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 127 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levmetamfetamine	LEVMETAMFETAMINE	Meijer, Inc.	d11e916f-90a6-4099-bf83-75f2dfbd6266	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, DG health	LEVMETAMFETAMINE	Dolgencorp Inc.	5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd3	2024-12-20	Warnings	Exact identifier application number: M012
Tukol Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA, Inc.	aef2ad43-145d-4abc-bccc-2c5fdd6882f9	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, TopCare health	LEVMETAMFETAMINE	Topco Associates LLC	8f995561-759a-4837-a82a-640417a6f889	2024-12-20	Warnings	Exact identifier application number: M012
Childrens Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores, Inc.	50a0eaa5-fa73-4d84-86fc-3546c85cf353	2024-12-20	Warnings	Exact identifier application number: M012
Equate Childrens Multi symptom Cold Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler	LEVMETAMFETAMINE NASAL DECONGESTANT	C.D.M.A., Inc.	904b7e21-cce5-4b96-afc1-b36f532f98ac	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Equaline	LEVMETAMFETAMINE	Supervalu Inc.	44f72f34-d0b8-421f-b240-86286de874cf	2024-12-20	Warnings	Exact identifier application number: M012
Childrens Tussnex	ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	19e9678d-ac34-4af8-a80f-d08fce0a5f0e	2024-12-19	Warnings	Exact identifier application number: M012
Vaporising Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	New Pride Corp	f66476d5-036b-0b1c-e053-2a95a90a0a07	2024-12-19	Warnings	Exact identifier application number: M012
Chest Rub Vaporizing Action	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Singhfam Corporation	c6ea663a-9c4f-4d1a-a937-002806a8530a	2024-12-19	Warnings	Exact identifier application number: M012
ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION	CAMPHOR (SYNTHETIC), LEVOMENTHOL, EUCALYPTUS	Singhfam Corporation	f1e4caee-b50e-a0a6-e053-2a95a90aadce	2024-12-19	Warnings	Exact identifier application number: M012
Leader Vapor Steam camphor (synthetic)	CAMPHOR (SYNTHETIC)	LEADER/Cardinal Health 110, Inc.	ae580e6c-2efd-c788-e053-2995a90a3360	2024-12-19	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Strategic Sourcing Service, LLC	0b6689db-ea34-9a06-e063-6394a90abaf7	2024-12-19	Warnings	Exact identifier application number: M012
Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Jell Pharmaceuticals Pvt Ltd.	d80b9cc1-55f5-76d5-e053-2995a90aa967	2024-12-19	Warnings	Exact identifier application number: M012
Health Smart Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Home Smart Products	acab200e-48bd-69e1-e053-2995a90afde0	2024-12-19	Warnings	Exact identifier application number: M012
Halls MENTHO-LYPTUS	MENTHOL	Mondelez Global LLC	ff21cf0e-9811-4819-bdfc-17a950e9b114	2024-12-19	Warnings	Exact identifier application number: M012
Tussnex FM Cold, Flu and Sore Throat	ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	7bddce11-c227-4d95-94c1-6f41ecd7285b	2024-12-19	Warnings	Exact identifier application number: M012
Childrens Tussnex Multi-symptom cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	9028676e-d725-4afe-aa14-72235825aa17	2024-12-19	Warnings	Exact identifier application number: M012
Tussnex FM Cold and Sinus	ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	04c6bb6a-d2f8-4322-afba-e240e8090176	2024-12-19	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