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 137 of 196 · 3,903 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength TYLENOL Cold Plus Flu Multi-Action DayACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC7d3266dc-879a-4d28-b8ea-74d238c3020a2024-11-07WarningsExact identifier
unii: 362O9ITL9D
TYLENOL 8 HR MUSCLE ACHES AND PAINACETAMINOPHENKenvue Brands LLC037ec598-cba6-dbb6-e063-6394a90ac42c2024-11-07WarningsExact identifier
unii: 362O9ITL9D
Tylenol Cold Plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCce43e5c2-fe96-4462-882c-d7479318b33d2024-11-07WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
TYLENOL SINUS PLUS HEADACHE DAYACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCe608d214-cc46-4a24-ac85-1040e36e74032024-11-07WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCdd87e342-b0cb-4111-9f15-415dbcda4b772024-11-07WarningsExact identifier
unii: 362O9ITL9D
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC0c5fdda8-5049-46de-e063-6294a90a592b2024-11-07WarningsExact identifier
unii: 362O9ITL9D
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC46ddbfde-54ab-4373-b832-b9c0620b1e9d2024-11-07WarningsExact identifier
unii: 362O9ITL9D
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLCe83f7911-22b4-4ffc-8f49-68f6acd2ebf52024-11-07WarningsExact identifier
unii: 362O9ITL9D
Extra Strength TYLENOL Severe Cough Plus Sore Throat NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.Kenvue Brands LLCf81d924e-10e9-0e9d-e053-6294a90a2ddf2024-11-07WarningsExact identifier
unii: 362O9ITL9D
Childrens TYLENOL COLD Plus FLUACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8b516736-86ac-47cb-a0ec-038d4c3a00202024-11-07WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D
Tylenol 8HRACETAMINOPHENKenvue Brands LLC5d7d1300-bcb8-466a-880b-310b360ee1322024-11-07WarningsExact identifier
unii: 362O9ITL9D
Tylenol Cold plus Flu plus Cough NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCe85e5eb9-3ecf-4784-999e-111e38e306f52024-11-07WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
TYLENOL COLD PLUS FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCef8a846d-4b29-4fd8-a683-fada04d0a2b92024-11-07WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC333f6231-3778-4c1f-9558-2afddca22c862024-11-07WarningsExact identifier
unii: 362O9ITL9D
Childrens TYLENOL COLD Plus FLUACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC9761c807-75a1-4498-a8c6-1f2b1c9ffde62024-11-07WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
unii: 362O9ITL9D
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC34247a3b-0846-4086-becd-76e630b3b7212024-11-07WarningsExact identifier
unii: 362O9ITL9D
TYLENOL Cold Plus Mucus SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC24ac94e8-b223-424e-bcd2-9c027c8ff9ed2024-11-07WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCa51c2deb-c703-4dc8-9255-8ac9fe6351702024-11-07WarningsExact identifier
unii: 362O9ITL9D
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCce0a1fbc-7345-462b-b0da-c7149bdc288c2024-11-07WarningsExact identifier
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC015a6179-bacb-452d-b594-4de628ddc11d2024-11-07WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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