Guaifenesin

Product NDC: 81033-102
11-digit product format: 810330102
Labeler code: 81033
Product ID: 81033-102_316ac9e6-8d03-f55a-e063-6294a90a8540
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: KESIN PHARMA CORPORATION
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-11-20
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
365c01b7-a197-4876-85fc-42204f787e3a	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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81033-102-05	Guaifenesin	5 mL in 1 CUP, UNIT-DOSE	LIQUID	5	7
81033-102-10	Guaifenesin	10 mL in 1 CUP, UNIT-DOSE	LIQUID	10	7
81033-102-51	Guaifenesin	50 in 1 CARTON	LIQUID	50	7
81033-102-52	Guaifenesin	50 in 1 CARTON	LIQUID	50	7
81033-102-16	Guaifenesin	473 mL in 1 BOTTLE	LIQUID	473	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81033-102-05	ML - Milliliter	81033-102	c04493a2-a5df-4be5-86e1-38cd698bbd63	1	2024-03-12
81033-102-10	ML - Milliliter	81033-102	a990cc84-2678-4699-8dca-ec8808a024a4	1	2024-04-05
81033-102-16	ML - Milliliter	81033-102	7a1f8916-cb71-4e4c-a447-b4f532f27ea3	1	2025-06-13
81033-102-51	ML - Milliliter	81033-102	118824ef-231f-4404-85a9-9e31242703de	1	2024-01-04
81033-102-52	ML - Milliliter	81033-102	0be6c67c-993a-4d6d-9ecc-515e876c5d39	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81033-102	GUAIFENESIN LIQUID [KESIN PHARMA CORPORATION]	7	Current NDC, 4 package rows	20250331_365c01b7-a197-4876-85fc-42204f787e3a.zip
81033-102	GUAIFENESIN LIQUID [KESIN PHARMA CORPORATION]	1	Current NDC, 1 package rows	20250406_31b8ad0a-3637-03db-e063-6394a90acdc3.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 165 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dimetapp Cough and Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Foundation Consumer Healthcare	15b0f5ff-202a-d19f-e063-6394a90af2b8	2024-04-15	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	P & L Development, LLC	8d27b94d-23a1-4e6c-a064-79e2580f7e2e	2024-04-15	Warnings	Exact identifier application number: M012
Severe Cold and Cough Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	2af496a1-6fdd-4acf-9944-8b7cdf302275	2024-04-15	Warnings	Exact identifier application number: M012
Childrens Dye Free Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	P & L Development, LLC	1c4d09ed-4e0f-430d-b17f-6a23f996a55d	2024-04-15	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Nighttime Value Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	9736ad4c-8c2e-421f-b023-f91b72d2828b	2024-04-10	Warnings	Exact identifier application number: M012
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	2024-04-10	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE	Harris Teeter, LLC	ec603195-eb36-4b5c-bc9b-c2074205b2b2	2024-04-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	9b0648ac-0ce3-4eaa-8977-26ae864f034d	2024-04-09	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	f147d82e-4429-4c7b-bd2b-e21a09f21c92	2024-04-09	Warnings	Exact identifier application number: M012
FLONASE Headache and Allergy Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Haleon US Holdings LLC	282c103c-3888-4a35-a5b1-d492ed6892c1	2024-04-08	Warnings	Exact identifier application number: M012
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	4908b326-e1da-44ca-8087-7e41a16c27b0	2024-04-08	Warnings	Exact identifier application number: M012
Robitussin Direct Sore Throat Pain	ACETAMINOPHEN	Haleon US Holdings LLC	1b512078-24c3-4b80-8f2c-d6824d367f25	2024-04-08	Warnings	Exact identifier application number: M012
Mucus Relief Cough Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN	H E B	9ba5ca1b-2e3c-439e-8887-c26f144b88ef	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	12ace982-bd47-49b0-ba1b-e0a29d42f1d6	2024-04-08	Warnings	Exact identifier application number: M012
Allergy Childrens	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	ab28cbc4-7a6f-46e9-8616-be78e8cb24fe	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	bd19b1f2-d9d3-4dab-8181-605f769ab62f	2024-04-08	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	9f533092-060c-4379-9a77-ecfea8aa46e1	2024-04-08	Warnings	Exact identifier application number: M012
Robitussin Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	66360295-f364-479a-8b49-c12b21918279	2024-04-06	Warnings	Exact identifier application number: M012
Robitussin Peak Cold Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	8c0a2424-e8ac-d91c-b46d-a5ee29f91936	2024-04-06	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	e7cf7c5d-5c9a-4201-9e30-1cd616071855	2024-04-06	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	365c01b7-a197-4876-85fc-42204f787e3a	7
310604	guaifenesin 20 MG/ML Oral Solution	SCD	365c01b7-a197-4876-85fc-42204f787e3a	7
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	365c01b7-a197-4876-85fc-42204f787e3a	7
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	365c01b7-a197-4876-85fc-42204f787e3a	7
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	365c01b7-a197-4876-85fc-42204f787e3a	7
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	365c01b7-a197-4876-85fc-42204f787e3a	7
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	365c01b7-a197-4876-85fc-42204f787e3a	7
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	31b8ad0a-3637-03db-e063-6394a90acdc3	1
310604	guaifenesin 20 MG/ML Oral Solution	SCD	31b8ad0a-3637-03db-e063-6394a90acdc3	1
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	31b8ad0a-3637-03db-e063-6394a90acdc3	1
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	31b8ad0a-3637-03db-e063-6394a90acdc3	1
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	31b8ad0a-3637-03db-e063-6394a90acdc3	1
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	31b8ad0a-3637-03db-e063-6394a90acdc3	1
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	31b8ad0a-3637-03db-e063-6394a90acdc3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81033-102-05	81033010205	5 mL in 1 CUP, UNIT-DOSE	5 ml				Historical
81033-102-10	81033010210	10 mL in 1 CUP, UNIT-DOSE	10 ml				Historical
81033-102-16	81033010216	473 mL in 1 BOTTLE (81033-102-16)	473 ml	2025-04-01	No	No	Current
81033-102-51	81033010251	50 CUP, UNIT-DOSE in 1 CARTON (81033-102-51) / 5 mL in 1 CUP, UNIT-DOSE (81033-102-05)		2023-11-20	No	No	Current
81033-102-52	81033010252	50 CUP, UNIT-DOSE in 1 CARTON (81033-102-52) / 10 mL in 1 CUP, UNIT-DOSE (81033-102-10)		2023-11-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin Oral Solution, USP	KESIN PHARMA CORPORATION \| Kesin Pharma	2025-04-01	HUMAN OTC DRUG LABEL	1
Guaifenesin Oral Solution, USP	KESIN PHARMA CORPORATION \| Kesin Pharma \| Belleview Biosciences	2025-03-28	HUMAN OTC DRUG LABEL	7