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 3 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dollar General	NASAL PHENYLEPHRINE HYDROCHLORIDE	DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)	e8fd3f0e-a023-4423-8906-17ae02bc083b	2026-09-03	Warnings	Exact identifier application number: M012
Mucus Relief Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	TARGET Corporation	1bf9a59e-cc37-4780-ba75-7138c546eb19	2026-09-02	Warnings	Exact identifier application number: M012
Childrens Multi Symptom Fever and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	THE KROGER CO.	3daf7620-eb57-43d5-ba88-938b7221e346	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Gil Pharmaceutical Corp	69fd13a1-2b76-8574-e053-2a91aa0a27e7	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Gil Pharmaceutical Corp.	a6880389-0dc1-43a7-a73b-77f77bafe51e	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Gil Pharmaceutical Corp	fa8510d8-d50a-4743-ba87-a12e9ab43125	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	dfcf1231-8271-458d-b375-e328d6fd4e9b	2026-09-02	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Shield Pharmaceuticals Corp	decafa3a-3734-4161-bab0-121945881846	2026-09-02	Warnings	Exact identifier application number: M012
Kroger Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL	KROGER COMPANY	1ff037ea-1a3b-430a-be31-2e240cc3b6f3	2026-09-02	Warnings	Exact identifier application number: M012
KROGER Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	KROGER COMPANY	79d24014-1af7-4d62-bcb8-5bea76a7d6ee	2026-09-02	Warnings	Exact identifier application number: M012
Kroger No Drip	ALLERGY SINUS	KROGER COMPANY	4788bafb-8866-4a0a-b217-226513799c24	2026-09-02	Warnings	Exact identifier application number: M012
Maximum Strength Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	e1d27123-358f-4b0c-8e3b-33474750a0e6	2026-09-02	Warnings	Exact identifier application number: M012
Maximum Strength Nighttime Cold and Flu	ACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCL	THE KROGER CO	058b2021-8a61-40b0-8a2e-a784d2b847fb	2026-09-02	Warnings	Exact identifier application number: M012
KROGER Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2bea22e9-34b6-4961-94bb-5600dd90e891	2026-09-02	Warnings	Exact identifier application number: M012
KROGER No Drip Nasal Mist Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	KROGER COMPANY	7256e048-ad69-4322-844d-872f05e6fc8a	2026-09-02	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	The Kroger Co.	494e69ef-dc9f-4e14-b856-5eaf0f541a03	2026-09-02	Warnings	Exact identifier application number: M012
MAX Tussin Cough and Chest Congestion DM Sugar Free	DEXTROMETHORPHAN HBR, GUAIFENESIN	Akron Pharma Inc.	5c4c8115-cec9-4f2c-9ea9-328535e97b07	2026-09-01	Warnings	Exact identifier application number: M012
MAX ALLERGY KIDS	DIPHENHYDRAMINE HCL	Akron Pharma Inc.	96c4ade8-67b1-41e5-8624-fb49090208af	2026-09-01	Warnings	Exact identifier application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE	HEXYLRESORCINOL AND MENTHOL	Reckitt Benckiser LLC	4a938e15-a996-8538-e063-6294a90ad4ee	2026-09-01	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	WALMART INC.	5e6623c3-6210-4c50-94d6-5554f36876d1	2026-08-31	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