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 101 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Dextrum Laboratories, Inc	3f79137f-f0b0-d22c-e063-6394a90a7245	2025-09-23	Warnings	Exact identifier application number: M012
GoodSense Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	GOOD SENSE	240bb6af-9d38-49fe-9011-3016246b0986	2025-09-23	Warnings	Exact identifier application number: M012
Xpect Honey Lemon Cough Drops	HONEY LEMON COUGH DROPS	Cintas Corporation	79e0b7c1-4acc-41d2-89cd-d075a8bac0c9	2025-09-23	Warnings	Exact identifier application number: M012
Topcare NiteTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	b2b3c450-e988-41d1-9e53-cc8e30d75cb4	2025-09-23	Warnings	Exact identifier application number: M012
Xpect Cherry Cough Drops	CHERRY COUGH DROPS	Cintas Corporation	d1fd2f23-5435-405d-a7fd-644691f79e80	2025-09-23	Warnings	Exact identifier application number: M012
Topcare DayTime NiteTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	560fb22b-391f-4d7b-a6fd-38d577d404b0	2025-09-23	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GUAIFENESIN	Dextrum Laboratories Inc.	3f67ac3d-1503-3418-e063-6394a90a938f	2025-09-22	Warnings	Exact identifier application number: M012
Giltuss HBP Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories Inc.	3f68e68a-cf32-9df8-e063-6394a90a3012	2025-09-22	Warnings	Exact identifier application number: M012
SUPRESS A	DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kramer Novis	f0bec5f5-4d76-471e-9024-557eba848b93	2025-09-22	Warnings	Exact identifier application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	9f050fb0-6100-4b14-b82f-1d5fcbf16540	2025-09-22	Warnings	Exact identifier application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	c6392ace-c7d1-4450-8b71-4dccc60b4f02	2025-09-22	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3f12ee8f-d1c6-d73a-e063-6394a90a9199	2025-09-18	Warnings	Exact identifier application number: M012
CVS Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy	3d71d306-893a-e73a-e063-6394a90a0a3b	2025-09-18	Warnings	Exact identifier application number: M012
Giltuss D	GILTUSS D	Dextrum Laboratories Inc.	3f17eefb-b625-b0f2-e063-6294a90afd4d	2025-09-18	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Major Pharmaceuticals	6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b	2025-09-17	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Dextrum Laboratories Inc	3effaf4b-28c3-6131-e063-6294a90a17ff	2025-09-17	Warnings	Exact identifier application number: M012
AXIV DayTime - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	1872e1ff-2e08-c404-e063-6294a90afa14	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	1323a67c-b9c5-038c-e063-6394a90a5e6b	2025-09-17	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3f025ef6-79e7-e833-e063-6294a90ab501	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Night Time - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	186f8519-655d-bd21-e063-6294a90a16a8	2025-09-17	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