Guaifenesin

Product NDC: 58657-508
11-digit product format: 586570508
Labeler code: 58657
Product ID: 58657-508_41b51a4b-65a5-778b-e063-6294a90ae4a9
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: Method Pharmaceuticals, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-04-01
Substance: GUAIFENESIN
Active strength: 100 mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Guaifenesin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310604	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1539c3d4-d982-7d4e-e063-6394a90ad7d6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58657-508-16	Guaifenesin	473 mL in 1 BOTTLE	LIQUID	473		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58657-508-16	ML - Milliliter	58657-508	6867c51f-6f8f-4f97-b3cd-09026f75630c	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58657-508	GUAIFENESIN LIQUID [METHOD PHARMACEUTICALS, LLC]	2	Current NDC, 1 package rows	20240509_1539c3d4-d982-7d4e-e063-6394a90ad7d6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 155 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nasal decongestant maximum strength non drowsy	PSEUDOEPHEDRINE HCL	Meijer Distribution Inc	8a68ca99-fd76-409a-9769-88830e8720a8	2024-09-28	Warnings	Exact identifier application number: M012
good neighbor pharmacy tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	58687394-b6d2-4d51-bde0-8f2cfa3fe909	2024-09-27	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal	OXYMETAZOLINE HYDROCHLORIDE	Amerisource Bergen	faee3aae-e819-4084-a127-3449be353b13	2024-09-27	Warnings	Exact identifier application number: M012
Tesalon Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL	OPMX LLC	2309620a-ccbc-41e9-e063-6394a90a9520	2024-09-26	Warnings	Exact identifier application number: M012
adult cough and chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Meijer, Inc.	b11c4cee-bbb5-4585-9d38-6787553e13a0	2024-09-26	Warnings	Exact identifier application number: M012
COLD AND FLU NIGHTTIME SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9c34e-a0ca-cdf9-e053-2a95a90a93d3	2024-09-25	Warnings	Exact identifier application number: M012
Basic Care Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	8f3317f6-4ae8-474b-93c3-25e256519cb8	2024-09-25	Warnings	Exact identifier application number: M012
berkley and jensen tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	BJWC	b2de91c9-6af0-4881-8d2d-a69d90c8dfcd	2024-09-24	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest Non Drowsy	DEXTROMETHORPHAN HBR, GUAIFENESIN	WinCo Foods, LLC	13eb459c-3075-4038-8062-9ee7175b2ab9	2024-09-24	Warnings	Exact identifier application number: M012
equaline nasal decongestant non drowsy maximum strength	PSEUDOEPHEDRINE HCL	United Natural Foods, Inc. dba UNFI	8897580a-709a-4643-8264-ad003d90cbff	2024-09-22	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Dabur India Limited	22916978-303d-e62a-e063-6394a90a2100	2024-09-20	Warnings	Exact identifier application number: M012
Topcare Nasal Decongestant Maximum Strength Non Drowsy	PSEUDOEPHEDRINE HCL	Topco Associates LLC	1a9e0336-c0c2-43f8-aeea-668d4a209714	2024-09-20	Warnings	Exact identifier application number: M012
Leader Nasal Decongestant	PSEUDOEPHEDRINE HCL	Cardinal Health 110, LLC. dba Leader	25609b66-047c-46e7-bc95-20eb8e6c9617	2024-09-20	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	CVS Pharmacy	bebe5e78-09ba-4d35-9d34-9f5e34341478	2024-09-20	Warnings	Exact identifier application number: M012
equaline nasal	PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	67fdd277-7a7a-4404-8ca2-39802c46405f	2024-09-20	Warnings	Exact identifier application number: M012
equaline tussin	DEXTROMETHORPHAN HBR, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	8bc7fa7c-d565-48c9-9808-1042c3e9d428	2024-09-20	Warnings	Exact identifier application number: M012
Leader Adult Tussin Mucus and Chest Congestion 541	GUAIFENESIN	CARDINAL HEALTH 110, LLC. DBA LEADER	d7fae410-9c1c-4231-9fde-2c51ad3d7e95	2024-09-20	Warnings	Exact identifier application number: M012
sinus	PSEUDOEPHEDRINE HYDROCHLORIDE	Kroger Company	18812f2a-9b66-45a7-9631-123da6fd1c1f	2024-09-20	Warnings	Exact identifier application number: M012
Good Sense Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	930469c1-384c-4440-b3e6-9dcd674871c4	2024-09-19	Warnings	Exact identifier application number: M012
Cold and Flu Relief Multi Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	WinCo Foods, LLC	89272d2d-5533-4ae8-865b-cb204cec6d65	2024-09-17	Warnings	Exact identifier application number: M012

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	1e9887f6-209f-4f1f-9afa-a5ca649721cb	5
310604	guaifenesin 20 MG/ML Oral Solution	SCD	1e9887f6-209f-4f1f-9afa-a5ca649721cb	5
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	1e9887f6-209f-4f1f-9afa-a5ca649721cb	5
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	1e9887f6-209f-4f1f-9afa-a5ca649721cb	5
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	1e9887f6-209f-4f1f-9afa-a5ca649721cb	5
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	1e9887f6-209f-4f1f-9afa-a5ca649721cb	5
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	1e9887f6-209f-4f1f-9afa-a5ca649721cb	5
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	1539c3d4-d982-7d4e-e063-6394a90ad7d6	3
310604	guaifenesin 20 MG/ML Oral Solution	SCD	1539c3d4-d982-7d4e-e063-6394a90ad7d6	3
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	1539c3d4-d982-7d4e-e063-6394a90ad7d6	3
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	1539c3d4-d982-7d4e-e063-6394a90ad7d6	3
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	1539c3d4-d982-7d4e-e063-6394a90ad7d6	3
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	1539c3d4-d982-7d4e-e063-6394a90ad7d6	3
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	1539c3d4-d982-7d4e-e063-6394a90ad7d6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58657-508-16	58657050816	473 mL in 1 BOTTLE (58657-508-16)	473 ml	2024-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin	Bryant Ranch Prepack	2026-03-18	HUMAN OTC DRUG LABEL	5
Guaifenesin	Method Pharmaceuticals, LLC	2025-10-21	HUMAN OTC DRUG LABEL	3