cough and chest congestion DM syrup

Product NDC: 68071-2861
Requested package NDC: 68071-2861-4
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-2861	68071-2861-4	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

DailyMed Package Descriptions#

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

DailyMed Dashboard NDC Coverage#

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

DailyMed RxNorm Mappings#

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

Packages#

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