FDA.reportPublic FDA data

Max Revive Plaster

Product NDC
82198-0001
Requested package NDC
82198-0001-1
11-digit product format
821980001
Labeler code
82198
Product ID
82198-0001_ce48f4fe-912f-4bd2-e053-2995a90a6162
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
Big 5 Nutrition LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-10-11
Marketing end
0000-00-00
Substance
MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
0 g/g; g/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage82198-000182198-0001-1DDiscontinued by firm2026-11-02

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82198-0001-1Max Revive Plaster2.3 g in 1 PATCHPATCH2.32
82198-0001-1Max Revive Plaster3 in 1 BAGPATCH32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82198-0001MAX REVIVE PLASTER (MENTHOL, METHYL SALICYLATE) PATCH [BIG 5 NUTRITION LLC]2Legacy NDC, 2 package rows20231122_ce48f4fe-912e-4bd2-e053-2995a90a6162.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874174menthol 4 % / methyl salicylate 1 % Medicated PatchPSNce48f4fe-912e-4bd2-e053-2995a90a61622
1874174menthol 0.04 MG/MG / methyl salicylate 0.01 MG/MG Medicated PatchSCDce48f4fe-912e-4bd2-e053-2995a90a61622
1874174menthol 4 % / methyl salicylate 1 % Medicated PatchSYce48f4fe-912e-4bd2-e053-2995a90a61622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82198-0001-1821980001013 PATCH in 1 BAG (82198-0001-1) > 2.3 g in 1 PATCH3 patch2021-10-110000-00-00NoNoCurrent