Ritussin Expectorant

Product NDC: 53807-408
11-digit product format: 538070408
Labeler code: 53807
Product ID: 53807-408_fc28d7de-7f4e-4327-9101-d33680f8d5c8
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN
Dosage form: LIQUID
Route: ORAL
Labeler: Rij Pharmaceutical Corporation
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1999-03-16
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53807-408		I	Inactivated by FDA	2026-11-13
excluded package	package	53807-408	53807-408-04	I	Inactivated by FDA	2026-11-13
excluded package	package	53807-408	53807-408-08	I	Inactivated by FDA	2026-11-13
excluded package	package	53807-408	53807-408-16	I	Inactivated by FDA	2026-11-13
excluded package	package	53807-408	53807-408-28	I	Inactivated by FDA	2026-11-13

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 · 105 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	53807-408-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53807-408-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53807-408-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53807-408-16	`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	53807-408-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53807-408-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53807-408-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53807-408-16	`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	53807-408-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53807-408-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53807-408-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53807-408-16	`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	53807-408-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53807-408-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53807-408-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53807-408-16	`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	53807-408-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53807-408-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53807-408-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53807-408-16	`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	53807-408-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53807-408-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53807-408-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53807-408-16	`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	53807-408-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53807-408-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53807-408-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53807-408-16	`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	53807-408-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53807-408-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53807-408-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53807-408-16	`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	53807-408-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53807-408-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53807-408-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53807-408-16	`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	53807-408-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53807-408-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53807-408-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53807-408-16	`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	53807-408-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53807-408-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53807-408-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53807-408-16	`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	53807-408-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53807-408-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53807-408-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53807-408-16	`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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
53807-408-04	Drug Facts
53807-408-08	Drug Facts
53807-408-16	Drug Facts
53807-408-28	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53807-408-04	Ritussin Expectorant	118 mL in 1 BOTTLE	LIQUID	118	2
53807-408-08	Ritussin Expectorant	236 mL in 1 BOTTLE	LIQUID	236	2
53807-408-16	Ritussin Expectorant	473 mL in 1 BOTTLE	LIQUID	473	2
53807-408-28	Ritussin Expectorant	3785 mL in 1 BOTTLE	LIQUID	3785	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53807-408	RITUSSIN EXPECTORANT (GUAIFENESIN) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	2	Legacy NDC, 4 package rows	20180502_e89aed0d-fff1-4781-bdd9-ac614457c1f6.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	e89aed0d-fff1-4781-bdd9-ac614457c1f6	2
310604	guaifenesin 20 MG/ML Oral Solution	SCD	e89aed0d-fff1-4781-bdd9-ac614457c1f6	2
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	e89aed0d-fff1-4781-bdd9-ac614457c1f6	2
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	e89aed0d-fff1-4781-bdd9-ac614457c1f6	2
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	e89aed0d-fff1-4781-bdd9-ac614457c1f6	2
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	e89aed0d-fff1-4781-bdd9-ac614457c1f6	2
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	e89aed0d-fff1-4781-bdd9-ac614457c1f6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53807-408-04	53807040804	118 mL in 1 BOTTLE	118 ml	Historical
53807-408-08	53807040808	236 mL in 1 BOTTLE	236 ml	Historical
53807-408-16	53807040816	473 mL in 1 BOTTLE	473 ml	Historical
53807-408-28	53807040828	3785 mL in 1 BOTTLE	3785 ml	Historical