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 183 of 183 · 3,654 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
maximum strength mucus relief severe congestion and coughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESuperValu Inc.,3bb76952-15d8-4a36-a392-60f62b845f092017-09-01WarningsExact identifier
unii: 04JA59TNSJ
Maximum Strength Mucus Relief Cold,Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLSUPERVALU INCbe535a56-1b95-424e-8197-566976ef2efa2017-09-01Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Childrens Tukol Acetaminophen Fever Reducer Pain ReducerACETAMINOPHENGenomma Lab USA, Inc.0540111a-fcde-492d-9ed5-bbd714b2acf02017-04-15WarningsExact identifier
unii: 362O9ITL9D
BRONCOCHEM KIDS ALLERGY CONTROLCHLORPHENIRAMINE MALEATE-DEXTROMETHROPHAN HBRLABORATORIO MAGANCEHM INTERNATIONAL SRL36574266-a6ca-443d-9e1d-85240aabe8a22017-04-10WarningsExact identifier
unii: V1Q0O9OJ9Z
BRONCOCHEM KIDS COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRL523561fb-f6a7-4cde-9be2-bba02e60e2082017-04-06WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
BRONCOCHEM ALLERGY CONTROLCHOLPHENIRAMINE MALEATE-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRLec5a216c-6827-4de3-8683-ff04e726ff6f2017-03-14WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
Acetaminophen CapletsACETAMINOPHENBreeden Brothers, LLC57fff3dc-ba30-4d3d-9362-01df6974f8132017-02-15WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLChain Drug Consortium,LLC47f839b9-ac8a-161c-e054-00144ff8d46c2017-02-07WarningsExact identifier
unii: 362O9ITL9D
Cold MedicineACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLSelder, S.A. de C.V.d2762d9c-e7e7-42b2-a26a-14b2aa0307cb2017-01-25WarningsExact identifier
rxcui: 1046781
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D
SED-MAXACETAMINOPHEN 500 MG WITH CAFFEINE 65MGCommand Brands, LLC4920a0e9-6f88-4df0-8657-77c95a3b96172017-01-19WarningsExact identifier
unii: 362O9ITL9D
Allergy ReliefCHLORPHENIRAMINE MALEATECVS Pharmacy626aa162-f5e3-45c0-b5ac-d70bff255aed2017-01-19WarningsExact identifier
unii: V1Q0O9OJ9Z
AllergyCHLORPHENIRAMINE MALEATEMarc Glassman, Inc.2051247f-ce64-4cf5-b449-9ca14c43ab862016-12-27WarningsExact identifier
unii: V1Q0O9OJ9Z
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRLd0426469-9dd1-4bd1-b81e-69d33187daa22016-12-19WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D
CVS Health Four Actions Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECVS Pharmacy,Inc.c91b5525-6afb-4fea-afcb-9c45780759752016-09-22WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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