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
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
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 22 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive daytime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Strategic Sourcing Services LLC	067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a6	2026-06-16	Warnings	Exact identifier application number: M012
Equate Severe Cold Cough and Flu	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	a35531d7-1a96-45cb-922f-61db085cde1f	2026-06-16	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	5fe9f313-d6e7-41f5-abfc-e4c72b708961	2026-06-15	Warnings	Exact identifier application number: M012
Pain Relief Sinus Congestion	ACETAMINOPHEN, PHENYLEPHRINE HCL	Better Living Brands, LLC	1d3d6397-0d92-4145-9a70-8bcc45bd0322	2026-06-15	Warnings	Exact identifier application number: M012
Goodmeds Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f11	2026-06-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	d5d9334d-3db6-4f45-ab84-3e1ec5a752c6	2026-06-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Geiss, Destin & Dunn Inc.	fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b	2026-06-15	Warnings	Exact identifier application number: M012
equate daytime cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	983a4783-d826-41b6-8087-ca66bcd5b6ca	2026-06-12	Warnings	Exact identifier application number: M012
Equate Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	4173ecde-a2d7-4836-a6e9-fef2270d1b4e	2026-06-12	Warnings	Exact identifier application number: M012
PAIN RELIEVER PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Best Choice (Valu Merchandisers Company)	cf370a59-42d5-42fe-882f-09885c55f570	2026-06-11	Warnings	Exact identifier application number: M012
Sudafed Sinus Congestion Plus Cold Severe Day	ACETAMINOPHEN, PSEUDOEPHEDRINE	Kenvue Brands LLC	537e1a0d-820d-c3f7-e063-6294a90a56ea	2026-06-10	Warnings	Exact identifier application number: M012
Sudafed Sinus Congestion plus Cold Severe Day and Night	ACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINE	Kenvue Brands LLC	5382dcad-0337-4440-e063-6394a90a706e	2026-06-10	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	21cfa71c-7a8f-4100-a42e-9190260653d1	2026-06-09	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL	WALGREENS	47f1d92f-cb4b-1635-e063-6294a90a2c71	2026-06-09	Warnings	Exact identifier application number: M012
HALLS Honey	MENTHOL	Mondelez Global LLC	837f5ded-8efb-402b-a1bc-b5c142755660	2026-06-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution Inc	932b11b1-f4a0-417a-bfa1-05261a172155	2026-06-08	Warnings	Exact identifier application number: M012
NO DRIP NASAL MIST	OXYMETAZOLINE HYDROCHLORIDE	Kroger Company	957efbcf-b6d3-4793-bb6e-27e99c9be905	2026-06-08	Warnings	Exact identifier application number: M012
DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	493caecb-e687-49ea-b7a1-2a5b9376896d	2026-06-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	4ad10fd7-c088-4356-9d34-a95cfe3a4133	2026-06-08	Warnings	Exact identifier application number: M012
Theraflu Severe Congestion Relief Nasal Mist	OXYMETAZOLINE HCL	Haleon US Holdings LLC	4ec42064-7390-4137-a93e-57343c3c76a7	2026-06-08	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