FDA.reportPublic FDA data

hemorrhoidal

Product NDC
30142-944
11-digit product format
301420944
Labeler code
30142
Product ID
30142-944_24a6d187-9260-422f-b527-ee7022fc67a2
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
Kroger Company
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-10-07
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
Brand name suffix
maximum strength pain relief
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
30142-944-24hemorrhoidalmaximum strength pain relief1 in 1 CARTONCREAM15
30142-944-24hemorrhoidalmaximum strength pain relief51 g in 1 TUBECREAM515

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-944HEMORRHOIDAL MAXIMUM STRENGTH PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [KROGER COMPANY]5Current NDC, Legacy NDC, 2 package rows20240927_3c8f90e2-fecf-4439-9faa-81a32ffe4753.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 CreamPSN3c8f90e2-fecf-4439-9faa-81a32ffe47535
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD3c8f90e2-fecf-4439-9faa-81a32ffe47535
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY3c8f90e2-fecf-4439-9faa-81a32ffe47535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-944-24301420944241 TUBE in 1 CARTON (30142-944-24) / 51 g in 1 TUBE1 tube2009-10-070000-00-00NoNoCurrent