FDA.reportPublic FDA data

Equaline Hemorrhoidal

Product NDC
41163-944
11-digit product format
411630944
Labeler code
41163
Product ID
41163-944_f26501df-99c2-4871-a264-68bad975c0f8
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; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM
Active strength
14.4; .25; 1; 15 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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Equaline Hemorrhoidal
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
04JA59TNSJInternal UNII lookup
88AYB867L5Internal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293649Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bf87824a-522d-46da-81b6-e30ea11a2235Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 20 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Preparation H Cooling GelPHENYLEPHRINE HCL, WITCH HAZELHaleon US Holdings LLCcebee3f7-8591-e4f7-e66a-e43b4ba3aaf42024-04-05WarningsExact identifier
application number: M015
PREPARATION H Maximum StrengthGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLHaleon US Holdings LLC7cc03d2e-e708-589a-d9bb-58ebbda989c02024-04-05WarningsExact identifier
application number: M015
Preparation HCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZELHaleon US Holdings LLC2f370875-0225-47b7-b43f-8fa4600d2a0e2024-04-05WarningsExact identifier
application number: M015
PREPARATION HCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa23ded81-78ba-c199-a8f0-aaf360b216ff2024-03-02WarningsExact identifier
application number: M015
PREPARATION H MEDICATED WIPESWITCH HAZELHaleon US Holdings LLC3b1cfa8a-942f-471e-b7c0-744f83b687a02024-03-02WarningsExact identifier
application number: M015
PREPARATION H HYDROCORTISONEHYDROCORTISONEHaleon US Holdings LLCb8d531eb-4012-0450-0e4b-70a8084640412024-02-29WarningsExact identifier
application number: M015
PREPARATION HMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLHaleon US Holdings LLC507c08ab-a98b-33fe-e2ac-eb9b9a810d5a2024-02-29WarningsExact identifier
application number: M015
Preparation H Rapid ReliefLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC27db1d58-4609-4a80-af2f-9e36f10482e12024-02-29WarningsExact identifier
application number: M015
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC699310e8-1a93-40b4-a8f4-a765be4a0cb12024-02-29WarningsExact identifier
application number: M015
Numquick AnalgesicEPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDEUnit Dose, Ltd.b66e7a91-9e35-64dd-e053-2a95a90a8b832024-02-28WarningsExact identifier
application number: M015
Medicated Wipes Hemorroidal Wipes With Witch HazelWITCH HAZELWuhan Zonsen Medical Products Co., Ltd.12441e46-5490-d45c-e063-6394a90a39e32024-02-26WarningsExact identifier
application number: M015
Lidocaine HemorrhoidLIDOCAINE HCL, PHENYLEPHRINE HCL, WITCH HAZELWalgreens Co10a47899-f4a0-66e8-e063-6394a90a11dd2024-02-05WarningsExact identifier
application number: M015
ER HemorrhoidPHENYLEPHRINE HCLEVER READY FIRST AID3cf29fc0-af4d-4610-a426-894601d5e0782024-02-02WarningsExact identifier
application number: M015
RRHOID RAGE HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEPOPPY COLLECTIVE LLCa02a6398-0acd-4aa7-8320-ac586ff12eb32024-01-31WarningsExact identifier
application number: M015
No More ProductsGLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc102e7dbb-06dc-f4d1-e063-6394a90aa3eb2024-01-26WarningsExact identifier
application number: M015
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc.0fe10710-ac59-4fc5-e063-6294a90a48fc2024-01-26WarningsExact identifier
application number: M015
Prosoria Anti-Itch MoisturizerPRAMOXINE HYDROCHLORIDENuvothera, Inc.3c4b9515-f435-4227-a347-d6508778426d2024-01-10WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCICardinal Health 110 dba LEADERa5a261c2-1f36-c895-e053-2a95a90ab22b2024-01-02WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLProficient Rx LP105095e3-843e-4153-adc9-266dd14929a22024-01-01WarningsExact identifier
application number: M015
Family Wellness HEMORRHOIDGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLFAMILY DOLLAR (Family Wellness)16ceb129-5c0a-428a-a867-cfbbb08bb62a2023-12-11WarningsExact identifier
application number: M015

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