FDA.reportPublic FDA data

MEDI-SULTING TOPICAL PAIN RELIEF

Product NDC
63187-067
11-digit product format
631870067
Labeler code
63187
Product ID
63187-067_190ec4f5-eac7-45b0-b70a-d8d64a146264
Type
HUMAN OTC DRUG
Nonproprietary name
METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE
Dosage form
PATCH
Route
TOPICAL
Labeler
Proficient Rx LP
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-08-18
Marketing end
0000-00-00
Substance
METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAPSAICIN; LIDOCAINE
Active strength
20 g/100g; 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 productproduct63187-067DDiscontinued by firm2026-11-13
excluded packagepackage63187-06763187-067-30DDiscontinued by firm2026-11-13

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
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct63187-067IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63187-06763187-067-30IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…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
63187-067-302019-12-06C16284748780-19855e2a2-3b58-60a7-e053-dbdaa90a05bd4c5c0ed8-fe43-4693-83f3-25b6c16b74c6
63187-067-302019-11-27C16284748780-19855e2a2-3b58-60a7-e053-dbdaa90a05bd4c5c0ed8-fe43-4693-83f3-25b6c16b74c6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-067-30EA - Each63187-067cb9a3236-a391-462c-b524-271c0906ee8c12016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
LIDOCAINEACTIVE INGREDIENT98PI200987MEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
CAPSAICINACTIVE MOIETYS07O44R1ZMMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
LIDOCAINEACTIVE MOIETY98PI200987MEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
MENTHOLACTIVE MOIETYL7T10EIP3AMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
ACRYLIC ACIDINACTIVE INGREDIENTJ94PBK7X8SMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0MEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
ETHYLHEXYL ACETATEINACTIVE INGREDIENT2C7K8OA8SBMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
METHYL ACRYLATEINACTIVE INGREDIENTWC487PR91HMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
NONOXYNOL-30INACTIVE INGREDIENTJJX07DG188MEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
POLYACRYLIC ACID (800000 MW)INACTIVE INGREDIENTD0I6NSZ87UMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2JMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5AMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RMEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-067MEDI-SULTING TOPICAL PAIN RELIEF (METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE) PATCH [PROFICIENT RX LP]3Legacy NDC20240131_4c5c0ed8-fe43-4693-83f3-25b6c16b74c6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-067-306318700673030 PATCH in 1 BOX (63187-067-30) > 10 g in 1 PATCH30 patch2014-06-010000-00-00NoNoCurrent