHemorrhoidal
    76168-403HemorrhoidalHemorrhoidal
    68016-322HemorrhoidalHemorrhoidal
    56062-944hemorrhoidalhemorrhoidal
    43749-470Avedana HemorrhoidalHemorrhoidal
    11673-395COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDECOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
    11822-0450HEMORRHOID RELIEFCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
    0573-2880PREPARATION Hcocoa butter, phenylephrine hydrochloride
    0573-2883PREPARATION Hcocoa butter, phenylephrine hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.