4% MENTHOL COLD THERAPY

Product NDC
52000-442
11-digit product format
520000442
Labeler code
52000
Product ID
52000-442_b0944dc2-c53e-45e3-92f0-2b45bcb277a3
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/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
4% MENTHOL COLD THERAPY
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui415974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-442-154% MENTHOL COLD THERAPY42.5 g in 1 TUBEGEL42.51
52000-442-154% MENTHOL COLD THERAPY1 in 1 BOXGEL11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN66892993-a755-4584-b2a8-2e8d7ac705931
415974menthol 0.04 MG/MG Topical GelSCD66892993-a755-4584-b2a8-2e8d7ac705931
415974menthol 4 % Topical GelSY66892993-a755-4584-b2a8-2e8d7ac705931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52000-442-15520000442151 TUBE in 1 BOX (52000-442-15) / 42.5 g in 1 TUBE1 tube2026-01-19NoNoHistorical