FDA.reportPublic FDA data

EXOTEN-C

Product NDC
76420-947
11-digit product format
764200947
Labeler code
76420
Product ID
76420-947_07cec02c-17d3-145d-e063-6294a90a0fb3
Type
HUMAN OTC DRUG
Nonproprietary name
METHYL SALICYLATE, MENTHOL, CAPSAICIN
Dosage form
LOTION
Route
TOPICAL
Labeler
Asclemed USA, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-02-10
Substance
METHYL SALICYLATE; MENTHOL; CAPSAICIN
Active strength
20; 10; .025 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
EXOTEN-C
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE20 g/100g
MENTHOL10 g/100g
CAPSAICIN.025 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1870112Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
76ed37e0-64b5-4abe-a03c-3dc7084a3919Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-947-01EXOTEN-C113.4 g in 1 BOTTLELOTION113.44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-947-01GM - Gram76420-9475b6fad93-42e5-4805-a072-f1bbeed576b612017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-947EXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [ASCLEMED USA, INC.]4Current NDC, Legacy NDC, 1 package rows20231016_76ed37e0-64b5-4abe-a03c-3dc7084a3919.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 82 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Roll-on Menthol Pain Relief GelMENTHOLAmerisource Bergenbd557323-0003-4ee6-b22d-a72d621c7de42025-08-05WarningsExact identifier
application number: M017
Earthmed FS Pain relieving balmMENTHOLEarthmed LLC3ba4e769-fec6-52d9-e063-6394a90a65d42025-08-05WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEHF Acquisition Co LLC, DBA HealthFirst3ba6a5ec-fda2-b2a6-e063-6294a90ac9b62025-08-05WarningsExact identifier
application number: M017
Kocowo Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.3b82989d-7cc3-23d3-e063-6294a90ae2a32025-08-03WarningsExact identifier
application number: M017
Menthol pain relief patchesMENTHOLMenthol pain relief patch3b5fd718-3f86-f7a7-e063-6294a90a8c522025-08-02WarningsExact identifier
application number: M017
Graphene Far Infrared Herbal Pain Relief PatchesCORYDALIS RHIZOMEChangsha Maocheng Trading Co., Ltd3b604a3c-fe91-7096-e063-6394a90afe042025-08-02WarningsExact identifier
application number: M017
Active Recovery Pain ReliefCAMPHOR, MENTHOLCharlotte's Web, Inc.3a9f9ca0-3d8a-796a-e063-6394a90a790c2025-08-01WarningsExact identifier
application number: M017
Active Recovery Pain Relief StickCAMPHOR, MENTHOLCharlottes Web, Inc.3aa037c6-6109-b52e-e063-6394a90a215b2025-08-01WarningsExact identifier
application number: M017
PM Recovery Pain ReliefCAMPHOR, MENTHOLCharlotte's Web, Inc.3aa08859-809d-de8c-e063-6394a90a8e252025-08-01WarningsExact identifier
application number: M017
Wish ultra winter iceMENTHOLLJ Pharmab4c5487c-1314-4d63-96df-077e72e7ee952025-08-01WarningsExact identifier
application number: M017
Rugged Fit Pain Relief Roll OnMENTHOL, METHYL SALICYLATESYSTEM4BOOK LLC39d68734-981c-14d7-e063-6294a90a49192025-08-01WarningsExact identifier
application number: M017
ICY FREEZEMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.28fdb049-b297-4358-9447-7d69ba8797022025-08-01WarningsExact identifier
application number: M017
Cortizone 10 CoolingHYDROCORTISONEChattem, Inc.14d9fce2-9f54-4204-83cb-161de8a303f02025-08-01WarningsExact identifier
application number: M017
Bravado Labs NumbingLIDOCAINE HCLProdigy Media Inc8c43f5b5-b911-4a7a-b2d1-56a09c54b0012025-07-30WarningsExact identifier
application number: M017
Chimera GUARDLIDOCAINE PAIN RELIEFING PATCHHangzhou Rongna Health Technology Co., Ltd.3721c984-1993-6265-e063-6394a90af23f2025-07-29WarningsExact identifier
application number: M017
Chimera GUARDLIDOCAINE PAIN RELIEFING PATCHHangzhou Rongna Health Technology Co., Ltd.3758d625-010f-7441-e063-6394a90a066d2025-07-29WarningsExact identifier
application number: M017
Cold Therapy Roll onCOLD THERAPY ROLL ONAllegiant Health36463acb-7c28-416f-a45f-a93f0be5692b2025-07-29WarningsExact identifier
application number: M017
ProCure Anti ItchCAMPHOR 0.5%Twin Med LLC3afe387c-ef42-215d-e063-6394a90a41b52025-07-28WarningsExact identifier
application number: M017
lidocaine pain relief patchesLIDOCAINEChangsha Maocheng Trading Co., Ltd3afeead3-4f5c-4711-e063-6294a90aacca2025-07-28WarningsExact identifier
application number: M017
SYNC ICESYNC RELIEF ICEiON Pharma, LLC38ce98ce-a7bf-8041-e063-6394a90ae7302025-07-28WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870112capsaicin 0.025 % / menthol 10 % / methyl salcylate 20 % Topical LotionPSN76ed37e0-64b5-4abe-a03c-3dc7084a39194
1870112capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 200 MG/ML Topical LotionSCD76ed37e0-64b5-4abe-a03c-3dc7084a39194
1870112capsaicin 0.025 % / menthol 10 % / methyl salcylate 20 % Topical LotionSY76ed37e0-64b5-4abe-a03c-3dc7084a39194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-947-0176420094701113.4 g in 1 BOTTLE (76420-947-01) 113.4 g2017-02-100000-00-00NoNoCurrent