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 57 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREEN COMPANY	5bf72e2f-15c8-466a-9e13-50654233da91	2026-01-19	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreens	9862f84d-1c18-4ef7-86dc-98572599d417	2026-01-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	37853689-c9ca-4bc7-9c5b-4a68b8d778be	2026-01-19	Warnings	Exact identifier application number: M012
VAPORX	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	AKRON PHARMA INC	51b32162-0c5a-4b5b-999a-34337d816603	2026-01-19	Warnings	Exact identifier application number: M012
Equate	OXYMETAZOLINE HCL	Walmart Inc	2f762c24-2442-506a-e063-6394a90a3b96	2026-01-19	Warnings	Exact identifier application number: M012
Dimetane	DIPHENHYDRAMINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f	2026-01-19	Warnings	Exact identifier application number: M012
nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Publix Super Markets Inc	f681d986-9838-42d8-8ed9-732a39fbf870	2026-01-19	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	H E B	22d241c5-a3fd-4619-8147-91d7a4c8cf98	2026-01-19	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	Better Living Brands, LLC	9fe63ca6-3863-4175-9aec-ecd6ebbdb249	2026-01-19	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Night Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amerisource Bergen	5749ce9d-e182-478f-ab88-b520a35a99a7	2026-01-19	Warnings	Exact identifier application number: M012
Foster and Thrive Daytime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Strategic Sourcing Services LLC	1d9150b1-2f6c-4c33-8c93-3ed1d88585e2	2026-01-18	Warnings	Exact identifier application number: M012
HealthWise Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	ce3ceffd-3ff5-3795-e053-2995a90a827f	2026-01-18	Warnings	Exact identifier application number: M012
topcare nite time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Topco Associates LLC	31210a95-f9dc-49db-aab5-25c4dca49266	2026-01-17	Warnings	Exact identifier application number: M012
Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f77226c0-b6d5-9fd0-e053-6294a90a4b57	2026-01-16	Warnings	Exact identifier application number: M012
Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f691734b-5cf4-6eb8-e053-2a95a90aee80	2026-01-16	Warnings	Exact identifier application number: M012
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f771aa19-295a-9f4e-e053-6294a90a1674	2026-01-16	Warnings	Exact identifier application number: M012
CVS Cherry Cough Drops	MENTHOL	CVS Pharmacy	de5c4b94-0420-5d43-e053-2995a90aa5a5	2026-01-16	Warnings	Exact identifier application number: M012
CVS Honey Lemon Cough Drops	MENTHOL	CVS Pharmacy	de963dc3-8108-440f-e053-2995a90a906f	2026-01-16	Warnings	Exact identifier application number: M012
CVS SF Menthol Cough Drops	MENTHOL	CVS Pharmacy	e08f8ca3-b683-4964-e053-2a95a90afabb	2026-01-16	Warnings	Exact identifier application number: M012
CVS SF Honey Lemon Cough Drops	MENTHOL	CVS Pharmacy	e0cdeccf-c32f-318a-e053-2a95a90ac401	2026-01-16	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