Extra Strength TYLENOL Cold Plus Flu Multi-Action

Product NDC: 50580-344
11-digit product format: 505800344
Labeler code: 50580
Product ID: 50580-344_21702ebc-459b-7f5a-e063-6294a90ad432
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan Hydrobromide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-06-21
Substance: DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 15; 500; 30 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Extra Strength TYLENOL Cold Plus Flu Multi-Action
Brand name suffix: Day
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/1
ACETAMINOPHEN	500 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
362O9ITL9D	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1250743	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7d3266dc-879a-4d28-b8ea-74d238c3020a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-344-01	Extra Strength TYLENOL Cold Plus Flu Multi-ActionDay	12 in 1 BLISTER PACK	TABLET, FILM COATED	12		8
50580-344-01	Extra Strength TYLENOL Cold Plus Flu Multi-ActionDay	2 in 1 CARTON	TABLET, FILM COATED	2		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-344-01	EA - Each	50580-344	bb42db4e-7a0c-40fb-ac80-ce52e5c2bac1	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-344	EXTRA STRENGTH TYLENOL COLD PLUS FLU MULTI-ACTION DAY (ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]	8	Current NDC, Legacy NDC, 2 package rows	20241109_7d3266dc-879a-4d28-b8ea-74d238c3020a.zip

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 92 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Care Saline	SODIUM CHLORIDE	United Exchange Corp.	06737393-d4ae-3e7b-e063-6394a90ac19f	2025-10-31	Warnings	Exact identifier application number: M012
QUALITY CHOICE Maximum Strength Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	40416ff5-06e1-97dd-e063-6394a90a2046	2025-10-30	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Nighttime Cough DM	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	44feee2f-25bc-48d4-8e13-db1d9daaaa90	2025-10-30	Warnings	Exact identifier application number: M012
Robitussin Day and Night Cough Relief DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	b3d02c91-8f79-4eb4-a378-1072474c572c	2025-10-30	Warnings	Exact identifier application number: M012
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7	2025-10-30	Warnings	Exact identifier application number: M012
Endal	TRIPROLIDINE HCL, DEXTROMETHORPHAN HBR	Poly Pharmaceuticals, Inc.	fc5401e2-ed65-72e7-e053-6294a90a81f3	2025-10-30	Warnings	Exact identifier application number: M012
daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Publix Super Markets Inc	c7cef266-46fc-49ab-a2e7-54fc56298659	2025-10-30	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	SAM'S WEST INC	16592ad7-b7cb-0837-e063-6394a90ae059	2025-10-29	Warnings	Exact identifier application number: M012
Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL	SAFEWAY	013b94a1-26c7-4371-981a-d1b9d7fd1c98	2025-10-29	Warnings	Exact identifier application number: M012
Better Living	PHENYLEPHRINE HYDROCHLORIDE	BETTER LIVING BRANDS LLC	aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1	2025-10-29	Warnings	Exact identifier application number: M012
AXIM DayTime - Night Time 72 Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	VIVUNT PHARMA LLC	de9eb2d5-ba51-4637-e053-2995a90a0451	2025-10-29	Warnings	Exact identifier application number: M012
Dollar General Vapor Steam	CAMPHOR (SYNTHETIC)	DOLGENCORP, LLC	86d0f3ac-1359-c2f9-e053-2a91aa0a35d0	2025-10-29	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Wal-Mart Stores,Inc.,	a748d5ab-901c-47bb-8437-997542ecebfe	2025-10-28	Warnings	Exact identifier application number: M012
Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom Relief	CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	WAL-MART STORES,INC.	68a68574-0fcb-4569-be57-d9aee5f62bea	2025-10-28	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	635009a1-6154-4c62-a4be-d4f32c2cef8d	2025-10-28	Warnings	Exact identifier application number: M012
Family Care Nasal Relief	OXYMETAZOLINE HYDROCHLORIDE	United Exchange Corp	6d0f8e9e-0503-522b-e053-2a91aa0aca35	2025-10-28	Warnings	Exact identifier application number: M012
Family Care Nasal Relief	OXYMETAZOLINE HYDROCHLORIDE	United Exchange Corp	6d0eef2f-f546-d769-e053-2991aa0a8fe4	2025-10-28	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest Congestion Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	P & L Development, LLC	4af67ba7-8892-442c-b9fb-80aba9140e05	2025-10-28	Warnings	Exact identifier application number: M012
No Drip Nasal Mist Nasal Decongestant Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	994fa270-65bb-4097-b88a-d5ce3c0e1c79	2025-10-27	Warnings	Exact identifier application number: M012
Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	WAL-MART STORES INC.	3652ee94-b762-4100-a305-5acbec5f795a	2025-10-27	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1250743	acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet	PSN	7d3266dc-879a-4d28-b8ea-74d238c3020a	8
1250743	acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	7d3266dc-879a-4d28-b8ea-74d238c3020a	8
1250743	APAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet	SY	7d3266dc-879a-4d28-b8ea-74d238c3020a	8
2558505	{1 (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) / 1 (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) } Pack	GPCK	712ba011-79aa-469b-9f0f-04a0b4b705bd	6
2558505	1 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet) Pack	PSN	712ba011-79aa-469b-9f0f-04a0b4b705bd	6
1089968	acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet	PSN	712ba011-79aa-469b-9f0f-04a0b4b705bd	6
1250743	acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet	PSN	712ba011-79aa-469b-9f0f-04a0b4b705bd	6
1089968	acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	712ba011-79aa-469b-9f0f-04a0b4b705bd	6
1250743	acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	712ba011-79aa-469b-9f0f-04a0b4b705bd	6
2558505	1 daytime (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) Pack	SY	712ba011-79aa-469b-9f0f-04a0b4b705bd	6
1089968	APAP 500 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet	SY	712ba011-79aa-469b-9f0f-04a0b4b705bd	6
1250743	APAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet	SY	712ba011-79aa-469b-9f0f-04a0b4b705bd	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-344-01	50580034401	2 BLISTER PACK in 1 CARTON (50580-344-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2021-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Extra Strength TYLENOL Cold + Flu Multi-Action Day/Night	Kenvue Brands LLC	2024-11-08	HUMAN OTC DRUG LABEL	6
Extra Strength TYLENOL Cold + Flu Multi-Action Day	Kenvue Brands LLC	2024-11-07	HUMAN OTC DRUG LABEL	8