2.5% Menthol PAIN RELIEF

Product NDC
52000-440
11-digit product format
520000440
Labeler code
52000
Product ID
52000-440_8b302a49-b577-429b-b508-b386e56c2af3
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-19
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
25 mg/g
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
2.5% Menthol PAIN RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM25 mg/g

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
282805Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c842544a-6aea-42af-a77e-7b202371b387Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-440-022.5% Menthol PAIN RELIEF57 g in 1 TUBEGEL571
52000-440-022.5% Menthol PAIN RELIEF1 in 1 BOXGEL11

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 98 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thera Plus Hydrocortisone Maximum StrengthHYDROCORTISONEFOURSTAR GROUP USA, INC.c2bc8f0c-38ea-4124-bc51-bf22e6751a922025-03-04WarningsExact identifier
application number: M017
Thera Plus Eczema Hydrocortisone Anti ItchHYDROCORTISONEFourstar Group USA, Inc.7c72217b-db9a-4573-9f14-4c11528fa4522025-03-04WarningsExact identifier
application number: M017
Thera Plus Maximum Strength HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.fb89dca6-c0c0-4092-b3f5-e59c956c3d6c2025-03-04WarningsExact identifier
application number: M017
Peppermint soothing creamCAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM, BORNEOLHenan Lijitang Medical Technology Co., Ltd.2f6bc332-3006-710d-e063-6394a90acea52025-03-03WarningsExact identifier
application number: M017
Thera Plus Pain Relief Arthritis and MuscleCAPSAICINFOURSTAR GROUP USA, INC.dcff0a2d-7190-4b0c-abde-ba009b8ef0052025-02-28WarningsExact identifier
application number: M017
GoodSense Anti-ItchDIPHENHYDRAMINE HCL, ZINC ACETATEGeiss, Destin & Dunn, Inc2f38bdfc-6135-1b8a-e063-6294a90a67032025-02-28WarningsExact identifier
application number: M017
Capsaicin 0.05% CreamCAPSAICIN 0.05%Puretek Corporation2cf17a28-711f-77bd-e063-6394a90a70612025-02-28WarningsExact identifier
application number: M017
Lidocaine Pain-Relief PatchesLIDOCAINE PATCHMeijer, Inc2f247929-6bff-1e59-e063-6394a90acdba2025-02-27WarningsExact identifier
application number: M017
Lightning Products BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.555ac696-e761-4a5a-bed8-945dc64d5be52025-02-27WarningsExact identifier
application number: M017
Hydrocortisone with aloeHYDROCORTISONEEncube Ethicals, Inc.12a1774d-a97e-4787-b6b1-8e8cd40b7b702025-02-26WarningsExact identifier
application number: M017
Thera Plus Maximum Strength Feminine Anti-ItchBENZOCAINE, RESORCINOLFOURSTAR GROUP USA, INC.0007e3ea-882b-4000-8e70-2bcec2c086132025-02-26WarningsExact identifier
application number: M017
Tattoo numbing creamLIDOCAINEBLOOMWELL GARDENS LLC2ea9d34e-408d-f8d6-e063-6394a90a72a42025-02-26WarningsExact identifier
application number: M017
Icy Hot Pro No-MessCAMPHOR, MENTHOLChattem, Inc.9e8fedf5-fb59-4531-b288-715f851ee05b2025-02-26WarningsExact identifier
application number: M017
Family Wellness Max Strength 1 Hydrocortisone CreamHYDROCORTISONEFamily Dollar Stores, Incbca5ac2c-45cd-44e3-98f1-317a04e44d7d2025-02-25WarningsExact identifier
application number: M017
Tylenol Precise Nighttime Pain RelievingCAMPHOR, MENTHOLKenvue Brands LLC2ef4fe16-0820-6aad-e063-6294a90a84492025-02-25WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEPreferred Pharmaceuticals Inc.c259ef92-5d07-4590-adf1-3a106333eee02025-02-21WarningsExact identifier
application number: M017
Cortizone 10 Ultra Soothing Itch ReliefHYDROCORTISONEChattem, Inc.8a9e2d32-a65f-4253-8041-4146f4e3b7382025-02-21WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll OnMENTHOLADP Health Limited420d8cdc-f47f-4d33-bf25-9033ff266c492025-02-19WarningsExact identifier
application number: M017
AVCOO Pain ReliefMENTHOLADP Health Limited700ce2cf-749e-40be-91c3-850d9b2168ca2025-02-19WarningsExact identifier
application number: M017
Sunburn Relief GelLIDOCAINE HCLJell Pharmaceuticals Pvt. Ltd2e7c49de-5438-4858-e063-6294a90ad98c2025-02-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282805menthol 2.5 % Topical GelPSNc842544a-6aea-42af-a77e-7b202371b3871
282805menthol 0.025 MG/MG Topical GelSCDc842544a-6aea-42af-a77e-7b202371b3871
282805menthol 2.5 % Topical GelSYc842544a-6aea-42af-a77e-7b202371b3871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52000-440-02520000440021 TUBE in 1 BOX (52000-440-02) / 57 g in 1 TUBE1 tube2026-01-19NoNoCurrent