Guaifenesin DM

Product NDC: 60687-828
11-digit product format: 606870828
Labeler code: 60687
Product ID: 60687-828_1d74f48d-1aa4-b779-e063-6394a90af176
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Dextromethorphan
Dosage form: SYRUP
Route: ORAL
Labeler: American Health Packaging
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-08-04
Substance: GUAIFENESIN; DEXTROMETHORPHAN
Active strength: 200; 20 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: 2026-12-31
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: Guaifenesin DM
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup
7355X3ROTS	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
8632a655-7f5b-450f-95fa-62478a174e9c	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
60687-828-42	Guaifenesin DM	10 mL in 1 CUP, UNIT-DOSE	SYRUP	10	1
60687-828-48	Guaifenesin DM	10 in 1 TRAY	SYRUP	10	1
60687-828-56	Guaifenesin DM	10 in 1 CASE	SYRUP	10	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-828-42	ML - Milliliter	60687-828	6d4e5ec6-2f1e-454e-b08f-9e0c798fe8e0	1	2024-08-12
60687-828-56	ML - Milliliter	60687-828	d2313ab3-6e3c-49be-b3e5-8e3d61f4dcdc	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-828	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [AMERICAN HEALTH PACKAGING]	1	Current NDC, 3 package rows	20240807_8632a655-7f5b-450f-95fa-62478a174e9c.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 28 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	7354f57c-0ecf-481f-9482-0040c90c4350	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	5bda415d-739f-4ca5-b5b2-07c14a81863b	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8f3eb5c5-832e-4806-b3da-ef112cf55dcf	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE	Reckitt Benckiser LLC	e3aea6df-37a4-43c5-a192-a902cbff3f92	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9e5a8d7-814c-4ab1-bb05-e4cb9155978e	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack	ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	Reckitt Benckiser LLC	c7ab5201-8550-4bf4-957c-c8f049aeaa4a	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	84e7be8f-2785-45ef-9c44-de05394fcd99	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	771d7fd8-184f-48a3-90ed-e8f00159d97e	2026-05-18	Warnings	Exact identifier application number: M012
MUCINEX Childrens Stuffy Nose	OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	de1c0abd-1644-4351-8106-e9df6ca5c142	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Fever Sore Throat and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	1538a75d-582a-9501-e063-6394a90a6c55	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	19105007-0193-0764-e063-6294a90a01a4	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and Flu	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	34fd2458-9acd-cdf7-e063-6394a90a3d0a	2026-05-18	Warnings	Exact identifier application number: M012
MUCINEX FAST-MAX NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3a24b06c-00a6-c2ef-e063-6294a90a4d72	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	14be3ab0-d6ae-e342-e063-6294a90ab851	2026-05-18	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Bryant Ranch Prepack	20f00537-2c8a-45d1-8e5f-ec276d0a47b6	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	38df2308-f6f9-4476-ad34-4b5bc5f9fdf2	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Plus Headache Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	88e3b969-79d0-4e64-95c0-c5cfd41e365f	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	db264d2f-bf81-4da2-8595-2bfa1e4ba2f1	2026-05-18	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c	2026-05-15	Warnings	Exact identifier application number: M012
good neighbor pharmacy cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	da91e6b6-32ff-44fd-afce-33ea9549554b	2026-05-15	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
7355X3ROTS	DEXTROMETHORPHAN	125-71-3	DEXTROMETHORPHAN

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	8632a655-7f5b-450f-95fa-62478a174e9c	1
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	8632a655-7f5b-450f-95fa-62478a174e9c	1
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	8632a655-7f5b-450f-95fa-62478a174e9c	1
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	8632a655-7f5b-450f-95fa-62478a174e9c	1
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	8632a655-7f5b-450f-95fa-62478a174e9c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60687-828-42	60687082842	10 mL in 1 CUP, UNIT-DOSE	10 ml				Historical
60687-828-48	60687082848	10 in 1 TRAY					Historical
60687-828-56	60687082856	10 TRAY in 1 CASE (60687-828-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-828-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-828-42)	10 tray	2024-08-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GUAIFENESIN and DEXTROMETHORPHAN SYRUP Drug Facts	American Health Packaging	2024-08-04	HUMAN OTC DRUG LABEL	1