NDC 50580-679

Sudafed PE Pressure Plus Pain Plus Cold

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Sudafed PE Pressure Plus Pain Plus Cold is a Oral Tablet, Film Coated 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; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 50580-679_43a5adb0-2f64-40ee-9149-f2adfd00e8c9
• NDC: 50580-679
• Product Type: Human Otc Drug
• Proprietary Name: Sudafed PE Pressure Plus Pain Plus Cold
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-08-01
• 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; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50580-679-25

2 BLISTER PACK in 1 CARTON (50580-679-25) > 12 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2013-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-679-25 [50580067925]

Sudafed PE Pressure Plus Pain Plus Cold TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-08-01

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: cad07288-08bc-4d51-96b2-bbefdcdee18a
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1098435

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

NDC	Brand Name	Generic Name
50580-679	Sudafed PE Pressure Plus Pain Plus Cold	Sudafed PE Pressure Plus Pain Plus Cold
0280-0921	Alka-Seltzer Plus Day Severe Cold Plus Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-502	COLD AND FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-986	Cold and Flu Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37000-524	DayQuil Severe plus Vicks VapoCool	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
37808-178	DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-474	Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-298	Mucus Relief Cold and Flu All In One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-697	Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-764	Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-164	Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-497	Mucus Relief Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37808-079	Mucus Relief Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
36800-775	Pressure Plus Pain PE Plus Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
15127-184	Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
37000-810	Vicks DayQuil	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
37000-811	Vicks DayQuil	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
0363-8591	Walgreens Severe Cold Multi-Symptom For Adults	acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride