NDC 37000-528

Sinex Severe plus Vicks VapoCool

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride

Sinex Severe plus Vicks VapoCool 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: 37000-528_6f40ca67-8423-e6ad-e053-2991aa0adf8e
• NDC: 37000-528
• Product Type: Human Otc Drug
• Proprietary Name: Sinex Severe plus Vicks VapoCool
• 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 37000-528-08

236 mL in 1 BOTTLE, PLASTIC (37000-528-08)

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

NDC SPL Data Element Entries

NDC 37000-528-08 [37000052808]

Sinex Severe plus Vicks VapoCool 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: 6f40021d-1dec-5745-e053-2a91aa0a792c
• Manufacturer:
  • The Procter & Gamble Manufacturing Company
• UNII:
  • V9BI9B5YI2
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1431245

NDC Crossover Matching brand name "Sinex Severe plus Vicks VapoCool" 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