NDC 15127-081

PSEUDO-FREE PE Maximum Strength, Non-Drowsy

Phenylephrine Hcl

PSEUDO-FREE PE Maximum Strength, Non-Drowsy is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by L&r Distributors, Inc.. The primary component is Phenylephrine H.

Product ID15127-081_4014d047-ff43-4537-87b0-315cc28c408b
NDC15127-081
Product TypeHuman Otc Drug
Proprietary NamePSEUDO-FREE PE Maximum Strength, Non-Drowsy
Generic NamePhenylephrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-01-14
Marketing CategoryOTC MONOGRAPH F / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameL&R Distributors, Inc.
Substance NamePHENYLEPHRINE H
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 15127-081-03

1 BOTTLE in 1 PACKAGE (15127-081-03) > 10 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2005-01-14
Marketing End Date2021-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 15127-081-18 [15127008118]

PSEUDO-FREE PE Maximum Strength, Non-Drowsy TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-01-14
Marketing End Date2021-09-10

NDC 15127-081-03 [15127008103]

PSEUDO-FREE PE Maximum Strength, Non-Drowsy TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-01-14
Marketing End Date2021-09-10

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

NDC Crossover Matching brand name "PSEUDO-FREE PE Maximum Strength, Non-Drowsy" or generic name "Phenylephrine Hcl"

NDCBrand NameGeneric Name
0363-4531Nasal DecongestantPhenylephrine HCl
30142-953Nasal DecongestantPhenylephrine HCl
33992-0453Nasal DecongestantPhenylephrine HCl
21130-453Nasal Decongestant PEPhenylephrine HCl
37808-453Nasal Decongestant PEPhenylephrine HCl
36800-704PE Sinus CongestionPhenylephrine HCl
0536-1291Phenylephrine HClPhenylephrine HCl
0924-0133PhysiciansCare SinusPhenylephrine HCL
15127-081PSEUDO-FREE PEPhenylephrine HCl
0031-9305Robitussin Direct Stuffy NosePhenylephrine hcl
30142-853Sinus CongestionPhenylephrine HCl
11673-453sinus PEPhenylephrine HCl
11822-4530Sinus Pressure and Congestion Relief PEPhenylephrine HCl
0904-5733Sudogest PEPhenylephrine HCl
0363-0453Wal-Phed PEPhenylephrine HCl

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.