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 126 of 316 · 6,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.e810d366-0c32-5b1c-e053-2a95a90a622e2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242b7d0e-82d8-793c-e063-6294a90a4aa32025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.eb744367-f318-e1e2-e053-2a95a90a2cc42025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242faaed-e85a-a1d7-e063-6294a90aea922025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247d6c0e-8f88-faf0-e063-6394a90a10da2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.e8241828-17b2-96c5-e053-2a95a90a12e52025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.1176181b-1331-ba68-e063-6394a90a961a2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247b56ad-4b61-8b6f-e063-6394a90af3b62025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247afcae-855e-3f69-e063-6394a90a42312025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.24306304-4d0d-c5f0-e063-6394a90afad52025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3482855b-de85-a5a7-e063-6294a90a55ae2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483e7e6-b301-136d-e063-6294a90aba182025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483e4fa-883b-fb9c-e063-6394a90adcc42025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483dd31-417b-01ba-e063-6294a90a83a82025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483e998-6122-fb84-e063-6394a90a159f2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.c96e691a-99e1-4cb4-aebf-7444f4a6865f2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.ab1c8e9e-fd8f-473e-8930-625706e8e9d62025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.17073264-ec02-4801-841d-86778debd8c42025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.caee5c88-1907-41c1-987e-5bc544267dca2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.973b70f1-ee59-4dd9-aca3-432d721204ab2025-12-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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