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 159 of 184 · 3,665 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Pain and Fever	ACETAMINOPHEN	WALGREENS	0b1d086f-7be1-5072-e063-6394a90a11e6	2024-04-10	Warnings	Exact identifier unii: 362O9ITL9D
Dye Free Infants Pain and Fever	ACETAMINOPHEN	WALGREENS	0b1d88d8-56ff-9e9d-e063-6394a90a015c	2024-04-09	Warnings	Exact identifier unii: 362O9ITL9D
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	H E B	4d572228-3141-4539-9c3d-2fd06e94eee3	2024-04-09	Warnings	Exact identifier unii: 362O9ITL9D
Daytime Cold and Flu Non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	9b0648ac-0ce3-4eaa-8977-26ae864f034d	2024-04-09	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D
FLONASE Headache and Allergy Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Haleon US Holdings LLC	282c103c-3888-4a35-a5b1-d492ed6892c1	2024-04-08	Warnings	Exact identifier rxcui: 1046781 unii: 04JA59TNSJ unii: V1Q0O9OJ9Z unii: 362O9ITL9D
Robitussin Direct Sore Throat Pain	ACETAMINOPHEN	Haleon US Holdings LLC	1b512078-24c3-4b80-8f2c-d6824d367f25	2024-04-08	Warnings	Exact identifier unii: 362O9ITL9D
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	4da8a7bd-0d2e-452c-afb5-fed4e230a9bd	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	12ace982-bd47-49b0-ba1b-e0a29d42f1d6	2024-04-08	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	bd19b1f2-d9d3-4dab-8181-605f769ab62f	2024-04-08	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D
Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	9f533092-060c-4379-9a77-ecfea8aa46e1	2024-04-08	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	89360fa8-014d-4da8-bb1c-197e3aa52256	2024-04-06	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D
Robitussin Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	66360295-f364-479a-8b49-c12b21918279	2024-04-06	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D
Robitussin Peak Cold Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	8c0a2424-e8ac-d91c-b46d-a5ee29f91936	2024-04-06	Warnings	Exact identifier unii: 04JA59TNSJ
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	e7cf7c5d-5c9a-4201-9e30-1cd616071855	2024-04-06	Warnings	Exact identifier unii: 362O9ITL9D
Preparation H Cooling Gel	PHENYLEPHRINE HCL, WITCH HAZEL	Haleon US Holdings LLC	cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4	2024-04-05	Warnings	Exact identifier unii: 04JA59TNSJ
PREPARATION H Maximum Strength	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	Haleon US Holdings LLC	7cc03d2e-e708-589a-d9bb-58ebbda989c0	2024-04-05	Warnings	Exact identifier unii: 04JA59TNSJ
Theraflu Severe Cold Relief Daytime Honey Ginger	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	44404c6a-8031-4f4b-a48e-3739a11a0d2c	2024-04-05	Warnings	Exact identifier unii: 362O9ITL9D
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	1b5ff867-5442-4cf8-bd1e-530093cc88f8	2024-04-05	Warnings	Exact identifier unii: 362O9ITL9D
Activcin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	OPMX LLC.	e06a4d72-cc8d-fd9d-e053-2995a90a7a76	2024-04-05	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D
Coldtac Plus Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	OPMX LLC.	ff5ce5c6-a03f-2ad3-e053-6394a90a99f6	2024-04-05	Warnings	Exact identifier unii: 04JA59TNSJ unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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