Tusnel Diabetic

Product NDC: 54859-505
11-digit product format: 548590505
Labeler code: 54859
Product ID: 54859-505_471f18f8-553e-41f9-e063-6394a90ae51e
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan, Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2003-12-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 10; 100 mg/5mL; mg/5mL
Pharmacologic classes: 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]
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	54859-505-16	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54859-505-04	`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	54859-505-16	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54859-505-04	`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 Diabetic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL
GUAIFENESIN	100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
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
996520	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
66b3c094-809e-4d2c-bc15-46563de685cb	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
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
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
54859-505-04	2020-12-23	Llorens-TusnelDiabetic 505
54859-505-16	2020-12-23	Llorens-TusnelDiabetic 505
54859-505-04	2020-01-31	Llorens-TusnelDiabetic 505
54859-505-16	2020-01-31	Llorens-TusnelDiabetic 505

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54859-505-04	Tusnel Diabetic	118 mL in 1 BOTTLE	LIQUID	118		7
54859-505-16	Tusnel Diabetic	472 mL in 1 BOTTLE	LIQUID	472		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-505-04	ML - Milliliter	54859-505	c457a812-04f0-43fe-989e-74cbee67594f	1	2012-07-24
54859-505-16	ML - Milliliter	54859-505	91be4c5f-d3cd-45dd-968d-a2ba0d8922c7	1	2020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54859-505	TUSNEL DIABETIC (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	6	Current NDC, Legacy NDC, 2 package rows	20241225_66b3c094-809e-4d2c-bc15-46563de685cb.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 133 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tenalif Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cd94e7-1808-3bb3-e063-6294a90a4140	2024-12-03	Warnings	Exact identifier application number: M012
Nasal Decongestant PE and Pain Relief Plus Mucus Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Winco Foods, LLC	31531f90-8933-46ab-b722-cb63e7738639	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WINCO FOODS, LLC	f45f3ab4-5e10-3004-e053-2a95a90a0cb4	2024-12-03	Warnings	Exact identifier application number: M012
good sense allergy	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	2861b801-e778-822d-e063-6394a90aa1a8	2024-12-03	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	fe0cf681-f42c-430c-8429-f7ba4bc5a976	2024-12-02	Warnings	Exact identifier application number: M012
Allergy Multisymptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	5a5aa2ee-51b7-4698-bb27-3fb9d01bbea5	2024-12-02	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	0ea270b7-9c28-49fb-9615-c4afdbdbc8f1	2024-12-02	Warnings	Exact identifier application number: M012
Head Congestion Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	0955d856-cc4e-4ef2-8bc0-1a632a5b5f79	2024-12-02	Warnings	Exact identifier application number: M012
Head Congestion Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	40c9c90d-6c9e-40d0-921d-1fd34eff90bb	2024-12-02	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	3d068d30-9a00-49d7-bbe9-d6b53c19e86d	2024-12-02	Warnings	Exact identifier application number: M012
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	76724432-ff3c-404f-ba1f-5af68e3ab8c4	2024-12-02	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	73d4fc82-8508-44f8-83ca-9f32c5cd847b	2024-12-02	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	AAA PHARMACEUTICAL, INC.	19898135-0f7b-45a5-a672-14c49fd21077	2024-12-02	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	bb72de5d-d3c0-42fc-ae52-a3ad95214af5	2024-12-02	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	a242e005-0330-4afb-83b8-13c7d56f5c6d	2024-12-02	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TopCo Associates LLC	53b15e75-9efd-4b4b-834b-6e9f12c60108	2024-12-02	Warnings	Exact identifier application number: M012
Geri-Dryl allergy relief	DIPHENHYDRAMINE HCL	Geri-Care Pharmaceutical Corp	ac8a14ac-7023-1e23-e053-2995a90aea3a	2024-11-28	Warnings	Exact identifier application number: M012
Childrens Benadryl DYE-FREE ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	2024-11-27	Warnings	Exact identifier application number: M012
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	9cd10af6-a2fa-44f8-8df3-a6d2a95a5293	2024-11-27	Warnings	Exact identifier application number: M012
Severe Sinus Congestion Allergy and Cough Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	36a4ec1f-50c3-4d61-ada9-987ccad3563c	2024-11-26	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	66b3c094-809e-4d2c-bc15-46563de685cb	7
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	66b3c094-809e-4d2c-bc15-46563de685cb	7
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	66b3c094-809e-4d2c-bc15-46563de685cb	7
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	66b3c094-809e-4d2c-bc15-46563de685cb	7
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	66b3c094-809e-4d2c-bc15-46563de685cb	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54859-505-04	54859050504	118 mL in 1 BOTTLE (54859-505-04)	118 ml	2003-12-01	0000-00-00	No	No	Current
54859-505-16	54859050516	472 mL in 1 BOTTLE (54859-505-16)	472 ml	2003-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Llorens-TusnelDiabetic 505	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2025-12-29	HUMAN OTC DRUG LABEL	7