K19 RELIEF

Product NDC
83574-413
11-digit product format
835740413
Labeler code
83574
Product ID
83574-413_2bbc8ed1-176c-27a5-e063-6394a90a38ee
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
K19 LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-10
Substance
MENTHOL
Active strength
12.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct83574-413UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83574-41383574-413-00UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
K19 RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL12.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1606487Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e2e1ca96-1ae8-4c99-b8de-ce26754292f9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83574-413-00K19 RELIEF295 mL in 1 BOTTLE, SPRAYLIQUID2953

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83574-413K19 RELIEF (MENTHOL) LIQUID [K19 LLC]3Current NDC, 1 package rows20250116_e2e1ca96-1ae8-4c99-b8de-ce26754292f9.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 83 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Roll-on Pain ReliefLIDOCAINE HCLAmerisource Bergena0c3adbf-fa35-47c0-9db3-459ce9a106ac2025-08-06WarningsExact identifier
application number: M017
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1606487menthol 1.25 % Topical SprayPSNe2e1ca96-1ae8-4c99-b8de-ce26754292f93
1606487menthol 12.5 MG/ML Topical SpraySCDe2e1ca96-1ae8-4c99-b8de-ce26754292f93
1606487menthol 1.25 % Topical SpraySYe2e1ca96-1ae8-4c99-b8de-ce26754292f93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83574-413-0083574041300295 mL in 1 BOTTLE, SPRAY (83574-413-00) 295 ml2023-07-10NoNoCurrent