GUAIFENESIN DM

Product NDC: 0121-1276
11-digit product format: 001211276
Labeler code: 0121
Product ID: 0121-1276_c50b4c5c-6f55-4118-a282-e0b490704e49
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN and DEXTROMETHORPHAN
Dosage form: SYRUP
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1992-07-01
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
7355X3ROTS	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
ff970fff-d1a3-4322-83b4-34e361431a1c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0121-1276-00	GUAIFENESIN DM	10 in 1 TRAY	SYRUP	10	8
0121-1276-00	GUAIFENESIN DM	10 in 1 CASE	SYRUP	10	8
0121-1276-10	GUAIFENESIN DM	10 mL in 1 CUP, UNIT-DOSE	SYRUP	10	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1276-00	ML - Milliliter	0121-1276	85c39fa4-6419-4dec-9bae-36a45d499bda	1	2017-12-14
0121-1276-10	ML - Milliliter	0121-1276	e5a70701-5b1c-4cbb-b037-f9dcd4d92c68	1	2017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN	ACTIVE INGREDIENT	7355X3ROTS	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-1276	GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PAI HOLDINGS, LLC DBA PAI PHARMA]	8	Current NDC, Legacy NDC, 3 package rows	20241113_ff970fff-d1a3-4322-83b4-34e361431a1c.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 47 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	c5cb09d4-c049-461c-8898-2c5bb6a8a138	2026-03-04	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	WinCo Foods, LLC	3d96d6d0-8c04-43bb-aed0-4cd00cdf3456	2026-03-04	Warnings	Exact identifier application number: M012
DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	e2994c0f-add8-4f75-a6d2-24cd2af271e4	2026-03-03	Warnings	Exact identifier application number: M012
NIGHTTIME CHERRY COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	36924420-f514-4225-e063-6294a90a330c	2026-03-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS HEALTH CORP	4584d701-5a4e-e54e-e063-6394a90a38d6	2026-03-03	Warnings	Exact identifier application number: M012
foster and thrive nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Sportpharm LLC	7bdfd2ef-bb99-41f5-97ae-3a02c994bddd	2026-03-03	Warnings	Exact identifier application number: M012
Medique at Home Decorel Forte	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	d27b5976-8cc0-4d99-96f6-9069b786affd	2026-03-03	Warnings	Exact identifier application number: M012
Tusnel EX	GUAIFENESIN	A-S Medication Solutions	7f703c9c-2256-4524-9d31-c51919399d26	2026-03-03	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HBR	Best Choice (Valu Merchandisers Company)	f49f1e9a-07ac-443e-9df8-3281d5f35e78	2026-03-03	Warnings	Exact identifier application number: M012
berkley and jensen nasal	OXYMETAZOLINE HYDROCHLORIDE	BJWC	77cbe75d-4ed9-4a8b-91dc-1cc28af25508	2026-03-02	Warnings	Exact identifier application number: M012
childrens cold and cough relief dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Walgreen Company	6c7c950d-ed48-4428-9e9e-73684cabc699	2026-02-28	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Kroger Co.	116146db-719f-4c48-8a8a-1120ea62b0d5	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	1f737b76-14b5-618a-e063-6294a90a19c2	2026-02-27	Warnings	Exact identifier application number: M012
WALGREENS NIGHTTIME ALLERGY RELIEF	DOXYLAMINE SUCCINATE	WALGREENS CO.	a3c7df98-4611-4b61-9c03-5e687364bf74	2026-02-27	Warnings	Exact identifier application number: M012
MEIJER Childrens Allergy Relief Chews	DIPHENHYDRAMINE HCL	MEIJER DISTRIBUTION INC	3368e081-a3b2-4c03-8bd1-05cc6af0391d	2026-02-27	Warnings	Exact identifier application number: M012
CVS PHARMACY Nighttime MS Flu Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR	CVS PHARMACY	23cafaa1-34fe-4cef-960b-5f664ea32cb4	2026-02-27	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest	DEXTROMETHORPHAN HBR, GUAIFENESIN	WinCo Foods, LLC	402969c9-945c-44b7-b018-b62f427ce571	2026-02-26	Warnings	Exact identifier application number: M012
nasal original	OXYMETAZOLINE HYDROCHLORIDE	HyVee Inc	d997f264-1b4a-4cca-a282-bd9645d55bfd	2026-02-26	Warnings	Exact identifier application number: M012
Multi-Symptom Cold and Fever Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	2a569e47-3f17-4fc7-83d6-a3dddfd4987e	2026-02-25	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DN, Cough DM Daytime, Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	184059b7-9238-480e-be4a-ed105f13c19d	2026-02-25	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	ff970fff-d1a3-4322-83b4-34e361431a1c	8
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	ff970fff-d1a3-4322-83b4-34e361431a1c	8
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	ff970fff-d1a3-4322-83b4-34e361431a1c	8
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	ff970fff-d1a3-4322-83b4-34e361431a1c	8
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	ff970fff-d1a3-4322-83b4-34e361431a1c	8
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	c5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed	7
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	c5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed	7
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	c5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed	7
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	c5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed	7
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	c5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-1276-00	00121127600	10 TRAY in 1 CASE (0121-1276-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1276-10)	10 tray	1992-07-01	0000-00-00	No	No	Current
0121-1276-10	00121127610	10 mL in 1 CUP, UNIT-DOSE	10 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GUAIFENESIN DM	Cardinal Health 107, LLC	2026-06-02	HUMAN OTC DRUG LABEL	8
GUAIFENESIN DM	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2024-11-11	HUMAN OTC DRUG LABEL	8
GUAIFENESIN DM	A-S Medication Solutions	2018-06-21	HUMAN OTC DRUG LABEL	9