Tusnel

Product NDC: 54859-507
11-digit product format: 548590507
Labeler code: 54859
Product ID: 54859-507_471f0d89-3e44-8d6d-e063-6294a90a508d
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: Llorens Pharmaceutical International Division, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-05-01
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: Tusnel
Brand name suffix: EX
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
77c16288-68c4-476c-995f-86f505663270	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54859-507-04	TusnelEX	118 mL in 1 BOTTLE	LIQUID	118		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-507-04	ML - Milliliter	54859-507	5c55f5ab-24dd-43cb-8a84-9705b69eb110	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54859-507	TUSNEL EX (GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20241225_77c16288-68c4-476c-995f-86f505663270.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 177 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief Immediate Release	GUAIFENESIN 400MG	TopCo Associates, LLC	7d91c6ab-d161-42b9-b353-0aa8f59619f8	2021-01-21	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG	Allegiant Health	bed5f9dc-45ea-4e90-86c6-86599b6f3861	2020-11-16	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN	Allegiant Health	b97126d7-847d-483e-b3d1-e2b61ab1743f	2020-11-11	Warnings	Exact identifier application number: M012
Cold and Allergy	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Allegiant Health	7af63769-fa56-4f1f-a2ad-5b4c108c8e4f	2019-12-12	Warnings	Exact identifier application number: M012
Mucus Relief Immediate Release	GUAIFENESIN	Allegiant Health	221d64a2-b8c7-435a-aae4-fb58fd38108f	2019-03-26	Warnings	Exact identifier application number: M012
Sleep Tabs For Nighttime use	DIPHENHYDRAMINE HCL TABLETS	Allegiant Health	566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	2018-12-26	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	Allegiant Health	4305ad50-d2a5-4d3e-9d92-cbf26e856a16	2018-12-26	Warnings	Exact identifier application number: M012
Sleep Aid	DIPHENHYDRAMINE HCL 25 MG	Allegiant Health	dbbc535f-515a-4d9b-b799-34e60f5230bb	2018-12-21	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	Allegiant Health	c2823bad-540f-4662-8dcc-58e9f0d94efb	2018-11-07	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength Non-Drowsy	PHENYLEPHRINE 10 MG	Allegiant Health	7aef00df-816a-4ea2-a2ad-beed66dd2fe4	2018-11-07	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	a58bfb14-28f9-4425-a5a5-aaff4847c979	2018-03-14	Warnings	Exact identifier application number: M012
Chlorpheniramine maleate 4mg	CHLORPHENIRAMINE MALEATE 4MG	Athlete's Needs, Inc.	4d974959-25fc-4707-9b72-9afbf47b76f1	2017-11-14	Warnings	Exact identifier application number: M012
Cold Medicine	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Selder, S.A. de C.V.	d2762d9c-e7e7-42b2-a26a-14b2aa0307cb	2017-01-25	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	Marc Glassman, Inc.	2051247f-ce64-4cf5-b449-9ca14c43ab86	2016-12-27	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	7f703c9c-2256-4524-9d31-c51919399d26	8
310604	guaifenesin 20 MG/ML Oral Solution	SCD	7f703c9c-2256-4524-9d31-c51919399d26	8
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	7f703c9c-2256-4524-9d31-c51919399d26	8
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	7f703c9c-2256-4524-9d31-c51919399d26	8
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	7f703c9c-2256-4524-9d31-c51919399d26	8
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	7f703c9c-2256-4524-9d31-c51919399d26	8
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	7f703c9c-2256-4524-9d31-c51919399d26	8
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	77c16288-68c4-476c-995f-86f505663270	6
310604	guaifenesin 20 MG/ML Oral Solution	SCD	77c16288-68c4-476c-995f-86f505663270	6
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	77c16288-68c4-476c-995f-86f505663270	6
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	77c16288-68c4-476c-995f-86f505663270	6
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	77c16288-68c4-476c-995f-86f505663270	6
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	77c16288-68c4-476c-995f-86f505663270	6
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	77c16288-68c4-476c-995f-86f505663270	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54859-507-04	54859050704	118 mL in 1 BOTTLE (54859-507-04)	118 ml	2019-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Llorens-TusnelEX 507	A-S Medication Solutions	2026-03-03	HUMAN OTC DRUG LABEL	8
Llorens-TusnelEX 507	Llorens Pharmaceutical International Division, Inc.	2025-12-29	HUMAN OTC DRUG LABEL	6