FDA.reportPublic FDA data

2-Count HEAT PATCHES

Product NDC
63868-308
Requested package NDC
63868-308-02
11-digit product format
638680308
Labeler code
63868
Product ID
63868-308_c9351a5f-6cc8-4b47-9aa3-5e0cab0b67a0
Type
HUMAN OTC DRUG
Nonproprietary name
CAPSAICIN
Dosage form
PATCH
Route
TOPICAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
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
2020-12-31
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 packagepackage63868-30863868-308-02IInactivated by FDA2026-10-05

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
63868-308-022-Count HEAT PATCHES2 in 1 BOXPATCH21
63868-308-022-Count HEAT PATCHES9 g in 1 PATCHPATCH91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-3082-COUNT HEAT PATCHES (CAPSAICIN) PATCH [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1Legacy NDC, 2 package rows20170915_722f5353-df01-4c4e-b6ce-0daa5f4a3c63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSN722f5353-df01-4c4e-b6ce-0daa5f4a3c631
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD722f5353-df01-4c4e-b6ce-0daa5f4a3c631
1043399capsaicin 0.025 % Medicated PatchSY722f5353-df01-4c4e-b6ce-0daa5f4a3c631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-308-02638680308022 PATCH in 1 BOX (63868-308-02) > 9 g in 1 PATCH2 patch2017-06-010000-00-00NoNoCurrent