EXOTEN-C

Product NDC
76420-944
11-digit product format
764200944
Labeler code
76420
Product ID
76420-944_733f308e-f01f-4411-b6d9-35356e8b7557
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl salicylate, Menthol, Capsaicin
Dosage form
LOTION
Route
TOPICAL
Labeler
Asclemed USA, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-05-08
Marketing end
0000-00-00
Substance
METHYL SALICYLATE; MENTHOL; CAPSAICIN
Active strength
20 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct76420-944DDiscontinued by firm2026-10-15
excluded packagepackage76420-94476420-944-01DDiscontinued by firm2026-10-15

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 · 24 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 packagepackage76420-944-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76420-944-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76420-944-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76420-944-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76420-944-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76420-944-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76420-944-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76420-944-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76420-944-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76420-944-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76420-944-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76420-944-01557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-944-01GM - Gram76420-94493c9e80d-ec8c-4b76-a040-5021f8ea352c12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CapsaicinACTIVE INGREDIENTS07O44R1ZMEXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
MentholACTIVE INGREDIENTL7T10EIP3AEXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
Methyl salicylateACTIVE INGREDIENTLAV5U5022YEXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
CapsaicinACTIVE MOIETYS07O44R1ZMEXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
MentholACTIVE MOIETYL7T10EIP3AEXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
Methyl salicylateACTIVE MOIETYLAV5U5022YEXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XEXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0EXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZWEXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SEXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
Ethylhexyl PalmitateINACTIVE INGREDIENT2865993309EXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXEXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
METHYLDIBROMO GLUTARONITRILEINACTIVE INGREDIENTYX089CPS05EXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TEXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKEXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2
WaterINACTIVE INGREDIENT059QF0KO0REXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [MEDCHEM MANUFACTURING INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-944-0176420094401113.4 g in 1 BOTTLE (76420-944-01) 113.4 g2012-05-080000-00-00NoNoCurrent