Pain Relief Rub

Product NDC
36800-042
11-digit product format
368000042
Labeler code
36800
Product ID
36800-042_9ef393b1-8484-4321-9ad7-c9be0a7bf15e
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor,Menthol, methyl salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Topco Associates LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-09-01
Marketing end
0000-00-00
Substance
MENTHOL; MENTHYL SALICYLATE, (+/-)-; CAMPHOR (NATURAL)
Active strength
10 g/100g; g/100g; g/100g
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 productproduct36800-042IInactivated by FDA2026-10-05
excluded packagepackage36800-04236800-042-04IInactivated 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 · 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 packagepackage36800-042-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-042-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-042-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-042-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-042-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-042-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-042-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-042-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36800-042-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-042-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-042-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-042-04557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage36800-042-048af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage36800-042-04834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage36800-042-041332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage36800-042-04fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage36800-042-0486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage36800-042-04bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage36800-042-048dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage36800-042-04e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage36800-042-049bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage36800-042-04110d247fa046…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
36800-042-042019-11-27C16284748780-19855d018-d490-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-042-04Pain Relief Rub1 in 1 BOXCREAM11
36800-042-04Pain Relief Rub114 g in 1 TUBECREAM1141

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Camphor (Natural)ACTIVE INGREDIENTN20HL7Q941PAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
MENTHOLACTIVE INGREDIENTL7T10EIP3APAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
MENTHYL SALICYLATE, (+/-)-ACTIVE INGREDIENT43XOA705ZDPAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
Camphor (Natural)ACTIVE MOIETYN20HL7Q941PAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
MentholACTIVE MOIETYL7T10EIP3APAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZPAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27EPAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSPAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MPAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-042PAIN RELIEF RUB (CAMPHOR,MENTHOL, METHYL SALICYLATE) CREAM [TOPCO ASSOCIATES LLC]1Legacy NDC, 2 package rows20130901_9e4c7e73-910c-4a75-8570-2d650006ce93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN9e4c7e73-910c-4a75-8570-2d650006ce931
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD9e4c7e73-910c-4a75-8570-2d650006ce931
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY9e4c7e73-910c-4a75-8570-2d650006ce931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
36800-042-04368000042041 in 1 BOXHistorical