FDA.reportPublic FDA data

2.5% Menthol PAIN RELIEF

Product NDC
43473-096
11-digit product format
434730096
Labeler code
43473
Product ID
43473-096_4a21330e-6d27-2425-e063-6294a90a021d
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Nantong Health & Beyond Hygienic Products Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-05
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
25 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2.5% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.8075ba60-772c-4d1a-8584-722bb3e539be2026-02-05WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. Do not use • on wounds or damaged skin • with a heating pad • on a child under 12 years of age with arthritis-like conditions Ask a doctor before use if you have redness over the affected area. When using this product • avoid contact with eyes or mucous membranes • do not bandage tightly Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • excessive skin irritation occurs Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately.

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 Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui282805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43473-096-022.5% Menthol PAIN RELIEF1 in 1 BOXGEL11
43473-096-022.5% Menthol PAIN RELIEF57 g in 1 TUBEGEL571

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282805menthol 2.5 % Topical GelPSN8075ba60-772c-4d1a-8584-722bb3e539be1
282805menthol 0.025 MG/MG Topical GelSCD8075ba60-772c-4d1a-8584-722bb3e539be1
282805menthol 2.5 % Topical GelSY8075ba60-772c-4d1a-8584-722bb3e539be1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43473-096-02434730096021 TUBE in 1 BOX (43473-096-02) / 57 g in 1 TUBE1 tube2026-02-05NoNoCurrent