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 172 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	DeMoulas Market Basket	e92d2f64-9690-42d3-b787-cafade3a8999	2023-12-29	Warnings	Exact identifier application number: M012
Cold and Sinus Maxium Strength	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	6e5ca8e1-5a03-4e77-b385-d44387fb3bfc	2023-12-29	Warnings	Exact identifier application number: M012
Cold, Flu and Sore Throat Maxium Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	d98029c0-ccd9-47e1-996f-c7786cd4ecca	2023-12-29	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH Sinus Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	0f2be061-bd0a-4e62-b994-6d0768ea647a	2023-12-29	Warnings	Exact identifier application number: M012
Tussin CF Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	c19b9997-4037-48f3-b905-86da421a292d	2023-12-29	Warnings	Exact identifier application number: M012
HempNesic	MENTHOL, CAMPHOR	Blaine Labs Inc.	0239ada0-644d-4ef4-a3b8-df70246a3bc2	2023-12-21	Warnings	Exact identifier application number: M012
HempNesic	MENTHOL, CAMPHOR	Blaine Labs Inc.	a698502d-c1c5-41ca-8142-74338b834c8b	2023-12-21	Warnings	Exact identifier application number: M012
Father Johns Cough Medicine Plus	NASAL DECONGESTANT	Oakhurst Company	8b8aab0f-251b-6bd8-e053-2995a90ad748	2023-12-18	Warnings	Exact identifier application number: M012
Father Johns Medicine	DEXTROMETHORPHAN HBR	Oakhurst Company	8b8a249d-55af-cc98-e053-2995a90a431d	2023-12-18	Warnings	Exact identifier application number: M012
Daytime Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	e79d92d2-d73c-d44f-e053-2995a90a03d9	2023-12-15	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL TABLET	Lil' Drug Store Products, Inc.	e5339c39-1d66-b283-e053-2995a90a4317	2023-12-15	Warnings	Exact identifier application number: M012
Father Johns Medicine	DEXTROMETHORPHAN HBR	Humco Holding Group, Inc	a7b0669f-8da1-5a44-e053-2995a90a84d9	2023-12-15	Warnings	Exact identifier application number: M012
Ephedrine Hydrochloride	EPHEDRINE HYDROCHLORIDE	Walgreen Company	bcb81dc1-d854-30c0-e053-2a95a90a9fc7	2023-12-14	Warnings	Exact identifier application number: M012
Allergy, Circle K	DIPHENHYDRAMINE HCL 25MG TABLET	Lil' Drug Store Products, Inc.	d1f370ac-e7f4-baf7-e053-2995a90a1e50	2023-12-14	Warnings	Exact identifier application number: M012
Circle K Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	a6a1e3d9-575c-4adf-beb6-c9719de55c67	2023-12-14	Warnings	Exact identifier application number: M012
Non-Drowsy Sinus Severe, Circle K	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED	Lil' Drug Store products, Inc.	e78c456f-f62e-596d-e053-2995a90a2397	2023-12-14	Warnings	Exact identifier application number: M012
Non-Drowsy Max Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	e79f1a92-d8ea-e3f9-e053-2a95a90a2d37	2023-12-14	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Major Pharmaceuticals	bcc1a001-4176-485d-aaf0-2037ca65c6b8	2023-12-14	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Major Pharmaceuticals	edb49b17-06a7-4c25-bc7c-d62c1deac7f1	2023-12-13	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline No Drip	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	0c006b1c-8ab2-4b9c-8738-e7001c1bb47d	2023-12-11	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