Tusnel DM

Product NDC: 54859-603
11-digit product format: 548590603
Labeler code: 54859
Product ID: 54859-603_47463023-1b8c-729b-e063-6394a90a8dce
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan, Guiafenesin, Pseudoephedrine HCl
Dosage form: SOLUTION/ DROPS
Route: ORAL
Labeler: Llorens Pharmaceutical International Division
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1993-01-01
Substance: GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 25; 7.5; 2.5 mg/mL; mg/mL; mg/mL
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 · 4 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	54859-603-02	`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	54859-603-02	`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 DM
Brand name suffix: Pediatric
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	25 mg/mL
PSEUDOEPHEDRINE HYDROCHLORIDE	7.5 mg/mL
DEXTROMETHORPHAN HYDROBROMIDE	2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1241674	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
d915eab8-013e-4ce3-b358-0d531e5ca1ba	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
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
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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54859-603-02	2020-12-23	C162847	48780-1	9d75b9d0-98b6-f424-e053-dadaa90a57ce	Llorens-Tusnel DMPedDrops 603
54859-603-02	2020-01-31	C162847	48780-1	9d75b9d0-98b6-f424-e053-dadaa90a57ce	Llorens-Tusnel DMPedDrops 603

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54859-603-02	Tusnel DMPediatric	60 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	60		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-603-02	ML - Milliliter	54859-603	f2d07a6c-f7f3-4c44-9465-b222a0bafdb7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
Guaifenesin	ACTIVE MOIETY	495W7451VQ	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54859-603	TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]	8	Current NDC, Legacy NDC, 1 package rows	20241222_d915eab8-013e-4ce3-b358-0d531e5ca1ba.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 138 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
careone tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	American Sales Company	6c90fccf-0e6f-43df-9468-d8ece8ded009	2024-11-11	Warnings	Exact identifier application number: M012
good sense night time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	89dc1423-d097-47a8-9025-eab5381cca26	2024-11-11	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	10f9627b-edda-422a-b01f-7066f9c98335	2024-11-11	Warnings	Exact identifier application number: M012
nighttime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	17c3fe42-3c40-4405-80b7-b3f9e4aa8376	2024-11-11	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	1dd36aa7-f085-4350-8cf2-f9fa29b583e4	2024-11-11	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	a7f9f1d0-7498-461c-b4e8-4c92cf3feae8	2024-11-11	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	bd079f5d-0a38-40e6-9661-e8236c88a24d	2024-11-11	Warnings	Exact identifier application number: M012
GUAIFENESIN DM	GUAIFENESIN AND DEXTROMETHORPHAN	PAI Holdings, LLC dba PAI Pharma	ff970fff-d1a3-4322-83b4-34e361431a1c	2024-11-11	Warnings	Exact identifier application number: M012
topcare tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	e1118592-30ac-4505-9f38-c6d395c4cf5b	2024-11-11	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	624b8029-9fdb-4908-a13b-f9dd75030120	2024-11-11	Warnings	Exact identifier application number: M012
Biofreeze Colorless	MENTHOL	A-S Medication Solutions	cc1cba14-da40-4d7d-b522-b5c648798e96	2024-11-11	Warnings	Exact identifier application number: M012
foster and thrive nighttime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	298b7754-d0d8-496d-9949-4c346cb11e34	2024-11-11	Warnings	Exact identifier application number: M012
leader tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	b418c10c-528b-4395-944e-af959b639ec2	2024-11-10	Warnings	Exact identifier application number: M012
equaline adult tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	f7c753f8-4b12-4797-a599-736d597bc1bc	2024-11-10	Warnings	Exact identifier application number: M012
foster and thrive adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Strategic Sourcing Services LLC	f8933226-fbc9-44e3-a90f-4e6c1dbdb7b7	2024-11-10	Warnings	Exact identifier application number: M012
dg health adult tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dolgencorp Inc	81f12484-ddf7-49c6-b530-3a81d62ab40d	2024-11-10	Warnings	Exact identifier application number: M012
careone tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Retail Business Services, LLC	230fa1ea-ae7c-425e-8447-79a90c96ae9e	2024-11-10	Warnings	Exact identifier application number: M012
good sense tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	L. Perrigo Company	cb8a1d81-b1a3-4217-b157-9e5d398f202d	2024-11-09	Warnings	Exact identifier application number: M012
PhysiciansCare Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	Acme United Corporation	5e31b1ff-291f-7b8c-e053-2a91aa0aedbc	2024-11-09	Warnings	Exact identifier application number: M012
Duraflu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	55fffc1d-8449-4c28-a391-c6f60dd85622	2024-11-09	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
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1241674	dextromethorphan HBr 2.5 MG / guaiFENesin 25 MG / pseudoephedrine HCl 7.5 MG in 1 mL Oral Solution	PSN	d915eab8-013e-4ce3-b358-0d531e5ca1ba	9
1241674	dextromethorphan hydrobromide 2.5 MG/ML / guaifenesin 25 MG/ML / pseudoephedrine hydrochloride 7.5 MG/ML Oral Solution	SCD	d915eab8-013e-4ce3-b358-0d531e5ca1ba	9
1241674	dextromethorphan hydrobromide 2.5 MG / guaifenesin 25 MG / pseudoephedrine hydrochloride 7.5 MG per 1 ML Oral Solution	SY	d915eab8-013e-4ce3-b358-0d531e5ca1ba	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54859-603-02	54859060302	60 mL in 1 BOTTLE, DROPPER (54859-603-02)	60 ml	1993-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Llorens-Tusnel DMPedDrops 603	Llorens Pharmaceutical International Division	2025-12-31	HUMAN OTC DRUG LABEL	9