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 121 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Halls Sugar Free Cherry	MENTHOL	Mondelez Global LLC	ea8dfe96-f6a4-4172-bf9e-ae3cf606ff50	2025-02-14	Warnings	Exact identifier application number: M012
Halls Sugar Free Watermelon	MENTHOL	Mondelez Global LLC	c4c090ca-f083-74e0-e053-2a95a90a9d60	2025-02-14	Warnings	Exact identifier application number: M012
Tukol Max Action	OXYMETAZOLINE HYDROCHLORIDE	Genomma Lab USA	73358103-43dc-4b11-9c89-9a6ba45bf1af	2025-02-14	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Chain Drug Marketing Association Inc.	6c4e867b-24b9-4525-9fab-10f1e7910b13	2025-02-13	Warnings	Exact identifier application number: M012
DAYTIME- NIGHTTIME COLD AND FLU	DAYTIME NIGHTTIME COLD AND FLU	TARGET CORP	9def204a-ee1e-6868-e053-2995a90a76b8	2025-02-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu and Nigttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	f2c11b63-278f-64de-e053-2995a90a5aae	2025-02-12	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	BETTER LIVING BRANDS LLC.	f29c604a-271d-a702-e053-2a95a90a3427	2025-02-12	Warnings	Exact identifier application number: M012
Nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	f2c01090-645c-1efe-e053-2995a90a7df5	2025-02-12	Warnings	Exact identifier application number: M012
AXIV DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	131b1f17-cd86-f9b3-e063-6294a90a3028	2025-02-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Topco Associates, LLC	17d0dbc7-c8c2-7917-e063-6394a90a42af	2025-02-12	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU	DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Kroger Company	bc00bbf8-52bb-fa75-e053-2a95a90a9406	2025-02-11	Warnings	Exact identifier application number: M012
Daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELS	TIME CAP LABORATORIES, INC.	fd24653e-c4fa-3c09-e053-6394a90aaa9e	2025-02-10	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELS	TIME CAP LABORATORIES INC.	fd81dd4b-9617-f4c1-e053-6394a90a5e72	2025-02-10	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	DOLGENCORP, LLC	be2207b7-b8f8-7fba-e053-2a95a90abd16	2025-02-10	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE	Kroger Company	bc0115a3-5322-855d-e053-2995a90aba27	2025-02-10	Warnings	Exact identifier application number: M012
Day time high blood pressure cold and flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR	Camber Consumer Care	09fbd872-0970-4864-9308-4a7b85983920	2025-02-10	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f05e11ce-c908-acbc-e053-2a95a90a584e	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f035c499-cda6-fadf-e053-2995a90af457	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f6d977ce-bbca-f1cc-e053-6394a90acc96	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f6da36d3-496d-2336-e053-6394a90a0f83	2025-02-09	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