FDA.reportPublic FDA data

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
IngredientStrength
ACETAMINOPHEN325 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1243679Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ce43e5c2-fe96-4462-882c-d7479318b33dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-566-25TylenolCold Plus Head Congestion Severe2 in 1 CARTONTABLET, FILM COATED216
50580-566-25TylenolCold Plus Head Congestion Severe12 in 1 BLISTER PACKTABLET, FILM COATED1216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DTYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
GuaifenesinACTIVE INGREDIENT495W7451VQTYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJTYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
AcetaminophenACTIVE MOIETY362O9ITL9DTYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
GuaifenesinACTIVE MOIETY495W7451VQTYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
PhenylephrineACTIVE MOIETY1WS297W6MVTYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48TYLENOL 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 INGREDIENT66O7AQV0RTTYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4TYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTYLENOL COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
triacetinINACTIVE INGREDIENTXHX3C3X673TYLENOL 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
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-566TYLENOL COLD PLUS HEAD CONGESTION SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]16Current NDC, Legacy NDC, 2 package rows20241109_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 58 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pocket FarmacyMENTHOLSaje Natural Business Inc.bdc15c6f-73b4-488e-9134-e70565df71bb2026-01-14WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HCL 50 MGDIPHENHYDRAMINE HCLYYBA Corporation4b012549-3958-43c1-9de7-897c5d8b20d32026-01-14WarningsExact identifier
application number: M012
Rite Aid Pharmacy congestion relief vaporizing steamVAPORIZING STEAMRite Aid Pharmacy0fb86b23-0313-8fd8-e063-6394a90a0f5f2026-01-14WarningsExact identifier
application number: M012
Vapo SteamVAPO STEAMTOPCO ASSOCIATES, LLCf216f69f-9580-25ac-e053-2995a90a5ac62026-01-14WarningsExact identifier
application number: M012
Leader Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leaderf27bf0b2-25cc-474c-ab6b-f227ed3525fa2026-01-14WarningsExact identifier
application number: M012
Sinus PE plus AllergyCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLWalgreen Companya15979d4-87bf-42e7-b1f2-7834960721412026-01-13WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.41f4bf6d-f83c-92e4-e063-6394a90aebab2026-01-13WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e608643-1a74-b474-e063-6294a90ad2e02026-01-13WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC462cbf3d-51b1-dab9-e063-6394a90a70ba2026-01-13WarningsExact identifier
application number: M012
Pocket FarmacyMENTHOLSaje Natural Business Inc.4260542e-0980-4b0b-8177-1c9f2c53b5a62026-01-13WarningsExact identifier
application number: M012
Sweet ComfortMENTHOLSaje Natural Business Inc.cf13cccd-723d-4d61-8a5e-b36281605cc72026-01-13WarningsExact identifier
application number: M012
FortifyMENTHOLSaje Natural Business Inc.0320a305-99d1-4909-94cc-cd6509ecb9482026-01-13WarningsExact identifier
application number: M012
Rolling FarmacyMENTHOLSaje Natural Business Inc.a38765a9-22cd-4fc5-b5ab-c3cacbd52c742026-01-13WarningsExact identifier
application number: M012
Home FarmacyMENTHOLSaje Natural Business Inc.add35d10-b27a-4ae8-b2de-8a285aaef1552026-01-13WarningsExact identifier
application number: M012
Traveling FarmacyMENTHOLSaje Natural Business Inc.5b70f5aa-ed36-65ab-e053-2a91aa0a67772026-01-13WarningsExact identifier
application number: M012
sinus plus allergy PE maximum strengthCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI660d3c80-f249-41dd-aa93-a0b1e635ead02026-01-13WarningsExact identifier
application number: M012
Chest ComfortMENTHOLSaje Natural Business Inc.8a3db169-6dd7-4dfd-8360-90315288f21b2026-01-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLH E Bc9e977b6-fba6-49ea-9d80-b43b0842bbe12026-01-12WarningsExact identifier
application number: M012
PE Sinus CongestionPHENYLEPHRINE HCLTopco Associates, LLC3264e291-7a0f-4e25-8390-ba441f22f6502026-01-12WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACY3f44cff6-240a-4a8d-aaa1-0da75a31a47b2026-01-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNce43e5c2-fe96-4462-882c-d7479318b33d16
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDce43e5c2-fe96-4462-882c-d7479318b33d16
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYce43e5c2-fe96-4462-882c-d7479318b33d16
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYce43e5c2-fe96-4462-882c-d7479318b33d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-566-25505800566252 BLISTER PACK in 1 CARTON (50580-566-25) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2013-07-150000-00-00NoNoCurrent