NDC 50580-299

Childrens TYLENOL COLD Plus FLU

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

Childrens TYLENOL COLD Plus FLU is a Oral Suspension 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; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 50580-299_a358bcd5-c4f6-40fa-b552-49bd4a2fd7e7
• NDC: 50580-299
• Product Type: Human Otc Drug
• Proprietary Name: Childrens TYLENOL COLD Plus FLU
• Generic Name: Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2017-06-26
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Substance Name: ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 160 mg/5mL; mg/5mL; mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50580-299-01

1 BOTTLE in 1 CARTON (50580-299-01) > 120 mL in 1 BOTTLE

• Marketing Start Date: 2017-06-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-299-01 [50580029901]

Childrens TYLENOL COLD Plus FLU SUSPENSION

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-06-26

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

OpenFDA Data

• SPL SET ID: 8b516736-86ac-47cb-a0ec-038d4c3a0020
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • V1Q0O9OJ9Z
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1113397
• UPC Code:
  • 0300450391056

NDC Crossover Matching brand name "Childrens TYLENOL COLD Plus FLU" or generic name "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
57344-139	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
57344-161	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0280-1121	Alka-Seltzer Plus	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
50580-299	Childrens TYLENOL	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
50580-456	Childrens TYLENOL	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
46122-409	Cold Head Congestion	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
57344-162	Cold Head Congestion Daytime / Nighttime	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
41520-598	Cold Head Congestion Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
63868-074	Cold Head Congestion Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
46122-411	Cold Max Day and Night	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
53943-139	COLD MAX MULTI SYMPTOM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
68016-510	Cold Max Multi Symptom Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
36800-914	Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
53943-239	Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
63868-015	Cold Multi Symptom Daytime Nighttime	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
63868-072	Cold Multi Symptom Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
50804-551	Cold Multi-Symptom Daytime and Nighttime	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
57344-150	Cold Multi-Symptom Daytime Nighttime	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
41520-599	Cold Multi-Symptom Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
68998-139	Cold Multi-Symptom Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
36800-927	Cold Plus Head Congestion Day and Night	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
36800-925	Cold Plus Head Congestion Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
36800-250	Cold Relief Multi-Symptom	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
41250-150	COLD RELIEF MULTI-SYMPTOM	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride