FDA.reportPublic FDA data

topcare hemorrhoidal

Product NDC
36800-944
11-digit product format
368000944
Labeler code
36800
Product ID
36800-944_ff52b31c-4839-455f-af93-e0ca45c09784
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-11-03
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
topcare 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
36800-944-24topcare hemorrhoidal1 in 1 CARTONCREAM14
36800-944-24topcare hemorrhoidal51 g in 1 TUBECREAM514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-944-24GM - Gram36800-9440e85e6db-a6cf-40b3-8e2a-675ec6eaa53912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5TOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
GLYCERINACTIVE MOIETYPDC6A3C0OXTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
PETROLATUMACTIVE MOIETY4T6H12BN9UTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
PRAMOXINEACTIVE MOIETY068X84E056TOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1TOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311TOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4TOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
LAURETH-23INACTIVE INGREDIENTN72LMW566GTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92TOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
STEARETH-2INACTIVE INGREDIENTV56DFE46J5TOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08TOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-944TOPCARE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 2 package rows20241016_5e13da07-48cf-40bc-bb11-fd891886cbea.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 CreamPSN5e13da07-48cf-40bc-bb11-fd891886cbea4
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD5e13da07-48cf-40bc-bb11-fd891886cbea4
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY5e13da07-48cf-40bc-bb11-fd891886cbea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-944-24368000944241 TUBE in 1 CARTON (36800-944-24) / 51 g in 1 TUBE1 tube2011-11-030000-00-00NoNoCurrent