Tussin DM

Product NDC: 53943-503
11-digit product format: 539430503
Labeler code: 53943
Product ID: 53943-503_62dd7291-4bbf-4c2f-8cd0-7b5cd174768e
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Dosage form: LIQUID
Route: ORAL
Labeler: Discount Drug Mart
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-11-19
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: 2027-12-31
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	Code	Status	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53943-503-26	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53943-503-26	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53943-503-26	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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: Tussin DM
Listing expiration: 2027-12-31

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
dd31f86b-f59e-459a-8e5f-176828706a4a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53943-503-26	2020-12-31	C162847	48780-1	9d75b9cf-f5b1-f424-e053-dadaa90a57ce	dd31f86b-f59e-459a-8e5f-176828706a4a
53943-503-26	2020-01-31	C162847	48780-1	9d75b9cf-f5b1-f424-e053-dadaa90a57ce	dd31f86b-f59e-459a-8e5f-176828706a4a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53943-503-26	Tussin DM	237 mL in 1 PACKAGE	LIQUID	237		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-503	TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	5	Current NDC, Legacy NDC, 1 package rows	20241222_dd31f86b-f59e-459a-8e5f-176828706a4a.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 83 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Coricidin HBP Maximum Strength Cold and Flu Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	e4f3f906-2252-21d1-e053-2a95a90a85df	2025-12-04	Warnings	Exact identifier application number: M012
Afrin No Drip Pump Mist Bundle Pack	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	16c52c79-baec-87db-e063-6294a90a3b3b	2025-12-04	Warnings	Exact identifier application number: M012
Afrin Original Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	0f5ec576-f788-40aa-9088-0dd672e3cc7c	2025-12-04	Warnings	Exact identifier application number: M012
Adult Long Lasting Cough Relief	DEXTROMETHORPHAN HBR	Shield Pharmaceuticals Corp	432a79a9-c69d-4514-894a-7832e1b745ef	2025-12-04	Warnings	Exact identifier application number: M012
GENCONTUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	69d16d25-b09b-430e-8e01-0962d840dc21	2025-12-04	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	H E B	7c04ab14-af28-4598-90ef-56ac11902c7d	2025-12-04	Warnings	Exact identifier application number: M012
Desgen Pediatric	DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL	Kramer Novis	12425c1b-8bdc-446b-83dd-95e05a4d9b8c	2025-12-04	Warnings	Exact identifier application number: M012
Presgen B	DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	5befa829-32bd-4978-8a0e-1d6513ff37a4	2025-12-03	Warnings	Exact identifier application number: M012
TUSSLIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kramer Novis	987e19a5-032f-44e9-b4c7-8a764d502695	2025-12-03	Warnings	Exact identifier application number: M012
DayTime Relief, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION	Lil' Drug Store Products, Inc.	450e8974-8ff8-4b82-e063-6394a90a9366	2025-12-03	Warnings	Exact identifier application number: M012
Nighttime Relief, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTION	Lil' Drug Store Products, Inc.	4510223f-1c88-2796-e063-6394a90a18ac	2025-12-03	Warnings	Exact identifier application number: M012
Carolina Crud Crusher	DEXTROMETHORPHAN HBR, GUAIFENESIN	Weeks & Leo Co., Inc.	0b606683-7d68-cca5-e063-6394a90a6f58	2025-12-03	Warnings	Exact identifier application number: M012
Capmist DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Capital Pharmaceutical, LLC	63733ac3-859e-4a8e-8717-d852bd303408	2025-12-03	Warnings	Exact identifier application number: M012
ALA-HIST IR	DEXBROMPHENIRAMINE MALEATE	Poly Pharmaceuticals, Inc.	0d203b5c-8b10-428b-8703-17be6b4ce6eb	2025-12-03	Warnings	Exact identifier application number: M012
ALAHIST DM	DEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	fdaa062d-110e-798d-e053-6394a90a755c	2025-12-03	Warnings	Exact identifier application number: M012
Alahist D	PHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	a1b8533a-ef8b-57cc-e053-2995a90a5d9e	2025-12-03	Warnings	Exact identifier application number: M012
Alahist PE	DEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	ada2d582-5813-2029-e053-2a95a90ae567	2025-12-03	Warnings	Exact identifier application number: M012
Benadryl Allergy Extra Strength Liqui-Gels	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	30aca3ab-b091-3939-e063-6294a90a9819	2025-12-03	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	L.N.K. International, Inc.	9f2daffc-1904-4d64-9f84-689c88601e06	2025-12-03	Warnings	Exact identifier application number: M012
Childrens Multi-symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	d291faa9-894e-421c-8115-8a8c2a937172	2025-12-03	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	dd31f86b-f59e-459a-8e5f-176828706a4a	6
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	dd31f86b-f59e-459a-8e5f-176828706a4a	6
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	dd31f86b-f59e-459a-8e5f-176828706a4a	6
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	dd31f86b-f59e-459a-8e5f-176828706a4a	6
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	dd31f86b-f59e-459a-8e5f-176828706a4a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53943-503-26	53943050326	237 mL in 1 PACKAGE (53943-503-26)	237 ml	2014-11-19	0000-00-00	No	No	Current