NDC 50580-369

Tylenol Cold plus Flu plus Cough Night

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride

Tylenol Cold plus Flu plus Cough Night is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride.

• Product ID: 50580-369_ec2b0f73-44d3-4cfe-b9fb-39adac987116
• NDC: 50580-369
• Product Type: Human Otc Drug
• Proprietary Name: Tylenol Cold plus Flu plus Cough Night
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2019-06-17
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50580-369-01

240 mL in 1 BOTTLE (50580-369-01)

• Marketing Start Date: 2019-06-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-369-01 [50580036901]

Tylenol Cold plus Flu plus Cough Night SOLUTION

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-06-17

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/15mL

OpenFDA Data

• SPL SET ID: e85e5eb9-3ecf-4784-999e-111e38e306f5
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1431245
• UPC Code:
  • 0300450562081

NDC Crossover Matching brand name "Tylenol Cold plus Flu plus Cough Night" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
0280-0922	Alka-Seltzer Plus Night Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
36800-848	Cold and Flu Severe Nighttime	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
63824-593	Mucinex Fast-Max	Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, and Phenylephrine Hydrochloride
0363-6140	NightTime Cold	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
37000-530	NyQuil Severe plus	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
69423-989	NyQuil VapoCOOL SEVERE	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
0363-0114	SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
0363-8997	SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
36800-659	SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
49035-624	SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
49035-669	SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
68210-4087	SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
37000-528	Sinex Severe plus	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
64336-175	Sinex Severe plus	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
50580-571	TYLENOL COLD MAX	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
50580-369	Tylenol Cold plus Flu plus Cough	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
37000-531	Vicks Formula 44 VapoCool	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
37000-812	Vicks NyQuil	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride
37000-815	Vicks NyQuil	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
0363-6111	Walgreen Nighttime Cold and Flu	acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride