NDC 58238-230

TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor

Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride

TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Deliz Pharmaceutical Corp. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Pseudoephedrine Hydrochloride.

Product ID58238-230_1e66114f-db78-443f-e054-00144ff8d46c
NDC58238-230
Product TypeHuman Otc Drug
Proprietary NameTRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor
Generic NameDextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2014-02-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDeliz Pharmaceutical Corp
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58238-230-02

1 BOTTLE in 1 CARTON (58238-230-02) > 60 mL in 1 BOTTLE
Marketing Start Date2014-02-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58238-230-02 [58238023002]

TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-02-27
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL

OpenFDA Data

SPL SET ID:b4630613-c78c-4f97-bd6c-0476899f5b90
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1435143
  • NDC Crossover Matching brand name "TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor" or generic name "Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    58238-230TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE FlavorDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
    29978-606CAPMISTDextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride
    52083-648DESGEN DM TabsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
    52083-628PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE FlavorDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
    58238-228TRISPEC PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE FlavorDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE

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