FDA.reportPublic FDA data

Medicated Pain Relief Patches

Product NDC
63868-124
11-digit product format
638680124
Labeler code
63868
Product ID
63868-124_1289a099-6246-435f-8545-7084a73600e0
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR, MENTHOL, METHYL SALICYLATE
Dosage form
PATCH
Route
TOPICAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-09-01
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
3 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-124IInactivated by FDA2026-07-31
excluded packagepackage63868-12463868-124-20IInactivated by FDA2026-07-31
excluded packagepackage63868-12463868-124-60IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Muscle Rub CreamMUSCLE RUB CREAMPreferred Pharmaceuticals Inc.ea209a4e-acad-413b-8fb9-27e98130bcd62026-07-28WarningsExact identifier
hydrocortisoneHYDROCORTISONEPreferred Pharmaceuticals Inc.12cd35e3-e707-4551-b778-bf615c1a8d322026-05-11WarningsExact identifier
Arthritis Pain Relieving CreamMENTHOL, METHYL SALICYLATEInternational Nature Nutraceuticals, Inc.2c9d070c-bf90-4482-8a6e-c7491cdd34c52025-12-27WarningsExact identifier
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLPreferred Pharmaceuticals Inc.186445d4-ef73-4d34-849d-4661a3eaa43a2025-09-30WarningsExact identifier
TerocinLIDOCAINE, MENTHOLPreferred Pharmaceuticals, Inc.23843354-e242-4a8a-8818-897592d4d9a02025-09-30WarningsExact identifier
Discount Drug Mart Regular Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEDiscount Drug Mart8748c31d-8258-0357-e053-2a95a90a9c222019-04-24WarningsExact identifier
Best Choice Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEValu Merchandisers873591ef-16cb-ab90-e053-2991aa0a865d2019-04-23WarningsExact identifier
Fire OutBENZOCAINE AND MENTHOLRandob Ltd.77ab634e-13d4-4f5f-87c8-73976e65a8422019-04-12WarningsExact identifier
Discount Drug Mart Anti-itchHYDROCORTISONEDISCOUNT DRUG MART, INC.853eee29-6f57-59d4-e053-2991aa0aa6112019-03-29WarningsExact identifier
MEDICATED LIP BALMMENTHOL AND EUCALYPTUSBurt's Bees, Inc.30da3cc5-6140-2dee-e054-00144ff8d46c2018-12-21WarningsExact identifier
Instaflex Pain Relief CreamMENTHOLAdaptive Health, LLC911f5021-a851-444e-8c2a-2be4fa94e8282018-12-21WarningsExact identifier
Fast FreezeCAMPHOR (NATURAL), MENTHOLNatural Essentials Inc.60c94da8-6c00-4544-a9a6-a3e87ebabd682018-10-18WarningsExact identifier
AnalgesicMENTHOLSafetec of America, Inc.a90266d4-1e71-4805-aeca-6f8ed45135bb2018-10-01WarningsExact identifier
COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEFMENTHOLNATURAL ESSENTIALS, INC.9fcc79e6-8176-4ebc-8602-0649b02fab862018-09-27WarningsExact identifier
Capsaicin Pain ReliefCAPSAICINKareway Product, Inc.dce9db37-cd07-44d8-8881-f63a2191964f2018-06-07WarningsExact identifier
Pure-AidCAMPHOR, MENTHOL, METHYL SALICYLATEKareway Product, Inc.6def9da7-e118-fd5c-e053-2991aa0a65d22018-06-05WarningsExact identifier
SoundbodyLIDOCAINE, MENTHOLKareway Product, Inc.6c83ec36-3e3d-07a9-e053-2a91aa0ac54c2018-05-18WarningsExact identifier
Avedana Cool Hot IceMENTHOLUnipack, Inc.619c8e3f-0cad-4eb1-8dbb-632f3db74ba32018-05-01WarningsExact identifier
SunBurnt PLUS Pain ReliefLIDOCAINE HYDROCHLORIDEWelmedix LLC dba Welmedix Consumer Healthcare6363c695-f801-407d-a4e1-b0d9cfa0a2732018-03-13WarningsExact identifier
Pure-AidLIDOCAINE, MENTHOLKareway Product, Inc.6679cada-f083-26e8-e053-2a91aa0adcc52018-03-02WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Avoid contact with eyes and mucous membranes • If conditions worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. • Do not apply to wounds or damaged skin. • Do not apply bandage tightly. • Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin. • Discontinue use if excessive irritation of skin develops. • If pregnant or breast feeding, ask a health professional before use. • A temporary burning sensation may occur upon application, but generally disappears in a few days.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-124-202025-01-30C16284748780-12cef2736-8ca1-d83d-e063-dadaa90ab31fQUALITY CHOICE Medicated Pain Relief Patches
63868-124-602025-01-30C16284748780-12cef2736-8ca1-d83d-e063-dadaa90ab31fQUALITY CHOICE Medicated Pain Relief Patches

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-124-20Medicated Pain Relief Patches20 in 1 BOXPATCH202
63868-124-20Medicated Pain Relief Patches9 g in 1 PATCHPATCH92
63868-124-60Medicated Pain Relief Patches60 in 1 BOXPATCH602
63868-124-60Medicated Pain Relief Patches9 g in 1 PATCHPATCH92

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-124-60EA - Each63868-1241e3b001c-8984-4e2d-870c-65ef47d595fd12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-124MEDICATED PAIN RELIEF PATCHES (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2Legacy NDC, 4 package rows20200225_08bf26f5-8fbd-44b9-9f79-5044ba71eb70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSN08bf26f5-8fbd-44b9-9f79-5044ba71eb702
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCD08bf26f5-8fbd-44b9-9f79-5044ba71eb702
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSY08bf26f5-8fbd-44b9-9f79-5044ba71eb702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-124-206386801242020 PATCH in 1 BOX (63868-124-20) > 9 g in 1 PATCH20 patch2017-09-010000-00-00NoNoCurrent
63868-124-606386801246060 PATCH in 1 BOX (63868-124-60) > 9 g in 1 PATCH60 patch2017-09-010000-00-00NoNoCurrent