NDC 0536-1291

Phenylephrine HCl Maximum Strength

Phenylephrine Hcl

Phenylephrine HCl Maximum Strength is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories. The primary component is Phenylephrine Hydrochloride.

Product ID0536-1291_0af50e55-4ba6-441f-96a9-0e885c45d0ae
NDC0536-1291
Product TypeHuman Otc Drug
Proprietary NamePhenylephrine HCl Maximum Strength
Generic NamePhenylephrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-04-09
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRugby Laboratories
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0536-1291-36

2 BLISTER PACK in 1 CARTON (0536-1291-36) > 18 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2020-04-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-1291-36 [00536129136]

Phenylephrine HCl Maximum Strength TABLET, FILM COATED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-04-09

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:953cad64-d587-4f25-a04f-fee2edf9ebb2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049182
  • UPC Code
  • 0305361291365
  • NDC Crossover Matching brand name "Phenylephrine HCl Maximum Strength" 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

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