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 59 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinu-Phen Plus Sinus Pain and Pressure	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Wildman Business Group	c66e0b52-5531-4a84-ae90-8a26d27df1ec	2026-01-12	Warnings	Exact identifier application number: M012
SU PHEDRINE PE SINUS CONGESTION	PHENYLEPHRINE HCL	Salado Sales, Inc.	ba075ff7-4e26-4856-8335-0c7dd4e198ea	2026-01-12	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	bab078bb-f6b0-4394-84de-92b2c582b5da	2026-01-12	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Non-Drowsy Maximum Strength	PHENYLEPHRINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d	2026-01-12	Warnings	Exact identifier application number: M012
CVS Health Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	CVS Pharmacy	022c3083-c611-47d0-aa93-d6c7612e7a47	2026-01-11	Warnings	Exact identifier application number: M012
CVS Health Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	CVS Pharmacy	bf73d15a-9d68-42fa-bfee-d25748215f97	2026-01-11	Warnings	Exact identifier application number: M012
GUAIFENESIN 400MG CAPLETS	GUAIFENESIN	Gendose Pharmaceuticals, LLC	e7b82ec7-ef23-50c1-e053-2a95a90a662f	2026-01-10	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	DAYTIME COLD AND FLU	Allegiant Health	69ed2da0-16b2-49eb-91b4-cc5cf328c817	2026-01-09	Warnings	Exact identifier application number: M012
HyVee Cough Drops Original Herb	MENTHOL	HY-VEE, INC	47f81e54-0ce4-439d-e063-6294a90a2abe	2026-01-09	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	A-S Medication Solutions	a5809774-ed52-4f54-b48e-888631e0223d	2026-01-09	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	A-S Medication Solutions	5767f546-a751-4583-a8b7-971175c27ef0	2026-01-09	Warnings	Exact identifier application number: M012
Thompson Cough and Cold Multi-Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE, GUAIFENESIN, ,	Thompson	e77725b1-15da-35bd-e053-2a95a90ad6ba	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Childrens Multi-Symptom Grape	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Menper Distributors, Inc.	266c8cce-cdf9-557d-e063-6394a90a9bc3	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Multi-Symptom Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Menper Distributors, Inc.	2669c620-ab70-abaa-e063-6394a90a58e7	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Multi-Symptom Cherry	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Menper Distributors, Inc.	26b8c06d-4a72-3979-e063-6394a90a96d7	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Max with Acetaminophen	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE	Menper Distributors, Inc.	26a4861b-5d8e-9ec6-e063-6394a90af577	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Severe Multi-Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Menper Distributors, Inc.	26a69342-f65f-cb46-e063-6394a90ade10	2026-01-08	Warnings	Exact identifier application number: M012
HyVee Cough Drops Original Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	e4e15c13-f583-4484-a5f0-f04c39c7b7c9	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy	ASPRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	a355d987-77ce-9e32-e053-2995a90a6431	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	e07931fc-f753-1aeb-e053-2a95a90ada3f	2026-01-08	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