ROBAFEN COUGH FORMULA

Product NDC: 0904-0061
11-digit product format: 009040061
Labeler code: 0904
Product ID: 0904-0061_93c5eb05-cf18-4dda-e053-2a95a90a874f
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: SYRUP
Route: ORAL
Labeler: Major Pharmaceuticals
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-08-15
Marketing end: 2020-09-30
Substance: GUAIFENESIN
Active strength: 100 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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0904-0061		D	Discontinued by firm	2026-10-05
excluded product	product	0904-0061		D	Discontinued by firm	2026-10-05
excluded product	product	0904-0061		D	Discontinued by firm	2026-10-05
excluded package	package	0904-0061	0904-0061-00	D	Discontinued by firm	2026-10-05
excluded package	package	0904-0061	0904-0061-09	D	Discontinued by firm	2026-10-05
excluded package	package	0904-0061	0904-0061-16	D	Discontinued by firm	2026-10-05
excluded package	package	0904-0061	0904-0061-20	D	Discontinued by firm	2026-10-05
excluded package	package	0904-0061	0904-0061-20	D	Discontinued by firm	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 2 · 96 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
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	0904-0061-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-0061-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-0061-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-0061-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-0061-20	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
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	0904-0061-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-0061-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-0061-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-0061-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-0061-20	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
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	0904-0061-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-0061-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-0061-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-0061-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-0061-20	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
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	0904-0061-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-0061-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-0061-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-0061-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-0061-20	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
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	0904-0061-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-0061-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-0061-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-0061-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-0061-20	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
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	0904-0061-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-0061-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-0061-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-0061-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-0061-20	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
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	0904-0061-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-0061-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-0061-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-0061-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-0061-20	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
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	0904-0061-16	`ed331223b511…`	`672a5bd82f5f…`

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
0904-0061-00	ML - Milliliter	0904-0061	ab74a419-4d6e-4e23-9a99-1f393c107cc2	1	2013-08-02
0904-0061-09	ML - Milliliter	0904-0061	70451862-9fed-4bf4-b236-a2f6f9fab1fd	1	2012-07-24
0904-0061-16	ML - Milliliter	0904-0061	5cef9570-dca3-44fb-9657-497b39927422	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [MAJOR PHARMACEUTICALS]	2
Guaifenesin	ACTIVE MOIETY	495W7451VQ	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [MAJOR PHARMACEUTICALS]	2
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [MAJOR PHARMACEUTICALS]	2
Caramel	INACTIVE INGREDIENT	T9D99G2B1R	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [MAJOR PHARMACEUTICALS]	2
Corn Syrup	INACTIVE INGREDIENT	9G5L16BK6N	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [MAJOR PHARMACEUTICALS]	2
FD&C Red no. 40	INACTIVE INGREDIENT	WZB9127XOA	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [MAJOR PHARMACEUTICALS]	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [MAJOR PHARMACEUTICALS]	2
Menthol	INACTIVE INGREDIENT	L7T10EIP3A	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [MAJOR PHARMACEUTICALS]	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [MAJOR PHARMACEUTICALS]	2
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [MAJOR PHARMACEUTICALS]	2
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [MAJOR PHARMACEUTICALS]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [MAJOR PHARMACEUTICALS]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1
CORN SYRUP	INACTIVE INGREDIENT	9G5L16BK6N	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	f73e1db1-cd54-4e1e-a739-4be0d73ac4a6	2
213155	Robafen 200 MG in 10 mL Oral Solution	PSN	f73e1db1-cd54-4e1e-a739-4be0d73ac4a6	2
213155	guaifenesin 20 MG/ML Oral Solution [Robafen]	SBD	f73e1db1-cd54-4e1e-a739-4be0d73ac4a6	2
310604	guaifenesin 20 MG/ML Oral Solution	SCD	f73e1db1-cd54-4e1e-a739-4be0d73ac4a6	2
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	f73e1db1-cd54-4e1e-a739-4be0d73ac4a6	2
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	f73e1db1-cd54-4e1e-a739-4be0d73ac4a6	2
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	f73e1db1-cd54-4e1e-a739-4be0d73ac4a6	2
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	f73e1db1-cd54-4e1e-a739-4be0d73ac4a6	2
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	f73e1db1-cd54-4e1e-a739-4be0d73ac4a6	2
213155	Robafen 100 MG per 5 mL Oral Solution	SY	f73e1db1-cd54-4e1e-a739-4be0d73ac4a6	2
213155	Robafen 200 MG per 10 mL Oral Solution	SY	f73e1db1-cd54-4e1e-a739-4be0d73ac4a6	2
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	a925e169-a63d-4614-925e-e556daef9ec5	1
213155	Robafen 200 MG in 10 mL Oral Solution	PSN	a925e169-a63d-4614-925e-e556daef9ec5	1
213155	guaifenesin 20 MG/ML Oral Solution [Robafen]	SBD	a925e169-a63d-4614-925e-e556daef9ec5	1
310604	guaifenesin 20 MG/ML Oral Solution	SCD	a925e169-a63d-4614-925e-e556daef9ec5	1
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	a925e169-a63d-4614-925e-e556daef9ec5	1
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	a925e169-a63d-4614-925e-e556daef9ec5	1
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	a925e169-a63d-4614-925e-e556daef9ec5	1
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	a925e169-a63d-4614-925e-e556daef9ec5	1
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	a925e169-a63d-4614-925e-e556daef9ec5	1
213155	Robafen 100 MG per 5 mL Oral Solution	SY	a925e169-a63d-4614-925e-e556daef9ec5	1
213155	Robafen 200 MG per 10 mL Oral Solution	SY	a925e169-a63d-4614-925e-e556daef9ec5	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Robafen™ Syrup	Major Pharmaceuticals	2019-09-30	HUMAN OTC DRUG LABEL	5
Robafen™ Syrup	REMEDYREPACK INC.	2017-10-05	HUMAN OTC DRUG LABEL	2
Robafen™ Syrup	NuCare Pharmceuticals,Inc.	2017-09-14	HUMAN OTC DRUG LABEL	1
ROBAFEN™ COUGH FORMULA	Aidarex Pharmaceuticals LLC	2013-10-03	HUMAN OTC DRUG LABEL	1