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 7 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.1cada0ae-3f0f-441c-a633-faa0a3009d2b2026-02-05WarningsExact identifier
application number: M015
Numbing CreamLIDOCAINESainite Trading Shenzhen Co., Ltd.49fcbe81-34b6-5906-e063-6294a90aa65b2026-02-04WarningsExact identifier
application number: M015
Perineal Cooling Pad LinersFRIDA MOM PERINEAL COOLING PAD LINERSFridababy, LLCe9d33d92-34ee-b639-e053-2a95a90a9f362026-02-04WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSportpharm LLC88e3624d-b8bb-4e65-9250-4c51d2bbed162026-02-03WarningsExact identifier
application number: M015
careone hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmerican Sales Company46794d2e-8fe6-490d-9cfa-ba9b6c209ad62026-01-29WarningsExact identifier
application number: M015
LUBRICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.9d98afbf-11ce-745b-e053-2a95a90abc142026-01-28WarningsExact identifier
application number: M015
foster and thrive hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLStrategic Sourcing Services LLC9da843f2-e88c-432e-b091-a6acf81d856b2026-01-22WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLHyVee Incbf1beca0-cc9b-4100-9db7-77f2d1e5497c2026-01-21WarningsExact identifier
application number: M015
GRANULOTION HemorrhoidalMENTHOL, ZINC OXIDEGL Health, Inc.1a32741c-5e4a-40e5-b15a-8233c5bdb92b2026-01-19WarningsExact identifier
application number: M015
HydroseptineZINC OXIDE, MENTHOLAKRON PHARMA INC5359d92e-641e-4076-9d91-18daee58a30e2026-01-19WarningsExact identifier
application number: M015
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
application number: M015
WalgreensHEMORRHOIDAL PAIN RELIEFWalgreensb0b1ce47-9fa4-4505-8f38-39a0d500e9f62026-01-15WarningsExact identifier
application number: M015
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens4276ddad-2363-462a-bb97-574f946ec3f02026-01-15WarningsExact identifier
application number: M015
WalgreensHEMORRHOIDAL COOLING GELWalgreens1277d2e8-2a5e-23f5-e063-6294a90a69b02026-01-15WarningsExact identifier
application number: M015
Hemorrhoid and FissureGLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%FlexiGo Inc48697377-61c0-1b0a-e063-6294a90a32932026-01-15WarningsExact identifier
application number: M015
MEDPURA Vitamin A and D Vitamin A and DMEDPURA VITAMIN A AND DAkron Pharma Inc.38cc2317-691b-4657-af05-c67623eba7602026-01-14WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreens2dd710ac-ab04-4a24-826f-b5a44d0581682026-01-14WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreensca98dea5-767d-49a8-887b-d96cad487fc42026-01-14WarningsExact identifier
application number: M015
Walgreens Moisture BarrierMENTHOL, AND ZINC OXIDEWalgreen Companya6db6f13-4e02-47dc-aef6-a804506c3d8b2026-01-14WarningsExact identifier
application number: M015
GNP Hemorrhoidal Maximum StrengthHEMORRHOIDALAmerisourcebergen Drug Corporation24103355-cd72-55b0-e063-6394a90a90ec2026-01-14WarningsExact 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