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 35 of 185 · 3,686 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate pain relief pmACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.85129749-c1a7-4c4a-933f-c3c4768e2cdd2026-05-05WarningsExact identifier
unii: 362O9ITL9D
Sinus Congestion and Pain Daytime Non-DrowsyACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEH E Be9dd2d7b-0a19-4a42-b51e-b9914f02406e2026-05-04WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICEf3feca65-adc1-469f-bef6-12c860599abe2026-05-04WarningsExact identifier
unii: 362O9ITL9D
Sanatos NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC3dd3ed85-0c0a-8390-e063-6294a90a668e2026-05-04WarningsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENKVK-Tech, Inc.f9cf218c-af5e-4249-aa3b-a8555ed022782026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Good Sense Daytime non drowsy cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company0122cd34-5817-4af5-a51a-8d176dee0a302026-05-04WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafewayd810a6a9-6112-4e9d-a396-36084b7e110e2026-05-04WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENStrategic Sourcing Services LLC4dda3534-4e83-447b-be75-33dadce06c472026-05-04WarningsExact identifier
unii: 362O9ITL9D
Tylenol PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDESavings Distributors LLC8ed9a9f0-d37e-5c10-e053-2a95a90a559f2026-05-01WarningsExact identifier
unii: 362O9ITL9D
Tylenol Extra StrengthACETAMINOPHENSavings Distributors LLC8ed90757-833e-f4d9-e053-2995a90a29db2026-05-01WarningsExact identifier
unii: 362O9ITL9D
Tylenol Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8e87f8de-f83e-0f8d-e053-2a95a90a8d6a2026-05-01WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8eecb3f0-eb5e-e847-e053-2995a90a86bd2026-05-01WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP6980bfc5-15e4-48ec-9346-6f09f8f789002026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Sinus Pressure and Congestion Relief PE Maximum StrengthPHENYLEPHRINE HCLRite Aid Corporationfccea3c5-42af-4939-82bc-d9409b75f91f2026-05-01WarningsExact identifier
unii: 04JA59TNSJ
Night Time Cold and Flu originalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLCcfaf4b3d-fab4-424d-adbe-aaedca58912d2026-04-30WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLC21e7d323-5b78-43aa-b0fc-34c2a864ab9a2026-04-30WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENSpecGx LLCd621b526-4d9a-48a9-9a3e-d29d6aea2f312026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E Bec0b5f4b-b58c-445f-acf1-c7ce301bba642026-04-30WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Panadol Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC341761b9-f0be-f816-e063-6394a90a5e632026-04-29WarningsExact identifier
unii: 362O9ITL9D
Panadol Cold and Flu NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3417993d-8e3c-23d6-e063-6394a90a7d502026-04-29WarningsExact identifier
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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