NDC 52083-679

G-TRON PEDIATRIC DROPS

Dextromethorphan Hbr,guaifenesin,phenylephrine Hcl

G-TRON PEDIATRIC DROPS is a Nasal Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID52083-679_b60138fe-f319-4ed1-b13a-5ce5d0cbcce8
NDC52083-679
Product TypeHuman Otc Drug
Proprietary NameG-TRON PEDIATRIC DROPS
Generic NameDextromethorphan Hbr,guaifenesin,phenylephrine Hcl
Dosage FormSolution/ Drops
Route of AdministrationNASAL
Marketing Start Date2014-09-09
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKRAMER NOVIS
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52083-679-01

30 mL in 1 BOTTLE, DROPPER (52083-679-01)
Marketing Start Date2014-09-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-679-01 [52083067901]

G-TRON PEDIATRIC DROPS SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-09-09

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/mL

OpenFDA Data

SPL SET ID:c3881560-a16d-492a-b2f3-032927cf890d
Manufacturer
UNII

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