NDC 58809-940

TexaClear Kids Congestion Stuffy Nose

Phenylephrine Hydrochloride

TexaClear Kids Congestion Stuffy Nose is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Phenylephrine Hydrochloride.

Product ID58809-940_33f5ba50-dd67-404e-a085-131ab89b1d7b
NDC58809-940
Product TypeHuman Otc Drug
Proprietary NameTexaClear Kids Congestion Stuffy Nose
Generic NamePhenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2019-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGM Pharmaceuticals, INC
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength3 mg/15mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 58809-940-08

24 BOTTLE in 1 BOX (58809-940-08) > 237 mL in 1 BOTTLE
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-940-08 [58809094008]

TexaClear Kids Congestion Stuffy Nose LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/15mL

OpenFDA Data

SPL SET ID:46ee7b0a-4d5d-48f6-a855-79c81ee9ac6a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2282010
  • NDC Crossover Matching brand name "TexaClear Kids Congestion Stuffy Nose" or generic name "Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    58809-940TexaClear Kids Congestion Stuffy NoseTexaClear Kids Congestion Stuffy Nose
    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.