Tusnel

Product NDC: 54859-544
11-digit product format: 548590544
Labeler code: 54859
Product ID: 54859-544_47461ad3-a121-2a11-e063-6294a90a0f8f
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: 5; 50; 15 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 · 6 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	54859-544-04	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54859-544-16	`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	54859-544-04	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54859-544-16	`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
Brand name suffix: Pediatric
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/5mL
GUAIFENESIN	50 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE	15 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
1098911	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
82f447f6-4f1b-4f56-9d7d-ea02adeea88c	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
54859-544-04	2020-12-23	Llorens-Tusnel Ped 544
54859-544-16	2020-12-23	Llorens-Tusnel Ped 544
54859-544-04	2020-01-31	Llorens-Tusnel Ped 544
54859-544-16	2020-01-31	Llorens-Tusnel Ped 544

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54859-544-04	TusnelPediatric	118 mL in 1 BOTTLE	LIQUID	118		9
54859-544-16	TusnelPediatric	473 mL in 1 BOTTLE	LIQUID	473		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-544-04	ML - Milliliter	54859-544	d7f3d47e-5961-483e-b7c9-04be86cf7999	1	2012-07-24
54859-544-16	ML - Milliliter	54859-544	1c52ee16-f421-4855-926f-e9a37cd6ed41	1	2025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
Guaifenesin	ACTIVE MOIETY	495W7451VQ	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
CORN SYRUP	INACTIVE INGREDIENT	9G5L16BK6N	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54859-544	TUSNEL PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	8	Current NDC, Legacy NDC, 2 package rows	20241222_82f447f6-4f1b-4f56-9d7d-ea02adeea88c.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 37 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	50762d7c-5efd-4f83-e063-6294a90abf7f	2026-04-27	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	6427b418-89d1-4eac-b25b-0adfefc204fc	2026-04-27	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Care One (American Sales Company)	bd5de3b3-7cb5-4403-b664-23ac70b9957f	2026-04-27	Warnings	Exact identifier application number: M012
Leader Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	333c7042-95b8-4d98-9df1-4287017afa36	2026-04-25	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Sportpharm LLC	f2d55d1b-c3d4-4c35-b761-681ed50273bd	2026-04-24	Warnings	Exact identifier application number: M012
Geri-Dryl allergy relief	DIPHENHYDRAMINE HCL	Sportpharm LLC	2c4e0d5e-958d-4274-876a-52126c795c0f	2026-04-24	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	50364a42-3333-51fe-e063-6394a90ab71e	2026-04-24	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5036dc50-e95b-ea8d-e063-6394a90a6cfe	2026-04-24	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	dcb33d5f-87fa-4043-9b6d-36adec96796c	2026-04-24	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	Cardinal Health 107, LLC	abc0e348-8532-4658-bd8c-d7dbe5a28c7d	2026-04-23	Warnings	Exact identifier application number: M012
nitetime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Publix Super Markets Inc	c5535aaf-c029-48d8-97d1-105a49b5fd95	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer Healthcare LLC.	50228b3c-d54a-485d-e063-6394a90a4403	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Flu Severe Fast Chewables	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5025a333-6378-bf59-e063-6394a90af4f0	2026-04-23	Warnings	Exact identifier application number: M012
POLY-HIST DM	DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR	POLY PHARMACEUTICALS, INC.	5025c99f-b946-e2e0-e063-6394a90a13fb	2026-04-23	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5026611c-93e7-8f90-e063-6394a90a7baa	2026-04-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	c9c1db0f-6ba4-433c-b0ce-e99e9351c0b0	2026-04-23	Warnings	Exact identifier application number: M012
Severe Cold and Flu Plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	COSTCO WHOLESALE CORPORATION	5180abbc-c6c4-4b82-b6e7-4504e3bcff0f	2026-04-23	Warnings	Exact identifier application number: M012
Severe Cold and Flu Night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	HyVee Inc	4f963491-e1f0-494d-acb6-5f4d2b267d4a	2026-04-22	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	f4b01827-7444-3bfc-e053-2a95a90aebed	2026-04-22	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH,	cfd43b8f-8064-6b88-e053-2a95a90a329e	2026-04-22	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
1098911	dextromethorphan HBr 5 MG / guaiFENesin 50 MG / pseudoephedrine HCl 15 MG in 5 mL Oral Solution	PSN	82f447f6-4f1b-4f56-9d7d-ea02adeea88c	9
1098911	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution	SCD	82f447f6-4f1b-4f56-9d7d-ea02adeea88c	9
1098911	dextromethorphan HBr 5 MG / guaifenesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral Solution	SY	82f447f6-4f1b-4f56-9d7d-ea02adeea88c	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54859-544-04	54859054404	118 mL in 1 BOTTLE (54859-544-04)	118 ml	2006-01-01	0000-00-00	No	No	Current
54859-544-16	54859054416	473 mL in 1 BOTTLE (54859-544-16)	473 ml	2006-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Llorens-Tusnel Ped 544	Llorens Pharmaceutical International Division	2025-12-31	HUMAN OTC DRUG LABEL	9