SMART PRO

Product NDC
76092-101
11-digit product format
760920101
Labeler code
76092
Product ID
76092-101_fd8d9ad8-bfeb-49b9-90e7-37cf335a8cb5
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
M J Winston International Ltd..
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-07-01
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
1 mg/1; mg/1; mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct76092-101IInactivated by FDA2026-08-17
excluded packagepackage76092-10176092-101-05IInactivated by FDA2026-08-17

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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05IInactivated 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 packagepackage76092-101-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76092-101-052020-01-31C16284748780-19d75b9d0-b521-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76092-101-05SMART PROMEDICATED ANALGESIC PAIN RELIEVING CATAPLASM5 in 1 POUCHPATCH51

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ASMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
MENTHOLACTIVE MOIETYL7T10EIP3ASMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022YSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
ALMASILATEINACTIVE INGREDIENTOZQ8O62H53SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W6SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
GELATININACTIVE INGREDIENT2G86QN327LSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
KAOLININACTIVE INGREDIENT24H4NWX5COSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341LSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ASMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1
WATERINACTIVE INGREDIENT059QF0KO0RSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76092-101SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]1Legacy NDC, 1 package rows20110701_ad334d10-9053-4c40-96a5-db7236564542.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717562camphor 1.2 % / levomenthol 5.7 % / methyl salicylate 6.3 % Medicated PatchPSNad334d10-9053-4c40-96a5-db72365645421
2717562camphor 0.012 MG/MG / levomenthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCDad334d10-9053-4c40-96a5-db72365645421
2717562camphor 1.2 % / levomenthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSYad334d10-9053-4c40-96a5-db72365645421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76092-101-05760920101055 in 1 POUCHHistorical