FDA.reportPublic FDA data

NDC 52389-237-01 - Arthriten Inflammatory Pain Formula

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
52389-237
Requested NDC
52389-237-01
Package NDCs from labels
52389-237-01, 52389-237-28
Manufacturer
Kobayashi Healthcare International, Inc | Kobayashi America Manufacturing, LLC
Effective date
2025-04-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Arthriten Inflammatory Pain FormulaKobayashi Healthcare International, Inc | Kobayashi America Manufacturing, LLC2025-04-11HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-237-01ArthritenInflammatory Pain Formula28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2813
52389-237-28ArthritenInflammatory Pain Formula1 in 1 CARTONTABLET, FILM COATED113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-237ARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC]13Current NDC, Legacy NDC, 2 package rows20250416_c280ca89-4fb5-4050-90ee-d706a550a1ef.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
AspirinACTIVE INGREDIENTR16CO5Y76EARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
CaffeineACTIVE INGREDIENT3G6A5W338EARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
AcetaminophenACTIVE MOIETY362O9ITL9DARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
AspirinACTIVE MOIETYR16CO5Y76EARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
CaffeineACTIVE MOIETY3G6A5W338EARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
HypromellosesINACTIVE INGREDIENT3NXW29V3WOARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
PolydextroseINACTIVE INGREDIENTVH2XOU12IEARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
stearic acidINACTIVE INGREDIENT4ELV7Z65APARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
talcINACTIVE INGREDIENT7SEV7J4R1UARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPARTHRITEN INFLAMMATORY PAIN FORMULA (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]5

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 301 of 307 · 6,135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PEDOXAN ExtractCITRUS UNSHIU PEEL, SAPOSHNIKOVIA ROOT, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEI World Pharmaceutical Co., Ltd.af69d604-180c-702f-e053-2a95a90a2ae42020-09-16WarningsExact identifier
unii: 362O9ITL9D
MaekMunDong Tang ExtractJUJUBE, ACETAMINOPHEN, CHLORHENIRAMINE MALEATEI World Pharmaceutical Co., Ltd.af640819-1187-3254-e053-2995a90a29572020-09-15WarningsExact identifier
unii: 362O9ITL9D
SupremeABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEABOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE72c4679b-aa97-4888-9178-581d0f99c0b62020-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
AcetaminophenACETAMINOPHENSandoz Inc3b4ab1cf-8642-44f5-b3a2-3f1f7c620ce92020-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Butalbital and AcetaminophenBUTALBITAL AND ACETAMINOPHEN TABLETSOceanside Pharmaceuticalsd2213ffd-18f6-45f5-9af7-690a977562c42020-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHEN 500 MGAllegiant Health8e60b78e-ef3c-4d44-b8d4-37cb8608a5c72020-03-13WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Caffeine and Sodium BenzoateCAFFEINE AND SODIUM BENZOATEAmerican Regent, Inc.b2c6b352-f837-4903-8e4c-fb0a2b20bb602019-12-06Exact identifier
unii: 3G6A5W338E
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.73dea6de-20cb-4cef-b987-3ab2c64e5edb2019-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPdd4dbe5b-8d07-4a96-a78d-2f20da761dad2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP6253b3ae-bb52-4532-8d1f-756c0b1577c72019-11-01Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP0233de1c-466b-4842-8604-6d879aa36a4b2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool VanillaOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASd701c221-9f68-47ff-b766-2f4f1998649f2019-10-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 AmberOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS7f5e6872-4d26-410e-8afe-16a016f9a3992019-10-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm IvoryOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS1124ba7d-a328-409b-8c88-e74bb3e501f52019-10-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 HoneyOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SAS9c407dc7-fcde-4660-9a06-57bd8a6b867d2019-10-08WarningsExact identifier
unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 ChestnutOCTINOXATE, TITANIUM DIOIXIDE, OCTISALATEBCM Cosmetique SASf07e8bb2-30ae-4337-ad60-84f55f2ff3542019-10-08WarningsExact identifier
unii: 15FIX9V2JP
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPdf97ea5a-51df-453b-b1b4-edc74c718ee72019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINELannett Company, Inc.c1107153-494b-4068-8500-96bc241187a52019-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEWestminster Pharmaceuticals, LLC1c0511d0-fe63-45c6-8da2-6ceeb56edb172019-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENAphena Pharma Solutions - Tennessee, LLC89134c3e-ec5b-4a57-952a-98d6c6cff7c22019-02-26WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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