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 169 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Sinus Relief Mist	OXYMETAZOLINE SPRAY	Walgreens Company	847f47d9-62b1-49a3-8bb3-9bf275685bd2	2024-02-14	Warnings	Exact identifier application number: M012
Allergy Sinus, Lil Drug Store	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE	Lil' Drug Store Products, Inc.	1145440e-b37a-6e5e-e063-6294a90ab4a0	2024-02-13	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	A-S Medication Solutions	36140639-e7a8-43bc-83e2-469430af9d1a	2024-02-13	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	ff48b55a-0d32-47d6-941d-d99c7cf52f94	2024-02-12	Warnings	Exact identifier application number: M012
Childrens Robitussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	15950273-14c9-4a0b-bbb4-683048add722	2024-02-08	Warnings	Exact identifier application number: M012
THERAFLU Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	7d902237-a990-4c5e-875b-291e124e143b	2024-02-03	Warnings	Exact identifier application number: M012
Tussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Best Choice (Valu Merchandisers Company)	0f2d371d-f890-41e5-ac11-db5559d32466	2024-02-02	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	4daca846-8511-4303-9e6c-9469f7f260ba	2024-02-02	Warnings	Exact identifier application number: M012
CVS Health COUGH SUPPRESSANT SOFTGEL	DEXTROMETHORPHAN HYDROBROMIDE	CVS Pharmacy, Inc.	f676dfeb-fba8-419d-8a47-c3880e4100cc	2024-02-02	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu ReadyInCase	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	P & L Development, LLC	155a7168-b568-41f4-b8a2-214889b4eccf	2024-02-02	Warnings	Exact identifier application number: M012
Vaporizing Chest Rub Lavender 4oz	CAMPHOR/MENTHOL	Rejoice International Corp.	104e1a38-3472-b9e2-e063-6294a90a38cf	2024-02-01	Warnings	Exact identifier application number: M012
Vaporizing Chest Rub Lavender 4oz	CAMPHOR/MENTHOL	China Ningbo Shangge Cosmetics Technology Corp.	104f5b07-eed2-566c-e063-6294a90a6505	2024-02-01	Warnings	Exact identifier application number: M012
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	5962a73e-72e4-493b-94a7-43bc6cf9c82f	2024-02-01	Warnings	Exact identifier application number: M012
good sense allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	L. Perrigo Company	2cfa69b4-e33f-442a-a6df-b021b041da14	2024-02-01	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2024-01-31	Warnings	Exact identifier application number: M012
SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	17a07d2d-f2da-4e51-9a77-6f0c174987bb	2024-01-31	Warnings	Exact identifier application number: M012
Maximum strength Max Cold and Sinus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	263dae13-5f92-4505-8bcc-e903d05b9a0c	2024-01-31	Warnings	Exact identifier application number: M012
THERAFLU POWERPODS NIGHTTIME SEVERE COLD	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	39f9feef-4bf2-4f10-9fff-22bbb1d8a471	2024-01-30	Warnings	Exact identifier application number: M012
Theraflu Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Haleon US Holdings LLC	c0689223-5c90-4dbc-bbfa-f94e267504c3	2024-01-28	Warnings	Exact identifier application number: M012
THERAFLU MULTI-SYMPTOM SEVERE COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	a4c56ca0-7785-404b-996d-137cc135f270	2024-01-28	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