NDC 83057-0001

Novalgina Children Cough and Cold

Acetaminofen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Novalgina Children Cough and Cold is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by La Botica Imports. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID83057-0001_eb3f0cb2-03d5-1776-e053-2a95a90acf37
NDC83057-0001
Product TypeHuman Otc Drug
Proprietary NameNovalgina Children Cough and Cold
Generic NameAcetaminofen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2022-11-01
Marketing CategoryOTC MONOGRAPH FINAL /
Application Numberpart341
Labeler NameLa Botica Imports
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength250 mg/10mL; mg/10mL; mg/10mL; mg/10mL
Pharm ClassesAdrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 83057-0001-6

1 BOTTLE in 1 CARTON (83057-0001-6) > 180 mL in 1 BOTTLE
Marketing Start Date2022-11-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Novalgina Children Cough and Cold" or generic name "Acetaminofen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

NDCBrand NameGeneric Name
70242-102BroncomarAcetaminofen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
53149-2002NovalginaAcetaminofen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
83057-0001NovalginaAcetaminofen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

Trademark Results [Novalgina]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOVALGINA
NOVALGINA
98704743 not registered Live/Pending
A. Nattermann & Cie. GmbH
2024-08-19
NOVALGINA
NOVALGINA
88616242 not registered Live/Pending
Aracely Express Corp.
2019-09-13

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