NDC 50580-547

SUDAFED PE Pressure Plus Pain

Acetaminophen And Phenylephrine Hydrochloride

SUDAFED PE Pressure Plus Pain 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; Phenylephrine Hydrochloride.

• Product ID: 50580-547_1b9e1435-55e8-4146-9ddf-23a5fc54d1b2
• NDC: 50580-547
• Product Type: Human Otc Drug
• Proprietary Name: SUDAFED PE Pressure Plus Pain
• Generic Name: Acetaminophen And Phenylephrine Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-07-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Substance Name: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50580-547-25

2 BLISTER PACK in 1 CARTON (50580-547-25) > 12 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2012-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-547-72 [50580054772]

SUDAFED PE Pressure Plus Pain TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-07-01
• Marketing End Date: 2015-12-02

NDC 50580-547-25 [50580054725]

SUDAFED PE Pressure Plus Pain TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-07-01

NDC 50580-547-73 [50580054773]

SUDAFED PE Pressure Plus Pain TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-12-21

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: 8538c291-9ce9-4866-b268-f4cbdb52f5bd
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1046378
  • 1101529

NDC Crossover Matching brand name "SUDAFED PE Pressure Plus Pain" or generic name "Acetaminophen And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
50580-547	SUDAFED PE Pressure Plus Pain	acetaminophen and phenylephrine hydrochloride
46017-024	Contac Cold and Flu	acetaminophen and phenylephrine hydrochloride
46017-021	Contac Cold and Flu Day	acetaminophen and phenylephrine hydrochloride
50804-100	Daytime sinus	Acetaminophen and Phenylephrine Hydrochloride
33992-1100	Daytime Sinus Relief	Acetaminophen and Phenylephrine Hydrochloride
36800-098	Daytime Sinus Relief	Acetaminophen and Phenylephrine Hydrochloride
36800-911	Pressure and Pain PE	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
41250-220	Pressure and Pain PE	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
50804-003	Pressure Plus Pain PE	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
50804-476	Pressure plus Pain PE	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
41250-623	sinus and headache	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
46122-658	Sinus and Headache	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
50804-123	Sinus and Headache	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
41520-099	Sinus Daytime	Acetaminophen and Phenylephrine Hydrochloride
46122-453	Sinus Headache	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
36800-322	Sinus plus Headache	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
41250-534	Sinus plus Headache	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
41250-207	sinus pressure and pain PE	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
50804-220	sinus pressure and pain pe	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
36800-320	Sinus Pressure plus Pain PE	ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
50580-435	Sudafed PE Sinus Pressure Plus Pain	Acetaminophen and Phenylephrine hydrochloride
50580-598	TYLENOL SINUS PLUS HEADACHE	Acetaminophen and Phenylephrine hydrochloride
37000-507	Vicks Sinex	Acetaminophen and Phenylephrine Hydrochloride