FDA.reportPublic FDA data

SINSINPAS HOT LARGE

Product NDC
55264-110
Requested package NDC
55264-110-01
11-digit product format
552640110
Labeler code
55264
Product ID
55264-110_c5f0713f-a3ff-3fc8-e053-2a95a90a50a1
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
Sinsin Pharmaceutical Co., Ltd.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-06-29
Marketing end
0000-00-00
Substance
CAPSAICIN
Active strength
30 mg/1
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 packagepackage55264-11055264-110-01IInactivated 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55264-110-012026-01-29C16284748780-149896155-a4f6-586f-e063-e6dba90add90SINSINPAS CAPSAICIN HOT PATCH LARGE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-110-01SINSINPAS HOT LARGE3 in 1 PATCHPATCH32
55264-110-01SINSINPAS HOT LARGE1 in 1 POUCHPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-110SINSINPAS HOT LARGE (CAPSAICIN) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2Legacy NDC, 2 package rows20240106_c5f08d1b-3b56-535a-e053-2995a90afa65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSNc5f08d1b-3b56-535a-e053-2995a90afa652
1043399capsaicin 0.00025 MG/MG Medicated PatchSCDc5f08d1b-3b56-535a-e053-2995a90afa652
1043399capsaicin 0.025 % Medicated PatchSYc5f08d1b-3b56-535a-e053-2995a90afa652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55264-110-01552640110011 PATCH in 1 POUCH (55264-110-01) > 3 PATCH in 1 PATCH1 patch2021-06-290000-00-00NoNoCurrent