FDA.reportPublic FDA data

SINSINPAS AREXGEL

Product NDC
55264-114
11-digit product format
552640114
Labeler code
55264
Product ID
55264-114_ca93f7ee-25b1-448b-e053-2a95a90a459e
Type
HUMAN OTC DRUG
Nonproprietary name
L-Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Sinsin Pharmaceutical Co., Ltd.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-08-27
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE
Active strength
96 mg/1; mg/1; 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55264-114IInactivated by FDA2026-10-05
excluded packagepackage55264-11455264-114-02IInactivated 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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-114-01SINSINPAS AREXGEL6 in 1 PATCHPATCH63
55264-114-02SINSINPAS AREXGEL1 in 1 POUCHPATCH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-114SINSINPAS AREXGEL (L-MENTHOL) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]3Legacy NDC, 2 package rows20240106_ca91bdca-0004-6617-e053-2a95a90ad7a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2568113camphor 96 MG / levomenthol 76.8 MG / methyl salicylate 57.6 MG Medicated PatchPSNca91bdca-0004-6617-e053-2a95a90ad7a03
2568113camphor 96 MG / levomenthol 76.8 MG / methyl salicylate 57.6 MG Medicated PatchSCDca91bdca-0004-6617-e053-2a95a90ad7a03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55264-114-01552640114016 in 1 PATCHHistorical
55264-114-02552640114021 PATCH in 1 POUCH (55264-114-02) > 6 PATCH in 1 PATCH (55264-114-01) 1 patch2021-08-270000-00-00NoNoCurrent