EXOTEN-C

Product NDC
76420-944
Requested package NDC
76420-944-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
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 · 12 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…

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