4% Menthol PAIN RELIEF

Product NDC
52000-439
11-digit product format
520000439
Labeler code
52000
Product ID
52000-439_8beb3f46-515f-4b8d-ad05-06be2df6ca08
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
4 g/100mL
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
4% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLC7fb95135-4151-4ef4-bb6d-75251cafff6c2026-01-09WarningsExact identifier

Warnings cross-check#

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

warnings

Warnings For external use only. Flammable: Keep away from excessive heat or open flame When using this product • use only as directed • avoid contact with the eyes or on mucous membranes • do not apply to wounds or damaged skin • do not apply to irritated skin or if excessive irritation develops • do not bandage tightly or use with heating pad or device Stop use and ask a doctor if ​• you experience pain, swelling or blistering of the skin • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
4% Menthol PAIN RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui415974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-439-254% Menthol PAIN RELIEF74 mL in 1 BOTTLEGEL741

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN7fb95135-4151-4ef4-bb6d-75251cafff6c1
415974menthol 0.04 MG/MG Topical GelSCD7fb95135-4151-4ef4-bb6d-75251cafff6c1
415974menthol 4 % Topical GelSY7fb95135-4151-4ef4-bb6d-75251cafff6c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52000-439-255200004392574 mL in 1 BOTTLE (52000-439-25) 74 ml2026-01-19NoNoCurrent