FDA.reportPublic FDA data

Topical Hemorrhoid Relief Gel

Product NDC
87512-005
11-digit product format
875120005
Labeler code
87512
Product ID
87512-005_4d6e6667-ab1d-de7c-e063-6294a90a0b9b
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, UNSPECIFIED FORM
Dosage form
GEL
Route
TOPICAL
Labeler
Yantai Aien Biotechnology Co., Ltd.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-20
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
.1 g/100g
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
Topical Hemorrhoid Relief Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2739217Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d6e6667-ab1c-de7c-e063-6294a90a0b9bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87512-005-01Topical Hemorrhoid Relief Gel15 g in 1 TUBEGEL151
87512-005-02Topical Hemorrhoid Relief Gel30 g in 1 TUBEGEL301

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 19 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLMeijer Distribution Inc14319ba4-3bce-497c-a380-65bd24defc5d2024-10-17WarningsExact identifier
application number: M015
equate hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLWal-Mart Stores Inc581dd76f-d052-4448-8139-9a2e31891b252024-10-17WarningsExact identifier
application number: M015
Equate HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWal-Mart Stores Inc81ecb091-38da-4b3e-a0a1-b4986b97ee092024-10-16WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLKroger Company5c81d564-f786-46e1-af8b-f47521fbae602024-10-16WarningsExact identifier
application number: M015
topcare hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTopco Associates LLC615e87e4-79e0-44d6-b563-3bcd5a9b2d932024-10-16WarningsExact identifier
application number: M015
Basic Care HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmazon.com Services LLCfe675174-fc95-4dd7-bd39-c209c6ce0f6c2024-10-16WarningsExact identifier
application number: M015
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMMeijer Distribution Incfb170371-2e5d-43ca-a259-538a973ee3b82024-10-15WarningsExact identifier
application number: M015
topcare hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMTopco Associates LLC5e13da07-48cf-40bc-bb11-fd891886cbea2024-10-14WarningsExact identifier
application number: M015
hemorrhoidal maximum strength pain reliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMKroger Company3c8f90e2-fecf-4439-9faa-81a32ffe47532024-09-26WarningsExact identifier
application number: M015
equate hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWal-Mart Stores Inc5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d2024-09-26WarningsExact identifier
application number: M015
Walgreens Hemorrhoidal Pain ReliefGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Walgreense79ed7ae-0d06-2f88-e053-2995a90a1e352024-09-20WarningsExact identifier
application number: M015
hemorrhoidal reliefCOCOA BUTTER, PHENYLEPHRINE HCLRite Aid Corporationddafbdca-32c2-49c1-83d3-35b4155958c92024-08-15WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLRite Aid Corporation8e1f223a-a3a0-4837-9847-2a3939fcc5952024-08-15WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBryant Ranch Prepack485fd02f-bfea-41d0-90a1-f12fcfeb2a152024-08-14WarningsExact identifier
application number: M015
Up and Up Hemorrhoid MAX STRENGTH14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUMTarget Corporation867677b5-fd1d-449e-966e-1de0b5c98afb2024-08-08WarningsExact identifier
application number: M015
Soothing Hemorrhoidal Wipes 50 Witch HazelWITCH HAZELThe Honey Pot Company LLC1ea202f5-e228-b3f2-e063-6294a90a16c12024-08-01WarningsExact identifier
application number: M015
Bunnies Bum Hemorrhoidal NumbingLIDOCAINEFloCal Distributors LLC1c809643-0cbe-568f-e063-6394a90a32102024-07-05WarningsExact identifier
application number: M015
Bunnies Bum Soothing HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLFloCal Distributors LLC1c81582c-7ece-182f-e063-6294a90a8fbc2024-07-05WarningsExact identifier
application number: M015
MegaBabe Butt Stuff HemorrhoidalCOCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEMEGABABE, LLC01c156ff-69f9-4d5e-a9ea-abbc52d4afff2024-06-12WarningsExact identifier
application number: M015
PUREGEN LABS Maximum Strength LidocaineLIDOCAINEAdvanced Rx LLCf4f89582-49e6-424a-bea7-0694484a7c992024-04-11WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2739217menthol 0.1 % Rectal GelPSN4d6e6667-ab1c-de7c-e063-6294a90a0b9b1
2739217menthol 0.001 MG/MG Rectal GelSCD4d6e6667-ab1c-de7c-e063-6294a90a0b9b1
2739217menthol 0.1 % Rectal GelSY4d6e6667-ab1c-de7c-e063-6294a90a0b9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87512-005-018751200050115 g in 1 TUBE (87512-005-01) 15 g2026-03-20NoNoCurrent
87512-005-028751200050230 g in 1 TUBE (87512-005-02) 30 g2026-03-20NoNoCurrent