Adult Cough and Chest Congestion Relief DM

Product NDC: 21130-385
11-digit product format: 211300385
Labeler code: 21130
Product ID: 21130-385_2409db7e-fb17-4b06-b55a-3f3036dd0f54
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: Safeway, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-06-30
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: Adult Cough and Chest Congestion Relief DM
Brand name suffix: Non Drowsy
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
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
5bd508a0-2f75-413e-a690-bed970131bef	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21130-385-04	Adult Cough and Chest Congestion Relief DMNon Drowsy	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118	13
21130-385-04	Adult Cough and Chest Congestion Relief DMNon Drowsy	1 in 1 BOX	LIQUID	1	13
21130-385-08	Adult Cough and Chest Congestion Relief DMNon Drowsy	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237	13
21130-385-08	Adult Cough and Chest Congestion Relief DMNon Drowsy	1 in 1 BOX	LIQUID	1	13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3
GLUCOSE OXIDASE	INACTIVE INGREDIENT	0T8392U5N1	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3
MENTHOL, UNSPECIFIED FORM	INACTIVE INGREDIENT	L7T10EIP3A	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-385	ADULT COUGH AND CHEST CONGESTION RELIEF DM NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SAFEWAY, INC.]	11	Current NDC, Legacy NDC, 4 package rows	20241105_5bd508a0-2f75-413e-a690-bed970131bef.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 20 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	319e84fd-4033-f5eb-e063-6394a90aa2f3	2026-06-27	Warnings	Exact identifier application number: M012
HyVee Cough Drops Menthol	MENTHOL	HY-VEE, INC	47a6f3c3-a6fa-dd61-e063-6394a90a4965	2026-06-26	Warnings	Exact identifier application number: M012
HyVee Cough Drops Cherry	MENTHOL	HY-VEE, INC	47a717e9-56b3-e771-e063-6394a90a5c17	2026-06-26	Warnings	Exact identifier application number: M012
Calmco Allergy Relief	DIPHENHYDRAMINE HCL	CalmCo LLC	5532fd37-cdd6-97ab-e063-6394a90a3c77	2026-06-26	Warnings	Exact identifier application number: M012
Dr Kids Allergy Relief	DIPHENHYDRAMINE HCL	CalmCo LLC	5533e705-b8d5-71cf-e063-6394a90a2010	2026-06-26	Warnings	Exact identifier application number: M012
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	HHH Pharmaceuticals	265f1ce7-160c-4dda-b2e0-b78d68f962bd	2026-06-26	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	ee052b39-1658-4071-b081-5433c87b5e4a	2026-06-25	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	DOLGENCORP, LLC	fae1499a-7029-4208-8436-4d330347b915	2026-06-25	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain Maximum Strength	ACETAMINOPHEN, PHENYLEPHRINE HCL	DOLGENCORP, LLC	4fe8f124-ac80-40b4-8e1d-96709c459a4f	2026-06-25	Warnings	Exact identifier application number: M012
Allergy and Sinus Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	91268cd0-c151-4744-a715-a57af3f3a314	2026-06-25	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea	2026-06-24	Warnings	Exact identifier application number: M012
Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	cb475e7f-aec1-415d-9770-07cce4e02c07	2026-06-24	Warnings	Exact identifier application number: M012
Broncolito Children	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	509f5b72-9894-ef44-e063-6394a90a6d07	2026-06-23	Warnings	Exact identifier application number: M012
Neo-Synephrine Severe	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	54edaff7-d241-dc90-e063-6294a90ac64d	2026-06-23	Warnings	Exact identifier application number: M012
AXIV Sinus Severe Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	4b81abf9-3ea7-e996-e063-6394a90a71e8	2026-06-23	Warnings	Exact identifier application number: M012
AXIV Sinus OVERNIGHT	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	54e03a63-f978-33d4-e063-6394a90a30f2	2026-06-23	Warnings	Exact identifier application number: M012
equaline daytime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	9a199782-5d7e-449b-a86c-969746f0e96f	2026-06-23	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Walgreen Company	542b9861-8055-45f6-8cbf-9fe5cde1c4d9	2026-06-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	3c1953a1-32e9-6c81-e063-6294a90a9fa2	2026-06-22	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	59db2573-7ebb-4cf9-bfe3-428929bb4eeb	2026-06-22	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	5bd508a0-2f75-413e-a690-bed970131bef	13
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	5bd508a0-2f75-413e-a690-bed970131bef	13
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	5bd508a0-2f75-413e-a690-bed970131bef	13
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	5bd508a0-2f75-413e-a690-bed970131bef	13
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	5bd508a0-2f75-413e-a690-bed970131bef	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-385-04	21130038504	1 BOTTLE, PLASTIC in 1 BOX (21130-385-04) / 118 mL in 1 BOTTLE, PLASTIC	2014-06-30	0000-00-00	No	No	Current
21130-385-08	21130038508	1 BOTTLE, PLASTIC in 1 BOX (21130-385-08) / 237 mL in 1 BOTTLE, PLASTIC	2014-06-30	0000-00-00	No	No	Current