FDA.reportPublic FDA data

equate hemorrhoidal

Product NDC
49035-944
11-digit product format
490350944
Labeler code
49035
Product ID
49035-944_60927fd2-6ace-4350-8acc-14803790229d
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
Wal-Mart Stores Inc
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-09-25
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
equate 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
49035-944-24equate hemorrhoidal51 g in 1 TUBECREAM515
49035-944-24equate hemorrhoidal1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-944-24GM - Gram49035-94432721f9d-b12b-4b0d-877f-3ee3a6a775a912015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
PETROLATUMACTIVE INGREDIENT4T6H12BN9UEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5EQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
GLYCERINACTIVE MOIETYPDC6A3C0OXEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
PETROLATUMACTIVE MOIETY4T6H12BN9UEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
PRAMOXINEACTIVE MOIETY068X84E056EQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1EQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311EQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4EQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
LAURETH-23INACTIVE INGREDIENTN72LMW566GEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92EQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
STEARETH-2INACTIVE INGREDIENTV56DFE46J5EQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08EQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
WATERINACTIVE INGREDIENT059QF0KO0REQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEEQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-944EQUATE HEMORRHOIDAL (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WAL-MART STORES INC]5Current NDC, Legacy NDC, 2 package rows20240927_5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d.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 CreamPSN5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d5
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d5
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-944-24490350944241 TUBE in 1 CARTON (49035-944-24) / 51 g in 1 TUBE1 tube2007-09-250000-00-00NoNoCurrent