Guaifenesin

Product NDC: 69618-061
11-digit product format: 696180061
Labeler code: 69618
Product ID: 69618-061_2bc81e27-90e3-930d-e063-6394a90a699d
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET
Route: ORAL
Labeler: Reliable 1 Laboratories LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-08-01
Substance: GUAIFENESIN
Active strength: 400 mg/1
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	400 mg/1

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
359601	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
ae469d4f-91c4-cff0-e053-2995a90a0497	Available on FDA.report

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
69618-061-06	2023-03-29	C162847	48780-1	f386c649-d238-0266-e053-dadaa90a7c1a	Guifenisen 400 mg
69618-061-06	2023-01-30	C162847	48780-1	f386c649-d238-0266-e053-dadaa90a7c1a	Guifenisen 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69618-061-06	Guaifenesin	60 in 1 BOTTLE, PLASTIC	TABLET	60		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69618-061-06	EA - Each	69618-061	9467aaf0-ae81-4301-a553-1077f9182d44	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69618-061	GUAIFENESIN TABLET [RELIABLE 1 LABORATORIES LLC]	5	Current NDC, Legacy NDC, 1 package rows	20250117_ae469d4f-91c4-cff0-e053-2995a90a0497.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 122 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a	2025-01-26	Warnings	Exact identifier application number: M012
Walgreens Menthol Cough Drops	MENTHOL	Walgreens	2c62f690-8dfb-d28e-e063-6394a90a45a2	2025-01-23	Warnings	Exact identifier application number: M012
Walgreens Cherry Cough Drops	MENTHOL	Walgreens	2c65d836-e724-50d6-e063-6394a90a0827	2025-01-23	Warnings	Exact identifier application number: M012
Walgreens Honey Lemon Cough Drops	MENTHOL	Walgreens	2c67424c-2fb0-cc15-e063-6394a90a02ca	2025-01-23	Warnings	Exact identifier application number: M012
Pharmacys Prescription Analgesic Gel	MENTHOL	American Consumer Products Corp	6f0725f2-833f-f3a0-e053-2a91aa0a3911	2025-01-23	Warnings	Exact identifier application number: M012
Pharmacys Prescription Vapor Rub	MENTHOL	American Consumer Products Corp	6ef328ff-f5c3-515d-e053-2a91aa0a32d3	2025-01-23	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Best Choice	0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d	2025-01-22	Warnings	Exact identifier application number: M012
GOOD REMEDIES Allergy Relief SOFTGEL	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	26a02737-2cfd-769f-e063-6394a90af352	2025-01-22	Warnings	Exact identifier application number: M012
Pharbechlor	CHLORPHENIRAMINE MALEATE 4MG	Ulai Health LLC	6a1a5cef-e946-4ba8-9402-557c6adf45f9	2025-01-20	Warnings	Exact identifier application number: M012
Pharbinex	GUAIFENESIN 400MG	Ulai Health LLC	4eafa81a-aeee-4c97-85d6-594902b10919	2025-01-20		Exact identifier application number: M012
Pharbinex-PE	GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG	Ulai Health LLC	e459bb83-b1d6-42fc-aa46-99ad117e6144	2025-01-20		Exact identifier application number: M012
Pharbinex-DM	GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG	Ulai Health LLC	af80d10e-3fb2-405a-a803-1f876b8dcd10	2025-01-20		Exact identifier application number: M012
Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Bayer HealthCare LLC.	34b2e77f-5d04-15a7-e054-00144ff8d46c	2025-01-17	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	a23a6db6-4585-2882-e053-2a95a90ab01a	2025-01-17	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	fc754dff-cecd-fc6b-e053-6394a90ab371	2025-01-17	Warnings	Exact identifier application number: M012
Kroger DayTime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	The Kroger Co.	2499210b-c162-76b9-e063-6294a90adbc3	2025-01-17	Warnings	Exact identifier application number: M012
Childrens Multi Symptom Cold Very Berry	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS	2a849ae9-338f-4642-e063-6394a90a1ca4	2025-01-17	Warnings	Exact identifier application number: M012
Kroger NightTime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	The Kroger Co.	24a73de3-e9eb-4cd4-e063-6394a90aa263	2025-01-17	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HCL ORAL	Everpharm LLC	d7aaf874-69ac-49cf-93be-6d4a38b9a557	2025-01-16	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HBR	Best Choice (Valu Merchandisers Company)	204a7fc4-142d-45fd-8a77-0612857132be	2025-01-16	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
359601	guaiFENesin 400 MG Oral Tablet	PSN	570a71eb-2d19-4c7b-8c00-e1524bfa3844	102
359601	guaifenesin 400 MG Oral Tablet	SCD	570a71eb-2d19-4c7b-8c00-e1524bfa3844	102
359601	guaiFENesin 400 MG Oral Tablet	PSN	ae469d4f-91c4-cff0-e053-2995a90a0497	5
359601	guaifenesin 400 MG Oral Tablet	SCD	ae469d4f-91c4-cff0-e053-2995a90a0497	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69618-061-06	69618006106	60 TABLET in 1 BOTTLE, PLASTIC (69618-061-06)	60 tablet	2020-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guifenisen 400 mg	Bryant Ranch Prepack	2025-03-31	HUMAN OTC DRUG LABEL	102
Guifenisen 400 mg	Reliable 1 Laboratories LLC	2025-01-15	HUMAN OTC DRUG LABEL	5