Novalgina

Product NDC: 83057-0001
11-digit product format: 830570001
Labeler code: 83057
Product ID: 83057-0001_eb3f0cb2-03d5-1776-e053-2a95a90acf37
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminofen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: La Botica Imports
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-11-01
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 250 mg/10mL; mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes: Adrenergic 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 flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83057-0001-6	NovalginaChildren Cough and Cold	180 mL in 1 BOTTLE	LIQUID	180		4
83057-0001-6	NovalginaChildren Cough and Cold	1 in 1 CARTON	LIQUID	1		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83057-0001	NOVALGINA CHILDREN COUGH AND COLD (ACETAMINOFEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [HBC PHARMA, LLC]	4	Legacy NDC, 2 package rows	20241105_eb3f0cb2-03d4-1776-e053-2a95a90acf37.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1790651	acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution	PSN	eb3f0cb2-03d4-1776-e053-2a95a90acf37	4
1790651	acetaminophen 25 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	eb3f0cb2-03d4-1776-e053-2a95a90acf37	4
1790651	acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	eb3f0cb2-03d4-1776-e053-2a95a90acf37	4
1790651	acetaminophen 500 MG / dextromethorphan HBr 26.66 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	eb3f0cb2-03d4-1776-e053-2a95a90acf37	4
1790651	APAP 25 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution	SY	eb3f0cb2-03d4-1776-e053-2a95a90acf37	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
83057-0001-6	83057000106	1 BOTTLE in 1 CARTON (83057-0001-6) > 180 mL in 1 BOTTLE	1 bottle	2022-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Novalgina Children Cough and Cold	HBC Pharma, LLC \| GADAL Laboratories, Inc	2024-11-04	HUMAN OTC DRUG LABEL	4