NDC 36800-094

TopCare Nasal Decongestant PE

Phenylephrine Hydrochloride

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

Product ID36800-094_2886e45d-ddcc-4f3b-ae88-26d7e5c528f8
NDC36800-094
Product TypeHuman Otc Drug
Proprietary NameTopCare Nasal Decongestant PE
Generic NamePhenylephrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-09-12
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 Through2022-12-31

Packaging

NDC 36800-094-23

12 BLISTER PACK in 1 CARTON (36800-094-23) > 6 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2005-09-19
Marketing End Date2022-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-094-47 [36800009447]

TopCare Nasal Decongestant PE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2009-02-03
Marketing End Date2011-07-02

NDC 36800-094-89 [36800009489]

TopCare Nasal Decongestant PE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2005-09-12

NDC 36800-094-68 [36800009468]

TopCare Nasal Decongestant PE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2005-09-13

NDC 36800-094-23 [36800009423]

TopCare Nasal Decongestant PE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2005-09-19

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:1a903229-a8c5-40ff-86af-737e77c8feec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049182
  • Medicade Reported Pricing

    36800094940 MILK OF MAGNESIA SUSPENSION

    Pricing Unit: ML | Drug Type:

    36800094610 INFANT PAIN-FEVER 160 MG/5 ML

    Pricing Unit: ML | Drug Type:

    36800094424 HEMORRHOIDAL CREAM

    Pricing Unit: GM | Drug Type:

    36800009489 NASAL DECONGESTANT PE 10 MG TB

    Pricing Unit: EA | Drug Type:

    36800009468 NASAL DECONGESTANT PE 10 MG TB

    Pricing Unit: EA | Drug Type:

    36800009447 NASAL DECONGESTANT PE 10 MG TB

    Pricing Unit: EA | Drug Type:

    36800009423 NASAL DECONGESTANT PE 10 MG TB

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "TopCare Nasal Decongestant PE" or generic name "Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    36800-094TopCare Nasal Decongestant PETopCare Nasal Decongestant 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

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