FDA.reportPublic FDA data

2-Count HEAT PATCHES

Product NDC
53943-904
Requested package NDC
53943-904-02
11-digit product format
539430904
Labeler code
53943
Product ID
53943-904_f2050298-8bf8-2d70-e053-2a95a90a4fb8
Type
HUMAN OTC DRUG
Nonproprietary name
CAPSAICIN
Dosage form
PATCH
Route
TOPICAL
Labeler
Discount Drug Mart, Inc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-06-01
Marketing end
0000-00-00
Substance
CAPSAICIN
Active strength
0 g/100g
NDC exclude flag
No
Listing certified through
2024-12-31
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 packagepackage53943-90453943-904-02IInactivated by FDA2026-10-16

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-904-022-Count HEAT PATCHES9 g in 1 PATCHPATCH94
53943-904-022-Count HEAT PATCHES2 in 1 BOXPATCH24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-9042-COUNT HEAT PATCHES (CAPSAICIN) PATCH [DISCOUNT DRUG MART, INC]4Legacy NDC, 2 package rows20241222_c87def72-a476-4be6-a36b-62364b4c3c79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSNc87def72-a476-4be6-a36b-62364b4c3c794
1043399capsaicin 0.00025 MG/MG Medicated PatchSCDc87def72-a476-4be6-a36b-62364b4c3c794
1043399capsaicin 0.025 % Medicated PatchSYc87def72-a476-4be6-a36b-62364b4c3c794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-904-02539430904022 PATCH in 1 BOX (53943-904-02) > 9 g in 1 PATCH2 patch2017-06-010000-00-00NoNoCurrent