Tussin DM

Product NDC: 69842-699
11-digit product format: 698420699
Labeler code: 69842
Product ID: 69842-699_faf0eaea-ff1c-411f-b7ad-f0362d7d9b32
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Doxylamine succinate
Dosage form: SOLUTION
Route: ORAL
Labeler: CVS Pharmacy
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-06-25
Substance: DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 30; 12.5 mg/20mL; mg/20mL
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/20mL
DOXYLAMINE SUCCINATE	12.5 mg/20mL

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
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115329	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
fc1e224c-5c57-43fc-ae6e-36aa0a4ae439	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
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
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
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69842-699-26	Tussin DM	1 in 1 CARTON	SOLUTION	1		5
69842-699-26	Tussin DM	118 mL in 1 BOTTLE	SOLUTION	118		5
69842-699-26	tussin dm max daytime nighttime	1 in 1 CARTON	SOLUTION		30 mg in 20mL	4
69842-699-26	tussin dm max daytime nighttime	118 mL in 1 BOTTLE	SOLUTION	118 mL	12.5 mg in 20mL	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-699	TUSSIN DM (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]	4	Current NDC, Legacy NDC, 2 package rows	20241120_fc1e224c-5c57-43fc-ae6e-36aa0a4ae439.zip
69842-699	TUSSIN DM MAX DAYTIME NIGHTTIME (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN) KIT [CVS PHARMACY]	4	Current NDC, Legacy NDC	20241218_6feaf29e-de06-4c94-912c-a76ea2cbd8c1.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 96 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TexaClear Pain and Chest Congestion Relief	CHOLINE SALICYLATE,GUAIFENESIN	GM Pharmaceuticals, INC	672bc78a-2c71-4135-b64a-2b8c40ac688c	2025-10-13	Warnings	Exact identifier application number: M012
Vapor Stick	CAMPHOR/MENTHOL	Rejoice International Corp.	33d1fbf3-d33c-58b9-e063-6294a90ae098	2025-10-13	Warnings	Exact identifier application number: M012
Nitetime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	47f03174-6e91-4529-bbfa-ce58aa7b7d79	2025-10-13	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	db81e32b-0cad-400b-8479-a3b51de92b12	2025-10-10	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	852b77ae-a5ac-3ead-e053-2a91aa0a54bd	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	8503c956-42a5-7684-e053-2991aa0adb27	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss HBP Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	852ceea2-d6a1-6de2-e053-2a91aa0ad50d	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	852d5f01-9289-5515-e053-2a91aa0acf32	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Diabetic Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	85183b38-ce2a-0e0e-e053-2991aa0a336f	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss MultiSymptom Cold and Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Giltuss Pharmaceutical Corp	8518fd91-981e-de78-e053-2a91aa0afcb2	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens MultiSymptom Cold and Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Giltuss Pharmaceutical Corp	852c8cd6-271f-0fa8-e053-2991aa0ab179	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Allergy Plus Cough and Congestion	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	85065cf3-386d-22d5-e053-2a91aa0a72da	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Gil Pharmaceutical Corp	a8b2c847-25e9-8714-e053-2995a90a73ce	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens Allergy Plus Cough and Congestion	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	852c5a57-7ee4-3c5c-e053-2a91aa0a1433	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	a8c5027f-9701-fb07-e053-2a95a90a6029	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Gil Pharmaceutical Corp	a8c052d8-fb9f-09f2-e053-2a95a90a37af	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GUAIFENESIN	Gil Pharmaceutical Corp	a8c53c14-ba82-2c68-e053-2a95a90a9894	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Severe Sinus	OXYMETAZOLINE HCL	Gil Pharmaceutical Corp	ab7fae3b-1f7d-5d0f-e053-2a95a90a148e	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	a8c08532-1169-6603-e053-2a95a90a3484	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss EX Expectorant	GUAIFENESIN	Gil Pharmaceutical Corp	a8c59e6d-c11c-2664-e053-2a95a90a8333	2025-10-09	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
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1115329	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution	PSN	fc1e224c-5c57-43fc-ae6e-36aa0a4ae439	5
1115329	dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution	SCD	fc1e224c-5c57-43fc-ae6e-36aa0a4ae439	5
1115329	dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution	SY	fc1e224c-5c57-43fc-ae6e-36aa0a4ae439	5
1115329	dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution	SY	fc1e224c-5c57-43fc-ae6e-36aa0a4ae439	5
2056073	{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } Pack	GPCK	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	4
2056073	1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution) Pack	PSN	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	4
1020138	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution	PSN	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	4
1115329	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution	PSN	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	4
1020138	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	4
1115329	dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution	SCD	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	4
2056073	1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution) Pack	SY	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	4
1020138	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution	SY	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	4
1020138	dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	4
1115329	dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution	SY	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	4
1115329	dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution	SY	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-699-26	69842069926	1 BOTTLE in 1 CARTON (69842-699-26) / 118 mL in 1 BOTTLE	1 bottle	2018-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Pharmacy, Inc. Tussin DM Drug Facts	CVS Pharmacy	2025-08-06	HUMAN OTC DRUG LABEL	5
CVS Pharmacy, Inc. Tussin DM Drug Facts	CVS Pharmacy	2024-12-16	HUMAN OTC DRUG LABEL	4