Tylenol

Product NDC: 50580-566
11-digit product format: 505800566
Labeler code: 50580
Product ID: 50580-566_21aceda5-2c34-23df-e063-6394a90acb09
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-07-15
Substance: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 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: Tylenol
Brand name suffix: Cold Plus Head Congestion Severe
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
GUAIFENESIN	200 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
495W7451VQ	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1243679	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
ce43e5c2-fe96-4462-882c-d7479318b33d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-566-25	TylenolCold Plus Head Congestion Severe	2 in 1 CARTON	TABLET, FILM COATED	2		16
50580-566-25	TylenolCold Plus Head Congestion Severe	12 in 1 BLISTER PACK	TABLET, FILM COATED	12		16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
Guaifenesin	ACTIVE MOIETY	495W7451VQ	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
hydroxypropyl cellulose (type e)	INACTIVE INGREDIENT	66O7AQV0RT	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
triacetin	INACTIVE INGREDIENT	XHX3C3X673	TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-566	TYLENOL COLD PLUS HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]	16	Current NDC, Legacy NDC, 2 package rows	20241109_ce43e5c2-fe96-4462-882c-d7479318b33d.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 79 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cherry Sore Throat Lozenge	BENZOCAINE	American Sales	49248a40-1ca3-6dd1-e054-00144ff88e88	2025-12-07	Warnings	Exact identifier application number: M012
Sugar Free Honey Lemon Cough Drops	MENTHOL	American Sales	4896cbd1-57dd-1fc6-e054-00144ff8d46c	2025-12-07	Warnings	Exact identifier application number: M012
cherry throat relief lozenges	BENZOCAINE	Cintas Corporation	49b25e9e-1d47-4a10-e054-00144ff8d46c	2025-12-07	Warnings	Exact identifier application number: M012
cherry sore throat lozenge	BENZOCAINE	CVS Pharmacy	3c54974d-9d15-2fa1-e054-00144ff88e88	2025-12-07	Warnings	Exact identifier application number: M012
honey lemon sore throat lozenges	BENZOCAINE	CVS Pharmacy	3c55009c-4b3e-135e-e054-00144ff8d46c	2025-12-07	Warnings	Exact identifier application number: M012
sugar free menthol cough drops	MENTHOL	CVS Pharmacy	3bdd24a8-3b44-00cd-e054-00144ff8d46c	2025-12-07	Warnings	Exact identifier application number: M012
sugar free honey lemon cough drops	MENTHOL	CVS Pharmacy	3c125b3a-e58f-5c06-e054-00144ff88e88	2025-12-07	Warnings	Exact identifier application number: M012
CVS Menthol Cough Drops	MENTHOL	CVS Pharmacy	de97d13b-bb67-d0e6-e053-2995a90aeb2c	2025-12-07	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	American Sales	34dd34d1-1a08-3470-e054-00144ff8d46c	2025-12-06	Warnings	Exact identifier application number: M012
DOLOGEN	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Kramer Novis	656ea9ba-c9cf-44c6-af40-b8ba292ce38a	2025-12-05	Warnings	Exact identifier application number: M012
Afrin No Drip Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC	a79b5541-864b-412a-a085-96986ed6af59	2025-12-05	Warnings	Exact identifier application number: M012
Afrin No Drip Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	346f32cb-74cb-4896-b770-76d5f829a17d	2025-12-05	Warnings	Exact identifier application number: M012
Afrin No Drip Original Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	530b2d27-5883-489e-87fa-90b45eb93b3c	2025-12-05	Warnings	Exact identifier application number: M012
Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine	CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	ee666963-e686-4374-b52b-a677f1cd4114	2025-12-05	Warnings	Exact identifier application number: M012
Afrin No-Drip Allergy Sinus	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC	3beb5839-7422-449d-e054-00144ff88e88	2025-12-05	Warnings	Exact identifier application number: M012
Coricidin HBP Nighttime Multi-Symptom Cold	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	513ca24f-1262-4a2d-e054-00144ff8d46c	2025-12-05	Warnings	Exact identifier application number: M012
Afrin Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	a49a506e-aca2-4af0-a50b-dca2c031e61d	2025-12-05	Warnings	Exact identifier application number: M012
Throat Coat Sweet Orange Fennel	MENTHOL	Traditional Medicinals, Inc.	a746cef4-1fb4-45cf-e053-2995a90a02c8	2025-12-05	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Health Pharma USA LLC	31755594-3e1c-b290-e063-6394a90aba61	2025-12-05	Warnings	Exact identifier application number: M012
Tabcin Extra Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL,	Pharmadel LLC	0670c33e-8a3c-ae00-e063-6294a90a165b	2025-12-05	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1243679	acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	ce43e5c2-fe96-4462-882c-d7479318b33d	16
1243679	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	ce43e5c2-fe96-4462-882c-d7479318b33d	16
1243679	APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	ce43e5c2-fe96-4462-882c-d7479318b33d	16
1243679	APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	ce43e5c2-fe96-4462-882c-d7479318b33d	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-566-25	50580056625	2 BLISTER PACK in 1 CARTON (50580-566-25) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2013-07-15	0000-00-00	No	No	Current