cough and chest congestion DM syrup

Product NDC: 68071-2861
11-digit product format: 680712861
Labeler code: 68071
Product ID: 68071-2861_ebf2aa18-96c9-085f-e053-2995a90af4ee
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan hydrobromide, guaifenesin
Dosage form: SOLUTION
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-01-07
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 20 mg/20mL; mg/20mL
Pharmacologic classes: 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]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2861-4	2025-01-30	C162847	48780-1	2cef2736-5b2f-d83d-e063-dadaa90ab31f	Rugby Laboratories Cough Syrup Drug Facts

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2861-4	cough and chest congestion DM syrup	1 in 1 CARTON	SOLUTION	1		1
68071-2861-4	cough and chest congestion DM syrup	118 mL in 1 BOTTLE	SOLUTION	118		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2861	COUGH AND CHEST CONGESTION DM SYRUP (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 2 package rows	20221029_ebf2a96b-0e5f-3f9b-e053-2995a90a1360.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1790650	dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution	PSN	ebf2a96b-0e5f-3f9b-e053-2995a90a1360	1
1790650	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution	SCD	ebf2a96b-0e5f-3f9b-e053-2995a90a1360	1
1790650	dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution	SY	ebf2a96b-0e5f-3f9b-e053-2995a90a1360	1
1790650	dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution	SY	ebf2a96b-0e5f-3f9b-e053-2995a90a1360	1
1790650	dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral Solution	SY	ebf2a96b-0e5f-3f9b-e053-2995a90a1360	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2861-4	68071286104	1 BOTTLE in 1 CARTON (68071-2861-4) > 118 mL in 1 BOTTLE	1 bottle	2022-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rugby Laboratories Cough Syrup Drug Facts	NuCare Pharmaceuticals,Inc.	2022-10-26	HUMAN OTC DRUG LABEL	1