Tylenol Cold plus Flu plus Cough

Product NDC
50580-369
11-digit product format
505800369
Labeler code
50580
Product ID
50580-369_21e8a73b-cb4a-6770-e063-6294a90a4a53
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-17
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tylenol Cold plus Flu plus Cough
Brand name suffix
Night
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
DOXYLAMINE SUCCINATE6.25 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ
Rxcui1431245

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-369-01Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack240 mL in 1 BOTTLESOLUTION240 mL6.25 mg in 15mL9
50580-369-01Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack240 mL in 1 BOTTLESOLUTION240 mL6.25 mg in 15mL8
50580-369-01Tylenol Cold plus Flu plus CoughNight240 mL in 1 BOTTLESOLUTION2404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-369-01ML - Milliliter50580-3699233e435-d62d-4e55-a8e2-29d6da3d872512020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-369TYLENOL COLD PLUS FLU SEVERE DAY AND TYLENOL COLD PLUS FLU PLUS COUGH NIGHT 2-PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]9Current NDC, Legacy NDC20250223_77a2dc96-73ee-4ca2-b1fe-406995802606.zip
50580-369TYLENOL COLD PLUS FLU SEVERE DAY AND TYLENOL COLD PLUS FLU PLUS COUGH NIGHT 3-PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]8Current NDC, Legacy NDC20241109_464de5de-0e7a-41d6-875f-dd0e5fe7893c.zip
50580-369TYLENOL COLD PLUS FLU PLUS COUGH NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 1 package rows20241109_e85e5eb9-3ecf-4784-999e-111e38e306f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637731{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } PackGPCK77a2dc96-73ee-4ca2-b1fe-4069958026069
26377311 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) PackPSN77a2dc96-73ee-4ca2-b1fe-4069958026069
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN77a2dc96-73ee-4ca2-b1fe-4069958026069
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral SolutionPSN77a2dc96-73ee-4ca2-b1fe-4069958026069
1431245acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD77a2dc96-73ee-4ca2-b1fe-4069958026069
1369842acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD77a2dc96-73ee-4ca2-b1fe-4069958026069
26377311 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) PackSY77a2dc96-73ee-4ca2-b1fe-4069958026069
1431245acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY77a2dc96-73ee-4ca2-b1fe-4069958026069
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY77a2dc96-73ee-4ca2-b1fe-4069958026069
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY77a2dc96-73ee-4ca2-b1fe-4069958026069
1369842acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY77a2dc96-73ee-4ca2-b1fe-4069958026069
1431245APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSY77a2dc96-73ee-4ca2-b1fe-4069958026069
1369842APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSY77a2dc96-73ee-4ca2-b1fe-4069958026069
2637731{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } PackGPCK464de5de-0e7a-41d6-875f-dd0e5fe7893c8
26377311 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) PackPSN464de5de-0e7a-41d6-875f-dd0e5fe7893c8
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN464de5de-0e7a-41d6-875f-dd0e5fe7893c8
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral SolutionPSN464de5de-0e7a-41d6-875f-dd0e5fe7893c8
1431245acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD464de5de-0e7a-41d6-875f-dd0e5fe7893c8
1369842acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD464de5de-0e7a-41d6-875f-dd0e5fe7893c8
26377311 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) PackSY464de5de-0e7a-41d6-875f-dd0e5fe7893c8
1431245acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY464de5de-0e7a-41d6-875f-dd0e5fe7893c8
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY464de5de-0e7a-41d6-875f-dd0e5fe7893c8
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY464de5de-0e7a-41d6-875f-dd0e5fe7893c8
1369842acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY464de5de-0e7a-41d6-875f-dd0e5fe7893c8
1431245APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSY464de5de-0e7a-41d6-875f-dd0e5fe7893c8
1369842APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSY464de5de-0e7a-41d6-875f-dd0e5fe7893c8
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral SolutionPSNe85e5eb9-3ecf-4784-999e-111e38e306f54
1431245acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDe85e5eb9-3ecf-4784-999e-111e38e306f54
1431245acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYe85e5eb9-3ecf-4784-999e-111e38e306f54
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYe85e5eb9-3ecf-4784-999e-111e38e306f54
1431245APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSYe85e5eb9-3ecf-4784-999e-111e38e306f54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-369-0150580036901240 mL in 1 BOTTLE (50580-369-01) 240 ml2019-06-170000-00-00NoNoCurrent