NDC 36800-331

Congestion PE

Phenylephrine Hydrochloride

Congestion PE is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Phenylephrine Hydrochloride.

Product ID36800-331_6b66cb96-ab71-24c1-e053-2a91aa0a73df
NDC36800-331
Product TypeHuman Otc Drug
Proprietary NameCongestion PE
Generic NamePhenylephrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2011-08-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTopCo Associates LLC
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 36800-331-05

1 BOTTLE, PLASTIC in 1 CARTON (36800-331-05) > 150 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Start Date2011-08-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-331-05 [36800033105]

Congestion PE TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-08-30

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:75906d1f-930c-4b5c-b188-807c76c2d91a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049182
  • UPC Code
  • 0036800215573
  • NDC Crossover Matching brand name "Congestion PE" or generic name "Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    36800-331Congestion PECongestion PE
    72036-131Congestion PECongestion PE
    46994-953Congestion PECongestion PE
    0067-20864 WayPhenylephrine hydrochloride
    0113-7094basic care sinus pePhenylephrine Hydrochloride
    0363-0390ephrine nosePhenylephrine hydrochloride
    0363-2023Ephrine Nose DropsPhenylephrine hydrochloride
    0113-0094Good Sense Nasal Decongestant PEPhenylephrine Hydrochloride
    0113-0648Good Sense Nasal FourPhenylephrine hydrochloride
    0295-1217Little Remedies Decongestant Nose DropsPhenylephrine Hydrochloride
    0363-0717nasalPhenylephrine hydrochloride
    0295-1117Neo-SynephrinePhenylephrine hydrochloride
    0295-1118Neo-SynephrinePhenylephrine hydrochloride
    0295-1119Neo-SynephrinePhenylephrine hydrochloride
    0225-0800Neo-Synephrine MildPHENYLEPHRINE HYDROCHLORIDE
    0225-0805Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDE
    0225-0810Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDE
    0363-0394phenylephrine hydrochloridephenylephrine hydrochloride
    0404-9931Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6142Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6188Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6189Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6229Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0781-3422Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0781-3458Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0113-2004sinus PEPhenylephrine Hydrochloride
    0363-0648Wal FourPhenylephrine hydrochloride

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