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
Label	Manufacturer	Effective date	Type
Antiflu Fim Coated Tablets	Bayer HealthCare LLC.	2025-01-17	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0280-0044-12	ANTIFLU	12 in 1 BLISTER PACK	TABLET, COATED	12		6
0280-0044-12	ANTIFLU	1 in 1 CARTON	TABLET, COATED	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0280-0044	ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC.]	6	2 package rows	20250119_12c01d3d-a658-396a-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
MAGNESIUM SILICATE	INACTIVE INGREDIENT	9B9691B2N9	ANTIFLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) TABLET, COATED [BAYER HEALTHCARE LLC, CONSUMER CARE]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ANTIFLU (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 160 of 184 · 3,665 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desresfriol-DX Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	OPMX LLC.	ff5e0e0f-bfd2-b02b-e053-6394a90afe8a	2024-04-05	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	0faa3592-4d56-4645-9a0e-066e0bdfebb6	2024-04-05	Warnings	Exact identifier unii: 362O9ITL9D
Acetaminophen	ACETAMINOPHEN TABLET EXTENDED RELEASE	Bryant Ranch Prepack	61ea1796-b9c7-4cb9-9a36-60943f884875	2024-04-05	Warnings	Exact identifier unii: 362O9ITL9D
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	Bryant Ranch Prepack	215e2a6f-ec32-4836-8fad-22c8b40ba1f1	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Pain Relief Childrens Dye Free	ACETAMINOPHEN	H E B	3f9beeeb-5e27-4b81-a647-20e65f0e9fc9	2024-04-03	Warnings	Exact identifier unii: 362O9ITL9D
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	e9dffed5-d615-4e63-9860-c0f6f23848a1	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Childrens Pain Relief	ACETAMINOPHEN	H E B	a0c0277e-50aa-4328-8f93-ab20c6176b2b	2024-04-03	Warnings	Exact identifier unii: 362O9ITL9D
DAYTIME COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Advanced Rx LLC	38299cf3-e884-4676-8cc4-6dd64e7d023c	2024-03-30	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D
NIGHTTIME COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Advanced Rx LLC	d1542362-19c5-4470-89e8-87d26e2ca8ed	2024-03-30	Warnings	Exact identifier unii: 362O9ITL9D
Dual Action Pain Relief	DUAL ACTION PAIN RELIEF	Allegiant Health	fb4fc347-0f90-429f-9ca8-903e736f5496	2024-03-29	Warnings	Exact identifier unii: 362O9ITL9D
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	c8d65aab-d6ae-bc69-e053-2a95a90a7b5e	2024-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
ANTIGRIP Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Pharmadel LLC	12de30fd-95b6-f16d-e063-6294a90aeba2	2024-03-27	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D
Signature Care Migraine Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Safeway	66695667-97a3-4329-8ce0-0fffa8628951	2024-03-27	Warnings	Exact identifier unii: 362O9ITL9D
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	0044c53c-11dd-41a9-a5d9-622dd8b1c144	2024-03-27	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Family Dollar (FAMILY WELLNESS)	650cb15e-c448-4df3-b0f8-4398be05d841	2024-03-27	Warnings	Exact identifier unii: 362O9ITL9D
rugby infants acetaminophen	ACETAMINOPHEN	Rugby Laboratories	8aa9ac68-ca61-4163-a876-52034138c1ea	2024-03-25	Warnings	Exact identifier unii: 362O9ITL9D
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	08a18481-f029-f01f-e063-6294a90aac65	2024-03-21	Warnings	Exact identifier unii: 362O9ITL9D
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	0d106fa2-2a77-deb2-e063-6394a90a2dac	2024-03-21	Warnings	Exact identifier unii: 362O9ITL9D
Tussin CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Best Choice (Valu Merchandisers Company)	1b7b5811-722e-4c4a-844d-c05fa5cfb2e5	2024-03-21	Warnings	Exact identifier unii: 04JA59TNSJ
Acetaminophen	ACETAMINOPHEN TABLET EXTENDED RELEASE	TIME CAP LABORATORIES, INC.	cd4d0ad4-7206-94c8-e053-2a95a90aaa14	2024-03-19	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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