Tusnel

Product NDC: 54859-502
11-digit product format: 548590502
Labeler code: 54859
Product ID: 54859-502_474619be-1630-c769-e063-6394a90ac561
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan, Guiafenesin, Pseudoephedrine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: Llorens Pharmaceutical International Division
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-01-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 15; 200; 30 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 1 · 8 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
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54859-502-06	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54859-502-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54859-502-16	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54859-502-06	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54859-502-10	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54859-502-16	`9bebd1f3094a…`	`5416666fcb17…`

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL
GUAIFENESIN	200 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1098227	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
805dc611-355a-4af5-bf19-464c3290c5c6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
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
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
54859-502-06	2020-12-23	Llorens- Tusnel 502
54859-502-10	2020-12-23	Llorens- Tusnel 502
54859-502-16	2020-12-23	Llorens- Tusnel 502
54859-502-06	2020-01-31	Llorens- Tusnel 502
54859-502-10	2020-01-31	Llorens- Tusnel 502
54859-502-16	2020-01-31	Llorens- Tusnel 502

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54859-502-06	Tusnel	178 mL in 1 BOTTLE	LIQUID	178	8
54859-502-10	Tusnel	3786 mL in 1 BOTTLE	LIQUID	3786	8
54859-502-16	Tusnel	474 mL in 1 BOTTLE	LIQUID	474	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-502-06	ML - Milliliter	54859-502	1a3e6885-b290-4924-968d-0bd5b2205396	1	2012-07-24
54859-502-10	ML - Milliliter	54859-502	cf383663-23a8-43cf-b04e-772d0bb6464d	1	2012-07-24
54859-502-16	ML - Milliliter	54859-502	1a857136-cb52-4a17-ac69-b737432499fd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
Guaifenesin	ACTIVE MOIETY	495W7451VQ	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54859-502	TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	7	Current NDC, Legacy NDC, 3 package rows	20241225_805dc611-355a-4af5-bf19-464c3290c5c6.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 94 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maximum Strength Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Wal-Mart Stores,Inc.,	a748d5ab-901c-47bb-8437-997542ecebfe	2025-10-28	Warnings	Exact identifier application number: M012
Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom Relief	CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	WAL-MART STORES,INC.	68a68574-0fcb-4569-be57-d9aee5f62bea	2025-10-28	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	635009a1-6154-4c62-a4be-d4f32c2cef8d	2025-10-28	Warnings	Exact identifier application number: M012
Publix Maximum Strength	OXYMETAZOLINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	cf49a06d-f095-48bf-bcd2-a410066ff9af	2025-10-28	Warnings	Exact identifier application number: M012
Publix	OXYMETAZOLINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	283e42b9-173c-4deb-9377-ff649efc177f	2025-10-28	Warnings	Exact identifier application number: M012
Publix Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	eae83b75-9d5a-4100-9304-629e54ef7752	2025-10-28	Warnings	Exact identifier application number: M012
Publix	PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	f10e120d-f0b7-4c51-b29b-e8cdbb1456f3	2025-10-28	Warnings	Exact identifier application number: M012
Family Care Nasal Relief	OXYMETAZOLINE HYDROCHLORIDE	United Exchange Corp	6d0f8e9e-0503-522b-e053-2a91aa0aca35	2025-10-28	Warnings	Exact identifier application number: M012
Family Care Nasal Relief	OXYMETAZOLINE HYDROCHLORIDE	United Exchange Corp	6d0eef2f-f546-d769-e053-2991aa0a8fe4	2025-10-28	Warnings	Exact identifier application number: M012
Sinus Plus Headache	ACETAMINOPHEN, PHENYLEPHRINE HCL	Kroger Company	b622b6cb-f756-439e-8684-d45ee1ea75ab	2025-10-28	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest Congestion Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	P & L Development, LLC	4af67ba7-8892-442c-b9fb-80aba9140e05	2025-10-28	Warnings	Exact identifier application number: M012
No Drip Nasal Mist Nasal Decongestant Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	994fa270-65bb-4097-b88a-d5ce3c0e1c79	2025-10-27	Warnings	Exact identifier application number: M012
Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	WAL-MART STORES INC.	3652ee94-b762-4100-a305-5acbec5f795a	2025-10-27	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief Cold,Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL	Wal-Mart Stores,Inc.,	2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc	2025-10-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	4517c7ef-156c-42b8-a2da-165e936f0837	2025-10-27	Warnings	Exact identifier application number: M012
Allergies MY CHILD NEEDS HELP WITH	DIPHENHYDRAMINE HCL	Unconditional Love	5ad293e9-0a4b-4923-8a91-f01450726828	2025-10-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Cardinal Health 110, LLC. DBA Leader	933a54d3-196d-4c5d-b26f-d18b2d2ba1df	2025-10-27	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	2025-10-27	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Amazon.com Services LLC	4a9fd615-b7d3-452c-ac40-d9189124faaa	2025-10-24	Warnings	Exact identifier application number: M012
allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer Distribution Inc	622b12fa-455c-4432-a9a2-698a929bbd68	2025-10-24	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1098227	dextromethorphan HBr 15 MG / guaiFENesin 200 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	805dc611-355a-4af5-bf19-464c3290c5c6	8
1098227	dextromethorphan hydrobromide 3 MG/ML / guaifenesin 40 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	805dc611-355a-4af5-bf19-464c3290c5c6	8
1098227	dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral Solution	SY	805dc611-355a-4af5-bf19-464c3290c5c6	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54859-502-06	54859050206	178 mL in 1 BOTTLE (54859-502-06)	178 ml	2006-01-01	0000-00-00	No	No	Current
54859-502-10	54859050210	3786 mL in 1 BOTTLE (54859-502-10)	3786 ml	2006-01-01	0000-00-00	No	No	Current
54859-502-16	54859050216	474 mL in 1 BOTTLE (54859-502-16)	474 ml	2006-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Llorens- Tusnel 502	Llorens Pharmaceutical International Division	2025-12-31	HUMAN OTC DRUG LABEL	8