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 10 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLPranicura Products LLCaf520a58-3f3c-4d28-a41f-3ed8f74da0952025-11-04WarningsExact identifier
application number: M015
ProCure ClamaPlexZINC OXIDE 20.625, MENTHOL 0.44, WHITE PETROLATUM 66.335Twin Med LLC3d366857-5178-9032-e063-6294a90a40f32025-11-01WarningsExact identifier
application number: M015
GNP HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCLAmerisource Bergenb0f0ef97-9add-717f-e053-2a95a90a0eb02025-10-30WarningsExact identifier
application number: M015
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
application number: M015
Hemorrhoid AnestheticMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUniversal Distribution Center LLC186c2d32-e8c5-d13d-e063-6294a90a2b0e2025-10-30WarningsExact identifier
application number: M015
WorkvieLIDOCAINE HCL, MENTHOLMarketites LLCaebaffb5-58dd-ebd5-e053-2a95a90a14ed2025-10-29WarningsExact identifier
application number: M015
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLPharmacy Value Alliance LLC903b77fc-02bf-73b6-e053-2a95a90ad4cc2025-10-24WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLCVS Pharmacy845fc11b-707d-2027-e053-2991aa0a1c8a2025-10-24WarningsExact identifier
application number: M015
Calmol 4ZINC OXIDE AND COCOA BUTTERResical Inc.5516f800-d3fa-4b90-a3eb-c0bdf3183b9b2025-10-24WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLAmerisourcebergen Drug Corporation231a850a-bad6-9a30-e063-6394a90a0fdc2025-10-24WarningsExact identifier
application number: M015
Signature Care Hemorrhoidal Cream (with applicator)PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUMBETTER LIVING BRANDS, LLCb026a386-5e38-52ed-e053-2a95a90a6b0e2025-10-24WarningsExact identifier
application number: M015
AmericaineBENZOCAINEInsight Pharmaceuticals LLCd13c022f-2f91-40b4-bd66-0cfc0e147a5f2025-10-23WarningsExact identifier
application number: M015
Winco HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEWinco Foods, LLC04ca3ef1-fc6b-4683-b236-a75afc031fb52025-10-23WarningsExact identifier
application number: M015
Signature Care Medicated CoolingWITCH HAZELBetter Living Brands, LLCb35dc719-a5a2-4839-870d-25313d3f7c9b2025-10-22WarningsExact identifier
application number: M015
Family Care HemorrhoidalMINERAL OILUnited Exchange Corp04375257-f4f3-48c3-a338-de43298b95eb2025-10-22WarningsExact identifier
application number: M015
Family Wellness HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCLFamily Dollar Services, Incfe3293bc-80b5-b60a-e053-6394a90a4ede2025-10-22WarningsExact identifier
application number: M015
Xesso Rear Comfort GlideLIDOCAINEPREMIUM NATURAL COSMETICS INCe9eb262e-a1c1-7d5c-e053-2a95a90a7c9f2025-10-22WarningsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.41a6d309-2722-1738-e063-6294a90a8a702025-10-21WarningsExact identifier
application number: M015
DERMOSCRIBE ICHYBUMHYDROCORTISONE, CLIOQUINOL, ZINC OXIDEDERMOSCRIBE PTY LTD134a88a1-13e5-4da0-8270-c380b57aaeb72025-10-17WarningsExact 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