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 147 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold Multi-Symptom Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Marc Glassman, Inc.	ce573785-f77d-4314-9b7a-ef3f1f4f34d8	2024-10-23	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e41a3dcc-45b4-4093-e053-2995a90a3b14	2024-10-23	Warnings	Exact identifier application number: M012
Cold plus Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e41a7cc5-bd0e-b92b-e053-2995a90af50a	2024-10-23	Warnings	Exact identifier application number: M012
Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Kroger Company	1cd26a6a-4b50-4610-9fc8-278545d77f18	2024-10-23	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy	c5dd40e5-b4e2-4963-9a53-b71da1ed5510	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	832eb36c-21c6-46d7-b1f8-ab8b6f1e501e	2024-10-22	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	c9d82968-b2ec-2f4b-e053-2a95a90a7f0c	2024-10-22	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	b9d9ab99-44b1-455f-a29a-95c193a4808e	2024-10-22	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HARRIS TEETER	b96c376e-578f-1124-e053-2a95a90acbb4	2024-10-22	Warnings	Exact identifier application number: M012
Tukol Honey Daytime and Nighttime Value Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	Genomma Lab USA	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	2024-10-22	Warnings	Exact identifier application number: M012
Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	c92b508b-e5f9-4149-8c4b-d21845943b3b	2024-10-22	Warnings	Exact identifier application number: M012
Cold Flu Severe Day Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	2924a691-b352-4263-b6ba-9ab97e95e2a5	2024-10-22	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HARRIS TEETER	b2091281-a64a-190a-e053-2995a90a890a	2024-10-22	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HBR, GUAIFENESIN	Safeway	cf04bdf7-fed4-4f06-a193-f2e83fcc531c	2024-10-22	Warnings	Exact identifier application number: M012
Tukol Honey Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	c9572b16-8e28-4f98-bd87-8a07721a49c6	2024-10-21	Warnings	Exact identifier application number: M012
Tukol Honey Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Genomma Lab USA	bf25f38e-3549-4f78-be90-46605b5f2c11	2024-10-21	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	HEB	b5a6719e-746b-58ec-e053-2a95a90af010	2024-10-21	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	a6cdc084-c23b-e733-e053-2995a90a3506	2024-10-21	Warnings	Exact identifier application number: M012
Cold Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	ea39a67d-8a99-4f7c-9925-94b07d0b1092	2024-10-21	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HEB	eb7920a3-3c25-6aa1-e053-2995a90ac2b9	2024-10-21	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