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 125 of 185 · 3,686 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC3d068d30-9a00-49d7-bbe9-d6b53c19e86d2024-12-02WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENAAA Pharmaceutical, Inc.2d98e390-4f2a-41cc-b307-3d2f6a3700dd2024-12-02WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.409b5fcd-5880-4dda-85d8-26aeceb4f8ab2024-12-02WarningsExact identifier
unii: 362O9ITL9D
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEAAA Pharmaceutical, Inc.73d4fc82-8508-44f8-83ca-9f32c5cd847b2024-12-02WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.19898135-0f7b-45a5-a672-14c49fd210772024-12-02WarningsExact identifier
rxcui: 1046781
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D
NOTTS - Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLCe6754f62-e3b2-773f-e053-2a95a90ad36a2024-12-02WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAAA Pharmaceutical, Inc.a242e005-0330-4afb-83b8-13c7d56f5c6d2024-12-02WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.a891896d-c9fa-4448-915a-e6b531157d222024-12-02WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENSAFEWAYd2d15e06-e9eb-3d2b-e053-2995a90a1cec2024-12-02WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Regular StrengthACETAMINOPHENTopCo Associates LLCc2d33352-431c-4683-a4fa-a54437e7b8d22024-12-02WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENTopCo Associates LLCbdb01b3e-ad34-4003-9b9a-e83a2c0e90bb2024-12-02WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCVS Pharmacy, Incc4473ee6-4e01-1ec2-e053-2995a90ac5132024-12-02WarningsExact identifier
unii: 362O9ITL9D
Childrens Chewable AcetaminophenACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP22f63d62-c941-5b8f-e063-6394a90aeecd2024-11-28WarningsExact identifier
unii: 362O9ITL9D
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a7b6318-b7d6-31b1-e053-2991aa0abf252024-11-28WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLINGLES MARKETS, INC.27fd288e-c07a-617f-e063-6394a90a17a42024-11-28WarningsExact identifier
unii: 362O9ITL9D
EXCEDRIN MIGRAINEACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINEJones Healthcare Group - Packaging Services, Incc4168e4d-3dfc-4e51-a32e-14704cb59c662024-11-27WarningsExact identifier
unii: 362O9ITL9D
Severe Sinus Congestion Allergy and Cough FormulaACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC36a4ec1f-50c3-4d61-ada9-987ccad3563c2024-11-26WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
First Aid Only Extra-Strength Non-AspirinACETAMINOPHENAcme United Corporation6891d57a-10a6-53de-e053-2a91aa0ac7c22024-11-26WarningsExact identifier
unii: 362O9ITL9D
BRONCOCHEM COLD AND FLU CAPLETSACETAMINOPHEN-DEXTROMETHORPHAN HBR-PHENYLEPHRINE HCL-CHLORPHENIRAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f62024-11-26WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D
Alka-Seltzer Plus Cold and Flu, CVPCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLETLil' Drug Store Products, Inc.e7a27773-69d6-9e07-e053-2a95a90af8ea2024-11-25WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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