FDA.reportPublic FDA data

Topcare Pain Relieving 40ct

Product NDC
36800-679
Requested package NDC
36800-679-40
11-digit product format
368000679
Labeler code
36800
Product ID
36800-679_efe6f24d-e0d8-42dc-e053-2995a90a71d3
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor Menthol Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
Topco Associates LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-09-16
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL; MENTHYL SALICYLATE, (+/-)-
Active strength
0 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-67936800-679-40IInactivated by FDA2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
36800-679-402024-01-30C16284748780-11030e365-56e7-111a-e063-dadaa90a10e2TopCare Pain Relieving Patch 40ct (Small) (15679)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-679-40Topcare Pain Relieving 40ct1 g in 1 POUCHPATCH14
36800-679-40Topcare Pain Relieving 40ct40 in 1 BOXPATCH404

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETTOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ATOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
MENTHYL SALICYLATE, (+/-)-ACTIVE INGREDIENT43XOA705ZDTOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETTOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
MENTHOLACTIVE MOIETYL7T10EIP3ATOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZTOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0TOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
NATURAL LATEX RUBBERINACTIVE INGREDIENT2LQ0UUW8INTOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
POLYBUTENE (1400 MW)INACTIVE INGREDIENT1NA5AO9GH7TOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
POLYISOBUTYLENE (1000 MW)INACTIVE INGREDIENT5XB3A63Y52TOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
ROSIN PARTIALLY DIMERIZED GLYCEROL ESTERINACTIVE INGREDIENTBY866DXY67TOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZTOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-679TOPCARE PAIN RELIEVING 40CT (CAMPHOR MENTHOL METHYL SALICYLATE) PATCH [TOPCO ASSOCIATES LLC]4Legacy NDC, 2 package rows20221217_8d3df8a1-e877-4e6a-b314-c9c5ad0e9dbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchPSN8d3df8a1-e877-4e6a-b314-c9c5ad0e9dbb4
853260camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCD8d3df8a1-e877-4e6a-b314-c9c5ad0e9dbb4
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSY8d3df8a1-e877-4e6a-b314-c9c5ad0e9dbb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-679-403680006794040 POUCH in 1 BOX (36800-679-40) > 1 g in 1 POUCH40 pouch2019-01-090000-00-00NoNoCurrent