FDA.reportPublic FDA data

NDC 0280-0044 - ANTIFLU

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
0280-0044
Package NDCs from labels
0280-0044-12
Manufacturer
Bayer HealthCare LLC.
Effective date
2025-01-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Antiflu Fim Coated TabletsBayer HealthCare LLC.2025-01-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0044-12ANTIFLU12 in 1 BLISTER PACKTABLET, COATED126
0280-0044-12ANTIFLU1 in 1 CARTONTABLET, COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0044ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC.]62 package rows20250119_12c01d3d-a658-396a-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]1

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 109 of 185 · 3,686 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC96d2e0e7-2de0-4660-9ffd-9edb2ad224d82025-04-18WarningsExact identifier
unii: 04JA59TNSJ
Pain RelieverACETAMINOPHENChain Drug Consortium60d4b392-6ed0-4115-8154-24eaf72504a52025-04-16WarningsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.71c7a627-6ed9-4f49-8cdc-b3228c021e642025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLC23780dab-91d8-434f-9342-f5f1ba0a3c0a2025-04-15WarningsExact identifier
unii: 362O9ITL9D
Premsyn pms Premenstrual Pain ReliefACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATEFocus Consumer Healthcare, LLC5b6f6260-69ae-cfeb-e053-2a91aa0a6b492025-04-14WarningsExact identifier
unii: 362O9ITL9D
BackAid MaxACETAMINOPHEN, PAMABROMKobayashi Healthcare International, Inc.fb9a5647-b7c9-4820-b148-91060e34cb832025-04-14WarningsExact identifier
unii: 362O9ITL9D
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAurolife Pharma, LLCf9fde75d-7def-48fc-a2b0-727f677f60012025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Arthriten Inflammatory Pain FormulaACETAMINOPHEN, ASPIRIN, CAFFEINEKobayashi Healthcare International, Incc280ca89-4fb5-4050-90ee-d706a550a1ef2025-04-11WarningsExact identifier
unii: 362O9ITL9D
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATEBayer HealthCare LLC.ce9e6acb-a38b-4c9b-a7e8-3e1c2a49a3242025-04-10WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENRedpharm drug1535f903-8bd0-c09e-e063-6294a90a4d4d2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and CodeineACETAMINOPHEN AND CODEINERedPharm Drug, Inc.a35b4ba3-43c0-73c8-e053-2a95a90af5b52025-04-09Boxed warning, WarningsExact identifier
unii: 362O9ITL9D
Advil Allergy and Congestion ReliefCHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa6cc97d8-252a-4527-a470-6d9e356342fd2025-04-09WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
Foster and Thrive Pain RelieverACETAMINOPHENStrategic Sourcing Services LLC0a7d82f8-7615-4cef-b245-94b186f3c8fa2025-04-07WarningsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENDirect_Rxe4e27022-581e-ba8c-e053-2a95a90a1ae42025-04-07Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENGland Pharma Limiteddb5d4cf8-762a-4111-971e-91c704bc36432025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHEN 500MGCVS Pharmacy, Inc.1fde6487-6682-99a3-e063-6294a90a36702025-04-04WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN AND IBUPROFENDr. Reddy's Labortories Inc3e65c8a3-498e-1a2a-bb76-18e28ae2c73c2025-04-04WarningsExact identifier
unii: 362O9ITL9D
Nighttime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELSWALGREENS2be0a699-e6ad-ef56-e063-6394a90aaca52025-04-03WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.31d24067-3c25-0f1a-e063-6394a90a9f1d2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepackbdc466c9-d9ae-4293-b7ea-46fb517661c62025-04-01WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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