NDC 50580-362

Sudafed PE Pressure Plus Pain Plus Cough Day

Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

Sudafed PE Pressure Plus Pain Plus Cough Day 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; Phenylephrine Hydrochloride.

• Product ID: 50580-362_001d5c8b-9296-432b-94bf-cb4425e7a0d9
• NDC: 50580-362
• Product Type: Human Otc Drug
• Proprietary Name: Sudafed PE Pressure Plus Pain Plus Cough Day
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-06-25
• 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; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/15mL; mg/15mL; mg/15mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50580-362-01

240 mL in 1 BOTTLE (50580-362-01)

• Marketing Start Date: 2018-06-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-362-01 [50580036201]

Sudafed PE Pressure Plus Pain Plus Cough Day SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-06-25

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/15mL

OpenFDA Data

• SPL SET ID: b70e4fd1-be16-4258-8ce2-9d1e814b64d8
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1113705

NDC Crossover Matching brand name "Sudafed PE Pressure Plus Pain Plus Cough Day" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
50580-362	Sudafed PE Pressure Plus Pain Plus Cough Day	Sudafed PE Pressure Plus Pain Plus Cough Day
36800-521	Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
36800-921	Cold Max Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
36800-514	Cold plus Head Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
36800-924	Cold Plus Head Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
41250-138	COLD RELIEF MULTI-SYMPTOM DAYTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
33992-0611	Daytime	Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
0363-8998	Daytime Non-Drowsy Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
37808-539	HEB DayTime Flu And Severe Cold And Cough	Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
30142-112	Kroger DayTime Flu plus Severe Cold and Cough	Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
0363-5556	Maximum Strength Congestion and Headache	Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
0363-9019	Maximum Strength Congestion and Headache	Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
33992-6110	Multi Symptom Daytime	Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
30142-768	Non Drowsy Daytime Cold and Flu Softgel	acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride
41163-172	Pressure and Pain PE plus Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
36800-772	Pressure Plus Pain PE Plus Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
11822-2112	Rite Aid Daytime Severe Cold and Cough Relief	Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
0031-8721	ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
41190-112	ShopRite DayTime Flu Plus Severe Cold And Cough	Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
29485-2827	Vicks DayQuil	Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
37000-555	Vicks DayQuil	Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
37000-558	Vicks DayQuil	Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
37000-539	VIcks Flu Therapy	acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride
0363-1166	Walgreens Daytime Non-Drowsy Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
0363-1167	Walgreens Daytime Non-Drowsy Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE