ROBAFEN COUGH FORMULA

Product NDC: 53217-024
11-digit product format: 532170024
Labeler code: 53217
Product ID: 53217-024_0b3cb041-1d4b-486d-937b-95e06b0b9882
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: SYRUP
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-08-15
Marketing end: 0000-00-00
Substance: GUAIFENESIN
Active strength: 100 mg/5mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53217-024		I	Inactivated by FDA		2026-10-05
excluded package	package	53217-024	53217-024-01	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 · 42 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	53217-024-01	`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	53217-024-01	`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	53217-024-01	`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	53217-024-01	`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	53217-024-01	`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	53217-024-01	`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	53217-024-01	`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	53217-024-01	`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	53217-024-01	`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	53217-024-01	`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	53217-024-01	`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	53217-024-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53217-024-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53217-024-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53217-024-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53217-024-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53217-024-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53217-024-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53217-024-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53217-024-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53217-024-01	`9bebd1f3094a…`	`5416666fcb17…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-024-01	2020-01-31	C162847	48780-1	9d75b9d0-cd66-f424-e053-dadaa90a57ce	ROBAFEN™ COUGH FORMULA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-024-01	ROBAFEN COUGH FORMULA	118 mL in 1 BOTTLE, PLASTIC	SYRUP	118		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-024-01	ML - Milliliter	53217-024	6ef514b9-d4a5-4d0f-9470-25553ccb31c4	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-024	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20140214_a925e169-a63d-4614-925e-e556daef9ec5.zip

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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53217-024-01	53217002401	118 mL in 1 BOTTLE, PLASTIC	118 ml	Historical