Robafen DM Cough Sugar Free Clear

Product NDC: 0904-6306
11-digit product format: 009046306
Labeler code: 0904
Product ID: 0904-6306_9363c835-c994-159e-e053-2995a90a607b
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Dextromethorphan Hydrobromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Major Pharmaceuticals
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-12-20
Marketing end: 2020-04-30
Substance: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 100 mg/5mL; mg/5mL
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-6306		D	Discontinued by firm		2026-10-12
excluded package	package	0904-6306	0904-6306-20	D	Discontinued by firm		2026-10-12

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-6306-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-6306-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-6306-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-6306-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-6306-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-6306-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-6306-20	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0904-6306-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0904-6306-20	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0904-6306-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0904-6306-20	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0904-6306-20	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6306-20	ML - Milliliter	0904-6306	5d14d06c-f4e4-41c1-babf-c3e7cf0e3ad1	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Menthol	INACTIVE INGREDIENT	L7T10EIP3A	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Povidones	INACTIVE INGREDIENT	FZ989GH94E	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Prunus Serotina Bark	INACTIVE INGREDIENT	5D48E975HA	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	ROBAFEN DM COUGH SUGAR FREE CLEAR (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]	1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	ab0f8f18-cce4-41e9-957e-e9396966094a	3
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	ab0f8f18-cce4-41e9-957e-e9396966094a	3
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	ab0f8f18-cce4-41e9-957e-e9396966094a	3
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	ab0f8f18-cce4-41e9-957e-e9396966094a	3
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	ab0f8f18-cce4-41e9-957e-e9396966094a	3

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Robafen ® DM Cough Sugar Free Clear	Major Pharmaceuticals	2019-09-25	HUMAN OTC DRUG LABEL	5
Robafen DM Cough Sugar Free Clear ®	Atlantic Biologicals Corps	2016-07-22	HUMAN OTC DRUG LABEL	3