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 119 of 316 · 6,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Low Dose AspirinASPIRINHy-Vee98ab6fb7-c7e5-45ab-97c3-81d422f8a8432025-12-11WarningsExact identifier
application number: M013
unii: R16CO5Y76E
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma33599f18-5f49-4f22-8a77-a072115763ef2025-12-11WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Sinus Congestion and Pain Relief Non-DrowsyACETAMINOPHEN, PHENYLEPHRINE HCLWinCo Foods, LLCf7e925f4-7da6-4157-a97f-e6a3e399911f2025-12-11WarningsExact identifier
unii: 362O9ITL9D
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEWinCo Foods, LLC860c4e94-1d1a-4f74-a14a-35f86f4523c42025-12-11WarningsExact identifier
unii: 3G6A5W338E
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENRedpharm Drug37451478-b961-873b-e063-6394a90a7b4e2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Cell WellCALCIUM CARBONICA,CALCIUM FLUORATUM,CALCIUM PHOSPHORICUM,CALCIUM SULPHURICUM,FERRUM PHOSPHORICUM,KALIUM MURIATICUM,KALIUM PHOSPHORICUM,KALIUM SULPHURICUM,MAGNESIUM CARBONICA,MAGNESIUM PHOSPHORICUM,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAJoyWell Co LLC592c1f48-21c8-4ff5-8818-046662c9effe2025-12-11WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus Relief Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH645f8075-e33f-4e1a-9249-7368261cdcb92025-12-11WarningsExact identifier
unii: 362O9ITL9D
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA HAIR DESIGN36eb4cd3-778c-362f-e063-6294a90a059c2025-12-11Exact identifier
unii: 15FIX9V2JP
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37630c6c-f768-7b3e-e063-6394a90af5652025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348fcc63-d8e3-90a1-e063-6294a90ade112025-12-11Exact identifier
unii: 15FIX9V2JP
SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique Aesthetics Pllc34a49563-c74b-2fd1-e063-6394a90a6c562025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a52011-b781-75cf-e063-6394a90ae0f42025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a632f5-4458-e335-e063-6394a90a9bcb2025-12-11Exact identifier
unii: 15FIX9V2JP
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3761d74c-0137-0c75-e063-6394a90a3c7d2025-12-11Exact identifier
unii: 15FIX9V2JP
Sun Plus Sun Lip ShieldTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3763a79a-e881-cade-e063-6394a90a49de2025-12-11Exact identifier
unii: 15FIX9V2JP
Stay AwakeCAFFEINEVALU MERCHANDISERS COMPANYb2ae7941-5711-4046-b715-bc77cc04becb2025-12-11WarningsExact identifier
unii: 3G6A5W338E
Low Dose AspirinASPIRINVALU MERCHANDISERS COMPANY746059b3-ed18-4a81-a70e-4d758e048d8e2025-12-11WarningsExact identifier
application number: M013
unii: R16CO5Y76E
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC374e53c6-307f-f8e5-e063-6394a90a07ef2025-12-11Exact identifier
unii: 15FIX9V2JP
Extra Strength Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf8820150-feec-4062-85bb-14525ddf691f2025-12-11WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC373e29f1-d665-a3c4-e063-6294a90a403e2025-12-11Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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