Novalgina

Product NDC: 53149-2002
11-digit product format: 531492002
Labeler code: 53149
Product ID: 53149-2002_f959e3f4-4c31-42af-9974-2fbfc3199372
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminofen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: All Pharma LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2001-10-01
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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53149-2002-6	2023-07-28	C162847	48780-1	0191ceaa-6677-198a-e063-dbdaa90aec3e	Novalgina Children Cough and Cold

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53149-2002-6	NovalginaChildren Cough and Cold	177 mL in 1 BOTTLE	LIQUID	177		2
53149-2002-6	NovalginaChildren Cough and Cold	1 in 1 CARTON	LIQUID	1		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53149-2002	NOVALGINA CHILDREN COUGH AND COLD (ACETAMINOFEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALL PHARMA LLC]	2	Legacy NDC, 2 package rows	20220121_dcb06698-a546-4595-9cd0-26fd96a9be89.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	dcb06698-a546-4595-9cd0-26fd96a9be89	2
1790651	acetaminophen 25 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	dcb06698-a546-4595-9cd0-26fd96a9be89	2
1790651	acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	dcb06698-a546-4595-9cd0-26fd96a9be89	2
1790651	acetaminophen 500 MG / dextromethorphan HBr 26.66 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	dcb06698-a546-4595-9cd0-26fd96a9be89	2
1790651	APAP 25 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution	SY	dcb06698-a546-4595-9cd0-26fd96a9be89	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53149-2002-6	53149200206	1 BOTTLE in 1 CARTON (53149-2002-6) > 177 mL in 1 BOTTLE	1 bottle	2015-01-01	0000-00-00	No	No	Current