ActivOn Ultra Strength

Product NDC
51068-503
11-digit product format
510680503
Labeler code
51068
Product ID
51068-503_2ab5e94f-2b75-48bc-98d5-81e71f64227b
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
STICK
Route
TOPICAL
Labeler
Family First Pharmaceuticals, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-09-01
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
0 g/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51068-503IInactivated by FDA2026-10-12
excluded packagepackage51068-50351068-503-01IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51068-503-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51068-503-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51068-503-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51068-503-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51068-503-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51068-503-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51068-503-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51068-503-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51068-503-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51068-503-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51068-503-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51068-503-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51068-503-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51068-503-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51068-503-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51068-503-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51068-503-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51068-503-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51068-503-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51068-503-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51068-503-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51068-503-01110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51068-503-012019-10-29C16284748780-1960f7f55-da24-8e05-e053-dbdaa90a074aACTIV ON ® Topical Analgesic ULTRA STRENGTH JOINT & MUSCLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51068-503-01ActivOn Ultra StrengthJoint and Muscle1 in 1 CARTONSTICK12
51068-503-01ActivOn Ultra StrengthJoint and Muscle57 g in 1 CANISTERSTICK572

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3AACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2
MentholACTIVE MOIETYL7T10EIP3AACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2
alcoholINACTIVE INGREDIENT3K9958V90MACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW4ACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2
Edetate SodiumINACTIVE INGREDIENTMP1J8420LUACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2
iodopropynyl butylcarbamateINACTIVE INGREDIENT603P14DHEBACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2
menthyl lactateINACTIVE INGREDIENT2BF9E65L7IACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2
sodium stearateINACTIVE INGREDIENTQU7E2XA9TGACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2
steareth-21INACTIVE INGREDIENT53J3F32P58ACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2
trolamineINACTIVE INGREDIENT9O3K93S3TKACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51068-503ACTIVON ULTRA STRENGTH JOINT AND MUSCLE (MENTHOL) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]2Legacy NDC, 2 package rows20110906_cdf0a374-2a2c-4e79-94f5-23746084d5e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148640ActivOn Ultra Strength Joint & Muscle 5.138 % Topical CreamPSNcdf0a374-2a2c-4e79-94f5-23746084d5e12
1148638menthol 5.14 % Topical CreamPSNcdf0a374-2a2c-4e79-94f5-23746084d5e12
1148640menthol 51.4 MG/ML Topical Cream [ActivOn Joint & Muscle]SBDcdf0a374-2a2c-4e79-94f5-23746084d5e12
1148638menthol 51.4 MG/ML Topical CreamSCDcdf0a374-2a2c-4e79-94f5-23746084d5e12
1148640ActivOn Joint & Muscle 51.4 MG/ML Topical CreamSYcdf0a374-2a2c-4e79-94f5-23746084d5e12
1148640ActivOn Ultra Strength Joint & Muscle 5.138 % Topical CreamSYcdf0a374-2a2c-4e79-94f5-23746084d5e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51068-503-01510680503011 in 1 CARTONHistorical