NDC 37000-531

Vicks Formula 44 VapoCool Severe Nighttime Cough and Cold

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride

Vicks Formula 44 VapoCool Severe Nighttime Cough and Cold is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by The Procter & Gamble Manufacturing Company. The primary component is Phenylephrine Hydrochloride; Doxylamine Succinate; Dextromethorphan Hydrobromide; Acetaminophen.

• Product ID: 37000-531_6f7cef16-c2ef-80ac-e053-2991aa0a72de
• NDC: 37000-531
• Product Type: Human Otc Drug
• Proprietary Name: Vicks Formula 44 VapoCool Severe Nighttime Cough and Cold
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-10
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: The Procter & Gamble Manufacturing Company
• Substance Name: PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
• Active Ingredient Strength: 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 37000-531-08

236 mL in 1 BOTTLE, PLASTIC (37000-531-08)

• Marketing Start Date: 2018-07-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 37000-531-08 [37000053108]

Vicks Formula 44 VapoCool Severe Nighttime Cough and Cold SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-07-10

Drug Details

Active Ingredients

Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	10 mg/30mL

OpenFDA Data

• SPL SET ID: 6f7cef16-c2ee-80ac-e053-2991aa0a72de
• Manufacturer:
  • The Procter & Gamble Manufacturing Company
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1431245

NDC Crossover Matching brand name "Vicks Formula 44 VapoCool Severe Nighttime Cough and Cold" 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