FDA.reportPublic FDA data

Stopain Extra Strength Gel

Product NDC
63936-8800
11-digit product format
639368800
Labeler code
63936
Product ID
63936-8800_4f9a5912-f600-2b92-e063-6294a90ad5f1
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
2022-10-10
Substance
MENTHOL
Active strength
80 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stopain Extra Strength Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui283257, 1541592

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63936-8800-1Stopain Extra Strength Gel3785 mL in 1 BOTTLEGEL37858
63936-8800-2Stopain Extra Strength Gel946 mL in 1 BOTTLEGEL9468
63936-8800-3Stopain Extra Strength Gel473 mL in 1 BOTTLEGEL4738
63936-8800-4Stopain Extra Strength Gel88 mL in 1 TUBEGEL888

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63936-8800STOPAIN EXTRA STRENGTH GEL (MENTHOL) GEL [TROY MANUFACTURING, INC.]6Current NDC, Legacy NDC, 4 package rows20250429_86fe4e8c-5279-445a-a19a-e694eac785fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283257menthol 8 % Topical GelPSN86fe4e8c-5279-445a-a19a-e694eac785fd8
1541592Stopain COLD 8 % Topical GelPSN86fe4e8c-5279-445a-a19a-e694eac785fd8
1541592menthol 0.08 MG/MG Topical Gel [Stopain]SBD86fe4e8c-5279-445a-a19a-e694eac785fd8
283257menthol 0.08 MG/MG Topical GelSCD86fe4e8c-5279-445a-a19a-e694eac785fd8
283257menthol 8 % Topical GelSY86fe4e8c-5279-445a-a19a-e694eac785fd8
1541592Stopain 0.08 MG/MG Topical GelSY86fe4e8c-5279-445a-a19a-e694eac785fd8
1541592Stopain 8 % Topical GelSY86fe4e8c-5279-445a-a19a-e694eac785fd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63936-8800-1639368800013785 mL in 1 BOTTLE (63936-8800-1) 3785 ml2022-10-100000-00-00NoNoCurrent
63936-8800-263936880002946 mL in 1 BOTTLE (63936-8800-2) 946 ml2022-10-100000-00-00NoNoCurrent
63936-8800-363936880003473 mL in 1 BOTTLE (63936-8800-3) 473 ml2022-10-100000-00-00NoNoCurrent
63936-8800-46393688000488 mL in 1 TUBE (63936-8800-4) 88 ml2023-10-01NoNoHistorical