FDA.reportPublic FDA data

Hemorrhoidal

Product NDC
59779-944
11-digit product format
597790944
Labeler code
59779
Product ID
59779-944_7fd015de-8ee7-40fc-b530-993a653af5f1
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-02-06
Substance
GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength
14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hemorrhoidal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN14.4 g/100g
PETROLATUM15 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g
PRAMOXINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, 4T6H12BN9U, 04JA59TNSJ, 88AYB867L5
Rxcui1293649

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-944-24Hemorrhoidal1 in 1 CARTONCREAM125
59779-944-24Hemorrhoidal51 g in 1 TUBECREAM5125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-944-24GM - Gram59779-9443d62d39c-ad9c-4a19-b774-091b8ef217c612018-05-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
PETROLATUMACTIVE INGREDIENT4T6H12BN9UHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
GLYCERINACTIVE MOIETYPDC6A3C0OXHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
PETROLATUMACTIVE MOIETY4T6H12BN9UHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
PRAMOXINEACTIVE MOIETY068X84E056HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
LAURETH-23INACTIVE INGREDIENTN72LMW566GHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
STEARETH-2INACTIVE INGREDIENTV56DFE46J5HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
WATERINACTIVE INGREDIENT059QF0KO0RHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEHEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-944HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [CVS PHARMACY]25Current NDC, Legacy NDC, 2 package rows20240913_3167c918-a7d3-46a1-a85b-64f9c22916f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN3167c918-a7d3-46a1-a85b-64f9c22916f225
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD3167c918-a7d3-46a1-a85b-64f9c22916f225
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY3167c918-a7d3-46a1-a85b-64f9c22916f225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-944-24597790944241 TUBE in 1 CARTON (59779-944-24) / 51 g in 1 TUBE1 tube2008-02-060000-00-00NoNoCurrent