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 34 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thieves Chest Rub	CHEST RUB	Young Living Essential Oils, LC.	9b7f125e-6caa-c53e-e053-2a95a90a737e	2026-05-06	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief Plus Pain and Headache	ACETAMINOPHEN, GUAIFENESIN	Shield Pharmaceuticals Corp	f20c0db1-dcf3-4bfc-b3e4-930398f82dc9	2026-05-06	Warnings	Exact identifier application number: M012
Nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Publix Super Markets Inc	8aa6492b-1723-4c6b-82ee-4f800301c6ad	2026-05-06	Warnings	Exact identifier application number: M012
Allergy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	047102c4-3d03-4b2d-961d-0ac75980147b	2026-05-06	Warnings	Exact identifier application number: M012
GOOD SENSE COMBO PACK DAYTIME AND NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	d25f2649-4f8a-4339-8443-faa0b98bdd70	2026-05-06	Warnings	Exact identifier application number: M012
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	WinCo Foods, LLC	27e911e1-6d22-4a50-8413-1809c8973cbd	2026-05-06	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Cough Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51173330-d537-fb9c-e063-6394a90ae342	2026-05-05	Warnings	Exact identifier application number: M012
Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	08e74a8d-8e8d-4cda-9adc-ea2ff4068353	2026-05-05	Warnings	Exact identifier application number: M012
GOODSENSE COMBO PACK DAYTIME AND NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	L. Perrigo Company	e42f9e0d-f990-4c33-af43-75acf5d77638	2026-05-05	Warnings	Exact identifier application number: M012
Rugby Mucus and Chest Congestion 541	GUAIFENESIN	Rugby Laboratories	76472912-b66f-4bb4-937a-4a589683a78c	2026-05-04	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Daytime Non-Drowsy	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	H E B	e9dd2d7b-0a19-4a42-b51e-b9914f02406e	2026-05-04	Warnings	Exact identifier application number: M012
Sanatos Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Pharmadel LLC	3dd3ed85-0c0a-8390-e063-6294a90a668e	2026-05-04	Warnings	Exact identifier application number: M012
Good Sense Daytime non drowsy cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L. Perrigo Company	0122cd34-5817-4af5-a51a-8d176dee0a30	2026-05-04	Warnings	Exact identifier application number: M012
COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Safeway	d810a6a9-6112-4e9d-a396-36084b7e110e	2026-05-04	Warnings	Exact identifier application number: M012
Benadryl Allergy Ultratab	DIPHENHYDRAMINE HYDROCHLORIDE	Savings Distributors LLC	8d59d121-62a8-c43b-e053-2a95a90a5847	2026-05-01	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Savings Distributors LLC	8e87f8de-f83e-0f8d-e053-2a95a90a8d6a	2026-05-01	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Savings Distributors LLC	8eecb3f0-eb5e-e847-e053-2995a90a86bd	2026-05-01	Warnings	Exact identifier application number: M012
Sinus Pressure and Congestion Relief PE Maximum Strength	PHENYLEPHRINE HCL	Rite Aid Corporation	fccea3c5-42af-4939-82bc-d9409b75f91f	2026-05-01	Warnings	Exact identifier application number: M012
Night Time Cold and Flu original	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Harris Teeter, LLC	cfaf4b3d-fab4-424d-adbe-aaedca58912d	2026-04-30	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Harris Teeter, LLC	21e7d323-5b78-43aa-b0fc-34c2a864ab9a	2026-04-30	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