FDA.reportPublic FDA data

NDC 55264-112-01 - SINSINPAS AREXLOTION

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55264-112
Requested NDC
55264-112-01
Package NDCs from labels
55264-112-01, 55264-112-02
Manufacturer
Sinsin Pharmaceutical Co., Ltd.
Effective date
2024-01-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SINSINPAS AREX LOTIONSinsin Pharmaceutical Co., Ltd.2024-01-05HUMAN OTC DRUG LABEL

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 11 of 39 · 779 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLH E B21364d47-d026-4b48-8ece-ac44717f65222026-02-11Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLH E B8ba4382d-1a88-4a8d-9d40-c0f38cfd01a52026-02-11Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
Tiger Balm Active Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.2e7638c6-e1ce-4e2f-bd50-52fbce5a138e2026-02-09WarningsExact identifier
unii: LAV5U5022Y
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLRetail Business Services, LLC93e84b24-240e-4f86-98a3-0fed7584c1862026-02-06Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLSalado Sales Inc.c99a8a64-b328-45a3-8ef9-353b40dc20e42026-02-06Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
Care Lix Pain ReliefSALICYLIC ACIDACQUIRED B SCALE LLC65dffffd-ede1-45e2-aa91-bdd5df2df6a62026-02-05WarningsExact identifier
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDiscount Drug Mart2075ed67-bb89-41bc-98bc-a6ab2262bdc72026-02-04Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDiscount Drug Mart53526652-49ac-411b-8906-74f2ad4b64762026-02-04Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
Antiseptic Mouth RinseEUCALYPTOLHARRIS TEETERf96372a9-2fb5-4ba6-8b3e-541c8e6e2cf62026-02-04Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLHarris Teeter9fb0fa91-282a-440d-9d1d-c868a5978ee32026-02-04Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLHARRIS TEETER98728688-32f6-44f1-9cc9-cd72c3a039ad2026-02-04Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLHy-Vee, Inc.4538029b-1ff9-080a-e063-6394a90ac9b72026-02-04Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLLidl US, LLCc3bd0ca6-3f42-423b-92ac-c7f8fc09152b2026-02-04Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOLMarc Glassman, Inc47339eeb-8097-498a-ba4e-a73de477aa182026-02-04Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMarc Glassman, Ince668364b-907b-48fc-9fb2-97619607506b2026-02-04Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMarc Glassman, Incf0ac9715-7d9f-48e9-9371-bb7d8be29c662026-02-04Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLCHEMCO CORPORATION4a05f02e-e882-2cb2-e063-6394a90ad3282026-02-04WarningsExact identifier
unii: LAV5U5022Y
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49e5eeaa-7506-f42a-e063-6294a90a28642026-02-03WarningsExact identifier
unii: 9E8X80D2L0
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCVS Pharmacy, Inc.204025ac-af00-48a0-be8e-7ccc7a36ad452026-02-03Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCVS Pharmacy, Inc.3fceecc1-22b4-43a5-a4e0-d7d5634bcf812026-02-03Warnings, Adverse reactionsExact identifier
unii: LAV5U5022Y

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.