FDA.reportPublic FDA data

Stopain Extra Strength Gel

Product NDC
63936-8802
11-digit product format
639368802
Labeler code
63936
Product ID
63936-8802_3a8599cf-1894-9687-e063-6294a90a4518
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Troy Manufacturing, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-15
Substance
MENTHOL
Active strength
80 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stopain Extra Strength Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL80 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui283257, 1541592

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63936-8802-1Stopain Extra Strength Gel10 in 1 BOXGEL102
63936-8802-1Stopain Extra Strength Gel3 g in 1 PACKETGEL32

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283257menthol 8 % Topical GelPSN8bb89002-d7a2-4bee-b5a5-1fd1949273ef2
1541592Stopain COLD 8 % Topical GelPSN8bb89002-d7a2-4bee-b5a5-1fd1949273ef2
1541592menthol 0.08 MG/MG Topical Gel [Stopain]SBD8bb89002-d7a2-4bee-b5a5-1fd1949273ef2
283257menthol 0.08 MG/MG Topical GelSCD8bb89002-d7a2-4bee-b5a5-1fd1949273ef2
283257menthol 8 % Topical GelSY8bb89002-d7a2-4bee-b5a5-1fd1949273ef2
1541592Stopain 0.08 MG/MG Topical GelSY8bb89002-d7a2-4bee-b5a5-1fd1949273ef2
1541592Stopain 8 % Topical GelSY8bb89002-d7a2-4bee-b5a5-1fd1949273ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63936-8802-16393688020110 PACKET in 1 BOX (63936-8802-1) / 3 g in 1 PACKET10 packet2025-06-15NoNoHistorical