FDA.reportPublic FDA data

NDC 0280-0045 - Antiflu powder

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
0280-0045
Package NDCs from labels
0280-0045-05
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 Powder PouchesBayer HealthCare LLC.2025-01-17HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0045-05Antiflupowder5 in 1 CARTONPOWDER, FOR SOLUTION57
0280-0045-05Antiflupowder17000 mg in 1 PACKETPOWDER, FOR SOLUTION170007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0045ANTIFLU POWDER (ACETAMINOPHEN, L-PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.]72 package rows20250119_12be94ed-c3d9-5415-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DANTIFLU POWDER (ACETAMINOPHEN, L-PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZANTIFLU POWDER (ACETAMINOPHEN, L-PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJANTIFLU POWDER (ACETAMINOPHEN, L-PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC, CONSUMER CARE]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DANTIFLU POWDER (ACETAMINOPHEN, L-PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UANTIFLU POWDER (ACETAMINOPHEN, L-PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVANTIFLU POWDER (ACETAMINOPHEN, L-PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC, CONSUMER CARE]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RANTIFLU POWDER (ACETAMINOPHEN, L-PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPANTIFLU POWDER (ACETAMINOPHEN, L-PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC, CONSUMER CARE]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTIFLU POWDER (ACETAMINOPHEN, L-PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) POWDER, FOR SOLUTION [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 127 of 196 · 3,903 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bliss GVS HemorrhoidalHARD FAT, PHENYLEPHRINE HCLBliss GVS Pharma Limited88c49f6c-2a48-2dae-e053-2a95a90af20a2024-12-19WarningsExact identifier
unii: 04JA59TNSJ
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
unii: 04JA59TNSJ
DCH Rapid Relief HemorrhoidalLIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labs00eef84c-a72e-3343-e063-6294a90aa4d82024-12-19WarningsExact identifier
unii: 04JA59TNSJ
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
unii: 04JA59TNSJ
Tussnex FM Cold, Flu and Sore ThroatACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company7bddce11-c227-4d95-94c1-6f41ecd7285b2024-12-19WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Childrens Tussnex Multi-symptom coldDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company9028676e-d725-4afe-aa14-72235825aa172024-12-19WarningsExact identifier
unii: 04JA59TNSJ
Tussnex FM Cold and SinusACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company04c6bb6a-d2f8-4322-afba-e240e80901762024-12-19WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENQuality Care Products, LLC53941807-072e-4783-819d-106ea904eda22024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Tussnex FM Severe cough and congestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company387df403-7803-4031-915e-8de9b103a1622024-12-19WarningsExact identifier
unii: 04JA59TNSJ
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENQuality Care Products, LLCe7d36246-9c80-49b6-ad4b-e38c3fd6d0682024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEBryant Ranch Prepack3fe91e9f-4033-4b48-b51b-7eb67d40fa3a2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Sunmark Chest Congestion Relief PE PEGUAIFENESIN/PHENYLEPHRINEStrategic Sourcing Services LLCf94ae469-4c79-4ce9-9a3d-3bdc645be6d92024-12-18WarningsExact identifier
unii: 04JA59TNSJ
Hemorroidal Cooling gelPHENYLEPHRINE, WITCH HAZELTrifecta Pharmaceuticals Usa Llc651c0143-384c-3649-e053-2991aa0a0f282024-12-18WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc50cc6ad-e8a0-47c1-e053-2a95a90a4de62024-12-18WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc59dcb2a-392b-670b-e053-2995a90a96822024-12-18WarningsExact identifier
unii: 04JA59TNSJ
TheraCare HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLVeridian Healthcarefab95657-d257-e671-e053-6294a90a59e02024-12-18WarningsExact identifier
unii: 04JA59TNSJ
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEPreferred Pharmaceuticals Inc.91e50642-d278-47c6-944b-4ed907e87e6b2024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Childrens Metapp DaytimeBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLGuardian Drug Company40565500-944b-47f2-8563-5df05469e4182024-12-18WarningsExact identifier
unii: 04JA59TNSJ
CVS Health Chest Congestion Relief PEGUAIFENESIN/PHENYLEPHRINECVS Pharmacy, Inc.a49020e8-739e-47ec-8141-e866479a3ab32024-12-18WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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