FDA.reportPublic FDA data

Childrens TYLENOL

Product NDC
50580-194
11-digit product format
505800194
Labeler code
50580
Product ID
50580-194_21d4a287-1f3b-ce36-e063-6294a90a1ef3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Dextromethorphan Hydrobromide
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-06-26
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
160; 5 mg/5mL; mg/5mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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
Childrens TYLENOL
Brand name suffix
COLD PLUS COUGH PLUS SORE THROAT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1370113Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e83f7911-22b4-4ffc-8f49-68f6acd2ebf5Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-194-012024-02-01C16284748780-11030e365-51bf-111a-e063-dadaa90a10e2Children's TYLENOL ® COLD + COUGH + SORE THROAT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-194-01Childrens TYLENOLCOLD PLUS COUGH PLUS SORE THROAT120 mL in 1 BOTTLESUSPENSION1206
50580-194-01Childrens TYLENOLCOLD PLUS COUGH PLUS SORE THROAT1 in 1 CARTONSUSPENSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-194-01ML - Milliliter50580-19466058b11-241c-4617-9589-0b6d20b852fb12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-194CHILDRENS TYLENOL COLD PLUS COUGH PLUS SORE THROAT (ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 2 package rows20241109_e83f7911-22b4-4ffc-8f49-68f6acd2ebf5.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 77 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf6401b58-8cf8-4067-e053-2995a90a68fc2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1ba37b8-4558-0808-e053-2995a90a9f5e2025-12-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb84f37bc-be37-4f2b-83ee-d7d1341844902025-12-11WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1b7c7fc-1068-f486-e053-2a95a90a8e8c2025-12-11WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1b9e0da-2c54-8b31-e053-2995a90a690b2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf6b3ca40-7638-477f-b800-4c28c40ff0a82025-12-11WarningsExact identifier
application number: M012
Allergy ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company0a6e3251-02e0-42c1-bdf3-51c77f88c17f2025-12-11WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLC516ab016-31f9-4829-8b94-2f968933093c2025-12-11WarningsExact identifier
application number: M012
Sinus PE CongestionDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company5b9151b7-3e40-4f37-b3e0-4c0fa0115b712025-12-10WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDiscount Drug Mart2344c048-0550-4c31-b54e-a198910c490e2025-12-10WarningsExact identifier
application number: M012
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACY, INCcf4eb4c4-68e0-4478-a81c-d3d1e66f5cc52025-12-10WarningsExact identifier
application number: M012
Tylenol Cold plus Flu Severe, Lil Drug StoreACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil Drug Store Products, Incf395c196-62d7-47ff-b38d-af37adf5980b2025-12-10WarningsExact identifier
application number: M012
Tylenol Sinus Severe, Lil Drug StoreACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil Drug Store Products, Inc88b68447-b016-4d5b-a5e3-c4ebccb14f8c2025-12-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamily Dollar Services Incd956f1b8-91f8-424b-bb6c-704c445b6f4c2025-12-10WarningsExact identifier
application number: M012
good neighbor pharmacy day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergene5c1bd96-d27d-49c1-b3b8-eee53a145ef52025-12-10WarningsExact identifier
application number: M012
NiteTime SEVERE Cold and Flu Relief SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC3ffe67bf-2c66-61e6-e063-6394a90a7f8f2025-12-10WarningsExact identifier
application number: M012
DayTime SEVERE Cold and Flu Relief SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC3ffe0f43-b92a-f947-e063-6394a90ab72c2025-12-10WarningsExact identifier
application number: M012
MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCa7285fe0-5a5b-42c4-be47-9a07a2ba75e82025-12-10WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporationf9b8dbe1-7ff9-4320-850c-6e86e98d43932025-12-09WarningsExact identifier
application number: M012
Severe NasalOXYMETAZOLINE HYDROCHLORIDE 0.05%ALAINA HEALTHCARE PRIVATE LIMITED27747a10-8d1d-41c2-80b9-45452f3b9abc2025-12-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370113acetaminophen 160 MG / dextromethorphan HBr 5 MG in 5 mL Oral SuspensionPSNe83f7911-22b4-4ffc-8f49-68f6acd2ebf56
1370113acetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SuspensionSCDe83f7911-22b4-4ffc-8f49-68f6acd2ebf56
1370113acetaminophen 160 MG / dextromethorphan HBr 5 MG per 5 ML Oral SuspensionSYe83f7911-22b4-4ffc-8f49-68f6acd2ebf56
1370113APAP 160 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral SuspensionSYe83f7911-22b4-4ffc-8f49-68f6acd2ebf56
1370113APAP 32 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SuspensionSYe83f7911-22b4-4ffc-8f49-68f6acd2ebf56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-194-01505800194011 BOTTLE in 1 CARTON (50580-194-01) / 120 mL in 1 BOTTLE1 bottle2017-06-260000-00-00NoNoCurrent