SINSINPAS AREX INSTANT PAIN RELIEF SMALL

Product NDC
55264-109
Requested package NDC
55264-109-01
11-digit product format
552640109
Labeler code
55264
Product ID
55264-109_c5ef6108-c190-2cf2-e053-2995a90a6f13
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Mentha Oil, Methyl Salicylate, Zinc Oxide
Dosage form
PATCH
Route
CUTANEOUS; TOPICAL; TRANSDERMAL
Labeler
Sinsin Pharmaceutical Co., Ltd.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-06-29
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); PEPPERMINT OIL; LEVOMENTHOL; METHYL SALICYLATE; ZINC OXIDE
Active strength
34 mg/1; mg/1; 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 packagepackage55264-10955264-109-01IInactivated by FDA2026-08-03

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-109-01SINSINPAS AREX INSTANT PAIN RELIEF SMALL1 in 1 POUCHPATCH12
55264-109-01SINSINPAS AREX INSTANT PAIN RELIEF SMALL10 in 1 PATCHPATCH102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-109SINSINPAS AREX INSTANT PAIN RELIEF SMALL (CAMPHOR, MENTHOL, MENTHA OIL, METHYL SALICYLATE, ZINC OXIDE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]2Legacy NDC, 2 package rows20240106_c5ef616b-76c9-347f-e053-2a95a90a1dfa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55264-109-01552640109011 PATCH in 1 POUCH (55264-109-01) > 10 PATCH in 1 PATCH1 patch2021-06-290000-00-00NoNoCurrent