NDC 55319-453

Suphedrine PE

Phenylephrine Hcl

Suphedrine PE is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Family Dollar Services Inc. The primary component is Phenylephrine Hydrochloride.

• Product ID: 55319-453_53d6ec52-a6ed-40f9-9e77-106796bbb574
• NDC: 55319-453
• Product Type: Human Otc Drug
• Proprietary Name: Suphedrine PE
• Generic Name: Phenylephrine Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2005-01-14
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Family Dollar Services Inc
• Substance Name: PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 55319-453-08

1 BLISTER PACK in 1 CARTON (55319-453-08) > 24 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2005-01-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55319-453-08 [55319045308]

Suphedrine PE TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2005-01-14

Drug Details

Active Ingredients

Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: c11c4469-8ac9-4615-a7b3-4f2c812c045c
• Manufacturer:
  • Family Dollar Services Inc
• UNII:
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1049182
• UPC Code:
  • 0032251005572

NDC Crossover Matching brand name "Suphedrine PE" or generic name "Phenylephrine Hcl"

NDC	Brand Name	Generic Name
49035-354	Suphedrine PE	Suphedrine PE
49035-462	Suphedrine PE	Suphedrine PE
49035-502	Suphedrine PE	Suphedrine PE
55319-453	Suphedrine PE	Suphedrine PE
63981-453	Suphedrine PE	Suphedrine PE
64092-802	Suphedrine PE	Suphedrine PE
0363-4531	Nasal Decongestant	Phenylephrine HCl
30142-953	Nasal Decongestant	Phenylephrine HCl
33992-0453	Nasal Decongestant	Phenylephrine HCl
21130-453	Nasal Decongestant PE	Phenylephrine HCl
37808-453	Nasal Decongestant PE	Phenylephrine HCl
36800-704	PE Sinus Congestion	Phenylephrine HCl
0536-1291	Phenylephrine HCl	Phenylephrine HCl
0924-0133	PhysiciansCare Sinus	Phenylephrine HCL
15127-081	PSEUDO-FREE PE	Phenylephrine HCl
0031-9305	Robitussin Direct Stuffy Nose	Phenylephrine hcl
30142-853	Sinus Congestion	Phenylephrine HCl
11673-453	sinus PE	Phenylephrine HCl
11822-4530	Sinus Pressure and Congestion Relief PE	Phenylephrine HCl
0904-5733	Sudogest PE	Phenylephrine HCl
0363-0453	Wal-Phed PE	Phenylephrine HCl