FDA.reportPublic FDA data

NUMBING

Product NDC
85524-2605
11-digit product format
855242605
Labeler code
85524
Product ID
85524-2605_4ce416dd-2431-4648-e063-6294a90ab199
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
FlexiGo Inc
Application
NDA022029
Marketing category
NDA
Marketing start
2026-03-28
Substance
MENTHOL; METHYL SALICYLATE
Active strength
3; 10 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NUMBING
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL3 g/100mL
METHYL SALICYLATE10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, LAV5U5022Y
Rxcui1486874

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85524-2605-1NUMBING60 mL in 1 BOTTLECREAM601
85524-2605-2NUMBING1 in 1 BOXCREAM11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486874menthol 3 % / methyl salicylate 10 % Topical CreamPSN4ce416dd-2430-4648-e063-6294a90ab1991
1486874menthol 30 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD4ce416dd-2430-4648-e063-6294a90ab1991
1486874menthol 3 % / methyl salicylate 10 % Topical CreamSY4ce416dd-2430-4648-e063-6294a90ab1991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85524-2605-18552426050160 mL in 1 BOTTLE60 mlHistorical
85524-2605-2855242605021 BOTTLE in 1 BOX (85524-2605-2) / 60 mL in 1 BOTTLE (85524-2605-1) 1 bottle2026-03-28NoNoCurrent