FDA.reportPublic FDA data

Max Revive Plaster

Product NDC
82198-0002
Requested package NDC
82198-0002-1
11-digit product format
821980002
Labeler code
82198
Product ID
82198-0002_ce4a0aca-ef71-3a05-e053-2a95a90ae99e
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 packagepackage82198-000282198-0002-1DDiscontinued 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
82198-0002-1Max Revive Plaster1.7 g in 1 PATCHPATCH1.72
82198-0002-1Max Revive Plaster5 in 1 BAGPATCH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82198-0002MAX REVIVE PLASTER (MENTHOL, METHYL SALICYLATE) PATCH [BIG 5 NUTRITION LLC]2Legacy NDC, 2 package rows20231122_ce4a0aca-ef70-3a05-e053-2a95a90ae99e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874174menthol 4 % / methyl salicylate 1 % Medicated PatchPSNce4a0aca-ef70-3a05-e053-2a95a90ae99e2
1874174menthol 0.04 MG/MG / methyl salicylate 0.01 MG/MG Medicated PatchSCDce4a0aca-ef70-3a05-e053-2a95a90ae99e2
1874174menthol 4 % / methyl salicylate 1 % Medicated PatchSYce4a0aca-ef70-3a05-e053-2a95a90ae99e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82198-0002-1821980002015 PATCH in 1 BAG (82198-0002-1) > 1.7 g in 1 PATCH5 patch2021-10-110000-00-00NoNoCurrent