NDC 50580-550

Sudafed PE Pressure plus Pain plus Cough

Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

Sudafed PE Pressure plus Pain plus Cough 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; Phenylephrine Hydrochloride.

• Product ID: 50580-550_f0f27e98-4a14-42ae-ab2d-cad2fb1f3370
• NDC: 50580-550
• Product Type: Human Otc Drug
• Proprietary Name: Sudafed PE Pressure plus Pain plus Cough
• Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-02-25
• 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/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50580-550-24

2 BLISTER PACK in 1 CARTON (50580-550-24) > 12 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2013-02-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-550-24 [50580055024]

Sudafed PE Pressure plus Pain plus Cough TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-02-25

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: dc3a3b2e-566a-421c-b09b-cf40329724a4
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1094538

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

NDC	Brand Name	Generic Name
50580-550	Sudafed PE Pressure plus Pain plus Cough	Sudafed PE Pressure plus Pain plus Cough
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