Tussin DM Cough and Chest Congestion

Product NDC: 49580-0385
11-digit product format: 495800385
Labeler code: 49580
Product ID: 49580-0385_8228de33-953b-42ee-9bad-286bd3665934
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: P & L Development, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-03-31
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 20; 200 mg/10mL; mg/10mL
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

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 Cough and Chest Congestion
Brand name suffix: Adult
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/10mL
GUAIFENESIN	200 mg/10mL

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
1605844	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
4af67ba7-8892-442c-b9fb-80aba9140e05	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
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49580-0385-2	Tussin DM Cough and Chest CongestionAdult	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118	14
49580-0385-4	Tussin DM Cough and Chest CongestionAdult	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118	14
49580-0385-4	Tussin DM Cough and Chest CongestionAdult	1 in 1 BOX	LIQUID	1	14
49580-0385-8	Tussin DM Cough and Chest CongestionAdult	1 in 1 BOX	LIQUID	1	14
49580-0385-8	Tussin DM Cough and Chest CongestionAdult	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1
MENTHOL, UNSPECIFIED FORM	INACTIVE INGREDIENT	L7T10EIP3A	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49580-0385	TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC]	11	Current NDC, Legacy NDC, 5 package rows	20240127_4af67ba7-8892-442c-b9fb-80aba9140e05.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
1605844	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Suspension	PSN	4af67ba7-8892-442c-b9fb-80aba9140e05	14
1605844	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Suspension	SCD	4af67ba7-8892-442c-b9fb-80aba9140e05	14
1605844	dextromethorphan HBr 20 MG / guaifenesin 200 MG per 10 ML Oral Suspension	SY	4af67ba7-8892-442c-b9fb-80aba9140e05	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49580-0385-2	49580038502	118 mL in 1 BOTTLE, PLASTIC (49580-0385-2)	118 ml	2015-03-31	0000-00-00	No	No	Current
49580-0385-4	49580038504	1 BOTTLE, PLASTIC in 1 BOX (49580-0385-4) / 118 mL in 1 BOTTLE, PLASTIC		2015-03-31	0000-00-00	No	No	Current
49580-0385-8	49580038508	1 BOTTLE, PLASTIC in 1 BOX (49580-0385-8) / 237 mL in 1 BOTTLE, PLASTIC		2015-03-31	0000-00-00	No	No	Current