GUAIFENESIN

Product NDC: 0121-1744
11-digit product format: 001211744
Labeler code: 0121
Product ID: 0121-1744_25a970c7-0016-4f22-9e94-1e20e1319e3e
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2002-09-01
Substance: GUAIFENESIN
Active strength: 100 mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
310604	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
c2e53fb5-2798-47c8-9285-d1077d46e629	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
0121-1744-00	GUAIFENESIN	10 in 1 CASE	SOLUTION	10	9
0121-1744-00	GUAIFENESIN	10 in 1 TRAY	SOLUTION	10	9
0121-1744-05	GUAIFENESIN	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1744-00	ML - Milliliter	0121-1744	171bdc6a-7b5f-45a7-87e1-b202b3ef5ad4	1	2018-01-12
0121-1744-05	ML - Milliliter	0121-1744	80ee20cf-4e2b-4882-bcd2-cbd2ec3f4671	1	2014-10-03
0121-1744-10	ML - Milliliter	0121-1744	29730dba-fb62-49e5-b8f8-98345a3002ea	1	2014-10-03
0121-1744-15	ML - Milliliter	0121-1744	8868bbf3-ee16-4fa4-8362-f51827a901a0	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	GUAIFENESIN LIQUID [CARDINAL HEALTH]	3
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN LIQUID [CARDINAL HEALTH]	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	GUAIFENESIN LIQUID [CARDINAL HEALTH]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	GUAIFENESIN LIQUID [CARDINAL HEALTH]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	GUAIFENESIN LIQUID [CARDINAL HEALTH]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GUAIFENESIN LIQUID [CARDINAL HEALTH]	3
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	GUAIFENESIN LIQUID [CARDINAL HEALTH]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	GUAIFENESIN LIQUID [CARDINAL HEALTH]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	GUAIFENESIN LIQUID [CARDINAL HEALTH]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	GUAIFENESIN LIQUID [CARDINAL HEALTH]	3
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-1744	GUAIFENESIN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	9	Current NDC, Legacy NDC, 3 package rows	20241113_c2e53fb5-2798-47c8-9285-d1077d46e629.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 38 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	0b34b5a3-98a2-4096-9d95-071bb5a63c86	2026-04-17	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN	Walgreen Company	1cd69ede-29c6-4216-95b7-b58fc96c084b	2026-04-16	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Valu Merchandisers Company	cdcb8e0d-7847-4f28-bb09-7dc7b5d35c13	2026-04-16	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Valu Merchandisers Company	b0d9d869-9f0d-4834-aa2b-1ee21fd8b67b	2026-04-16	Warnings	Exact identifier application number: M012
Rompe Pecho Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN	Efficient Laboratories Inc	4f86985c-48f3-2148-e063-6394a90ae2f1	2026-04-15	Warnings	Exact identifier application number: M012
Childrens Daytime Mucus	DEXTROMETHORPHAN HBR	Walgreens	7a55b7e1-1054-421e-847e-5e4d90d1aebb	2026-04-15	Warnings	Exact identifier application number: M012
Childrens Nighttime Mucus	DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	Walgreens	dc69f581-27c7-4030-bb18-39685c7691a1	2026-04-15	Warnings	Exact identifier application number: M012
Pseudoephedrine HCl	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	da95c643-7122-4025-977f-42205080e56b	2026-04-15	Warnings	Exact identifier application number: M012
Daytime Nighttime Chewable	DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	Walgreens	9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c6	2026-04-15	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4f7090f4-89c9-c3da-e063-6294a90a4716	2026-04-14	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN, PHENYLEPHRINE HCL	Walgreen Company	2115f095-2d75-4e02-a6af-22dd693e0840	2026-04-14	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Lidl US LLC	00f89eee-0edc-40dc-9297-8645afb91004	2026-04-14	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	8647c136-a323-453a-8f57-e66938bbf639	2026-04-14	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	5515148f-3e1d-4b03-89fa-40967d508292	2026-04-14	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	c70e6506-6c5b-4d3f-ab18-a690840caabc	2026-04-13	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	Walgreen Company	48387b95-8240-4d6e-842b-cc29cc18709c	2026-04-13	Warnings	Exact identifier application number: M012
Sinufrin Plus No Drip Decongestant	NASAL CONGESTION RELIEF	NeilMed Pharmaceuticals Inc	4f06c732-1f9f-bfc6-e063-6394a90a53f5	2026-04-13	Warnings	Exact identifier application number: M012
Severe Sinus Congestion	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	8745d9d8-640d-4e3b-96fe-d25032c1e3ce	2026-04-13	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	5a5c5f33-5b70-465d-a38b-6f518af09788	2026-04-13	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	Publix Super Markets Inc	f2263e38-f686-45ed-bf85-b47f5e1aa982	2026-04-13	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	888b6a2e-6631-4585-a7fe-eb122eb51b23	10
310604	guaifenesin 20 MG/ML Oral Solution	SCD	888b6a2e-6631-4585-a7fe-eb122eb51b23	10
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	888b6a2e-6631-4585-a7fe-eb122eb51b23	10
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	888b6a2e-6631-4585-a7fe-eb122eb51b23	10
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	888b6a2e-6631-4585-a7fe-eb122eb51b23	10
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	888b6a2e-6631-4585-a7fe-eb122eb51b23	10
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	888b6a2e-6631-4585-a7fe-eb122eb51b23	10
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	c2e53fb5-2798-47c8-9285-d1077d46e629	9
310604	guaifenesin 20 MG/ML Oral Solution	SCD	c2e53fb5-2798-47c8-9285-d1077d46e629	9
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	c2e53fb5-2798-47c8-9285-d1077d46e629	9
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	c2e53fb5-2798-47c8-9285-d1077d46e629	9
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	c2e53fb5-2798-47c8-9285-d1077d46e629	9
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	c2e53fb5-2798-47c8-9285-d1077d46e629	9
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	c2e53fb5-2798-47c8-9285-d1077d46e629	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-1744-00	00121174400	10 TRAY in 1 CASE (0121-1744-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1744-05)	10 tray	2002-09-01	0000-00-00	No	No	Current
0121-1744-05	00121174405	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
0121-1744-10	00121174410	10 TRAY in 1 CASE (0121-1744-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE	10 tray	2002-09-01	0000-00-00	No	No	Current
0121-1744-15	00121174415	10 TRAY in 1 CASE (0121-1744-15) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE	10 tray	2002-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GUAIFENESIN	Cardinal Health 107, LLC	2026-06-18	HUMAN OTC DRUG LABEL	11
GUAIFENESIN	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2022-06-14	HUMAN OTC DRUG LABEL	9
GUAIFENESIN	Cardinal Health	2018-01-15	HUMAN OTC DRUG LABEL	4