ActivOn Ultra Strength Arthritis

Product NDC
51068-501
11-digit product format
510680501
Labeler code
51068
Product ID
51068-501_6a97a677-5c25-4d3a-9593-3191f6a981bd
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Histamine Dihydrochloride
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, UNSPECIFIED FORM; HISTAMINE DIHYDROCHLORIDE
Active strength
0 g/g; 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 productproduct51068-501IInactivated by FDA2026-10-15
excluded packagepackage51068-50151068-501-01IInactivated by FDA2026-10-15

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51068-501-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51068-501-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51068-501-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51068-501-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51068-501-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51068-501-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51068-501-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51068-501-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51068-501-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51068-501-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51068-501-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51068-501-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51068-501-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51068-501-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51068-501-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51068-501-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51068-501-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51068-501-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51068-501-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51068-501-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51068-501-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51068-501-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
51068-501-012020-01-31C16284748780-19d75b9d0-19cc-f424-e053-dadaa90a57ceACTIV ON ® Topical Analgesic ULTRA STRENGTH ARTHRITIS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51068-501-01ActivOn Ultra Strength Arthritis1 in 1 CARTONSTICK13
51068-501-01ActivOn Ultra Strength Arthritis57 g in 1 CANISTERSTICK573

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Histamine DihydrochlorideACTIVE INGREDIENT3POA0Q644UACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
Menthol, unspecified formACTIVE INGREDIENTL7T10EIP3AACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
HistamineACTIVE MOIETY820484N8I3ACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
Menthol, unspecified formACTIVE MOIETYL7T10EIP3AACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
alcoholINACTIVE INGREDIENT3K9958V90MACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW4ACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
Edetate SodiumINACTIVE INGREDIENTMP1J8420LUACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
iodopropynyl butylcarbamateINACTIVE INGREDIENT603P14DHEBACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
menthyl lactate, (-)-INACTIVE INGREDIENT2BF9E65L7IACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
sodium stearateINACTIVE INGREDIENTQU7E2XA9TGACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
steareth-21INACTIVE INGREDIENT53J3F32P58ACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
trolamineINACTIVE INGREDIENT9O3K93S3TKACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51068-501ACTIVON ULTRA STRENGTH ARTHRITIS (MENTHOL AND HISTAMINE DIHYDROCHLORIDE) STICK [FAMILY FIRST PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20150423_d123deae-d9ef-45ce-81ed-2d79384b1298.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148636ActivOn Ultra Strength Arthritis (histamine dihydrochloride 0.028 % / menthol 4.574 % ) Topical CreamPSNd123deae-d9ef-45ce-81ed-2d79384b12983
1148634histamine dihydrochloride 0.028 % / menthol 4.57 % Topical CreamPSNd123deae-d9ef-45ce-81ed-2d79384b12983
1148636histamine dihydrochloride 0.28 MG/ML / menthol 45.7 MG/ML Topical Cream [ActivOn Arthritis]SBDd123deae-d9ef-45ce-81ed-2d79384b12983
1148634histamine dihydrochloride 0.28 MG/ML / menthol 45.7 MG/ML Topical CreamSCDd123deae-d9ef-45ce-81ed-2d79384b12983
1148636ActivOn Ultra Strength Arthritis (histamine dihydrochloride 0.028 % / menthol 4.574 % ) Topical CreamSYd123deae-d9ef-45ce-81ed-2d79384b12983
1148634histamine dihydrochloride 0.028 % / menthol 4.574 % Topical CreamSYd123deae-d9ef-45ce-81ed-2d79384b12983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51068-501-01510680501011 in 1 CARTONHistorical