FDA.reportPublic FDA data

Zaxs Aches and Pain

Product NDC
82186-162
Requested package NDC
82186-162-01
11-digit product format
821860162
Labeler code
82186
Product ID
82186-162_d025b22f-33d6-76e0-e053-2a95a90a8bf8
Type
HUMAN OTC DRUG
Nonproprietary name
Capsicum, Methyl salicylate, Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Zax Healthcare Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-11-22
Marketing end
0000-00-00
Substance
CAPSICUM; MENTHOL; METHYL SALICYLATE
Active strength
1 mg/g; mg/g; mg/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 packagepackage82186-16282186-162-01IInactivated by FDA2026-10-05

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
82186-162-01Zaxs Aches and Pain120 g in 1 TUBECREAM1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82186-162ZAXS ACHES AND PAIN (CAPSICUM, METHYL SALICYLATE, MENTHOL) CREAM [ZAX HEALTHCARE INC.]2Legacy NDC, 1 package rows20241215_d025b127-003f-30b2-e053-2a95a90a189f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2585453capsicum extract 0.13 % / menthol 5 % / methyl salicylate 10.5 % Topical CreamPSNd025b127-003f-30b2-e053-2a95a90a189f2
2585453Capsicum extract 1.3 MG/ML / menthol 50 MG/ML / methyl salicylate 105 MG/ML Topical CreamSCDd025b127-003f-30b2-e053-2a95a90a189f2
2585453capsicum extract 0.13 % / menthol 5 % / methyl salicylate 10.5 % Topical CreamSYd025b127-003f-30b2-e053-2a95a90a189f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82186-162-0182186016201120 g in 1 TUBE (82186-162-01) 120 g2021-11-220000-00-00NoNoCurrent