SINSINPAS AREXLOTION

Product NDC
55264-112
Requested package NDC
55264-112-02
11-digit product format
552640112
Labeler code
55264
Product ID
55264-112_ca93e1df-c893-7cc9-e053-2995a90a1033
Type
HUMAN OTC DRUG
Nonproprietary name
L-Menthol
Dosage form
LOTION
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
LEVOMENTHOL; METHYL SALICYLATE; ALPHA-TOCOPHEROL ACETATE
Active strength
60 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55264-11255264-112-02IInactivated by FDA2026-10-12

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
55264-112-01SINSINPAS AREXLOTION1 in 1 BOTTLELOTION12
55264-112-02SINSINPAS AREXLOTION1 in 1 BOXLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-112SINSINPAS AREXLOTION (L-MENTHOL) LOTION [SINSIN PHARMACEUTICAL CO., LTD.]2Legacy NDC, 2 package rows20240106_ca93de41-1aa7-7996-e053-2995a90afe6b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55264-112-02552640112021 BOTTLE in 1 BOX (55264-112-02) > 1 LOTION in 1 BOTTLE (55264-112-01) 1 bottle2021-08-270000-00-00NoNoCurrent