FDA.reportPublic FDA data

Equaline Hemorrhoidal

Product NDC
41163-944
11-digit product format
411630944
Labeler code
41163
Product ID
41163-944_87b21c98-549a-4ff8-89fd-0b7ebdf62725
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-03-28
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
Equaline 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
41163-944-24Equaline Hemorrhoidal1 in 1 CARTONCREAM16
41163-944-24Equaline Hemorrhoidal51 g in 1 TUBECREAM516

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
PETROLATUMACTIVE INGREDIENT4T6H12BN9UEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5EQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
GLYCERINACTIVE MOIETYPDC6A3C0OXEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
PETROLATUMACTIVE MOIETY4T6H12BN9UEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
PRAMOXINEACTIVE MOIETY068X84E056EQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1EQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311EQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4EQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
LAURETH-23INACTIVE INGREDIENTN72LMW566GEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92EQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
STEARETH-2INACTIVE INGREDIENTV56DFE46J5EQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08EQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
WATERINACTIVE INGREDIENT059QF0KO0REQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEEQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [SUPERVALU INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-944EQUALINE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [UNITED NATURAL FOODS, INC. DBA UNFI]6Current NDC, Legacy NDC, 2 package rows20240927_bf87824a-522d-46da-81b6-e30ea11a2235.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 CreamPSNbf87824a-522d-46da-81b6-e30ea11a22356
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCDbf87824a-522d-46da-81b6-e30ea11a22356
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSYbf87824a-522d-46da-81b6-e30ea11a22356

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-944-24411630944241 TUBE in 1 CARTON (41163-944-24) / 51 g in 1 TUBE1 tube2008-03-280000-00-00NoNoCurrent