FDA.reportPublic FDA data

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
IngredientStrength
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310604Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
365c01b7-a197-4876-85fc-42204f787e3aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-102-05Guaifenesin5 mL in 1 CUP, UNIT-DOSELIQUID57
81033-102-10Guaifenesin10 mL in 1 CUP, UNIT-DOSELIQUID107
81033-102-51Guaifenesin50 in 1 CARTONLIQUID507
81033-102-52Guaifenesin50 in 1 CARTONLIQUID507
81033-102-16Guaifenesin473 mL in 1 BOTTLELIQUID4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-102-05ML - Milliliter81033-102c04493a2-a5df-4be5-86e1-38cd698bbd6312024-03-12
81033-102-10ML - Milliliter81033-102a990cc84-2678-4699-8dca-ec8808a024a412024-04-05
81033-102-16ML - Milliliter81033-1027a1f8916-cb71-4e4c-a447-b4f532f27ea312025-06-13
81033-102-51ML - Milliliter81033-102118824ef-231f-4404-85a9-9e31242703de12024-01-04
81033-102-52ML - Milliliter81033-1020be6c67c-993a-4d6d-9ecc-515e876c5d3912024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-102GUAIFENESIN LIQUID [KESIN PHARMA CORPORATION]7Current NDC, 4 package rows20250331_365c01b7-a197-4876-85fc-42204f787e3a.zip
81033-102GUAIFENESIN LIQUID [KESIN PHARMA CORPORATION]1Current NDC, 1 package rows20250406_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 135 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.19898135-0f7b-45a5-a672-14c49fd210772024-12-02WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corpbb72de5d-d3c0-42fc-ae52-a3ad95214af52024-12-02WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAAA Pharmaceutical, Inc.a242e005-0330-4afb-83b8-13c7d56f5c6d2024-12-02WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC53b15e75-9efd-4b4b-834b-6e9f12c601082024-12-02WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Incf4468840-e17c-6888-e053-2995a90a04a02024-12-02WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corpac8a14ac-7023-1e23-e053-2995a90aea3a2024-11-28WarningsExact identifier
application number: M012
Childrens Benadryl DYE-FREE ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC10d478ff-ddc6-45da-87ff-cfe1b2b07a8e2024-11-27WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepack9cd10af6-a2fa-44f8-8df3-a6d2a95a52932024-11-27WarningsExact identifier
application number: M012
Severe Sinus Congestion Allergy and Cough FormulaACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC36a4ec1f-50c3-4d61-ada9-987ccad3563c2024-11-26WarningsExact identifier
application number: M012
Daytime Nighttime Childrens Multi-symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.177e3247-402d-98e4-e063-6294a90ae0682024-11-26WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and Flu, CVPCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLETLil' Drug Store Products, Inc.e7a27773-69d6-9e07-e053-2a95a90af8ea2024-11-25WarningsExact identifier
application number: M012
DayTime Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.4361912e-4b56-4743-b11d-acfb94482a2e2024-11-25WarningsExact identifier
application number: M012
NightTime Sinus ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.413d82d3-a896-4f15-9fca-c1b7b9a1ee632024-11-25WarningsExact identifier
application number: M012
Night Cold Flu Cough and AllergyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.590f4f0d-c8b0-412d-be1e-3eb2ccb29ac02024-11-25WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.cbd3a905-1c41-4cb0-8df6-36784430d6272024-11-25WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.7a28d0fe-0e0a-453a-b604-1cc784dd153c2024-11-25WarningsExact identifier
application number: M012
Cough and Cold plusACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltdc483d88f-cb0a-4dd6-b3ae-559521782ba62024-11-25WarningsExact identifier
application number: M012
DayTime SinusACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.a0b01aef-4248-4d41-862c-0c8884dfca5e2024-11-25WarningsExact identifier
application number: M012
DayTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.3af20739-6794-42e0-b404-3f0401d10a6d2024-11-25WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.ffc7e1e2-b664-461b-963d-764bad2f983f2024-11-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN365c01b7-a197-4876-85fc-42204f787e3a7
310604guaifenesin 20 MG/ML Oral SolutionSCD365c01b7-a197-4876-85fc-42204f787e3a7
310604guaifenesin 100 MG per 5 ML Oral SolutionSY365c01b7-a197-4876-85fc-42204f787e3a7
310604guaifenesin 100 MG per 5 ML Oral SyrupSY365c01b7-a197-4876-85fc-42204f787e3a7
310604guaifenesin 200 MG per 10 ML Oral SolutionSY365c01b7-a197-4876-85fc-42204f787e3a7
310604guaifenesin 300 MG per 15 ML Oral SolutionSY365c01b7-a197-4876-85fc-42204f787e3a7
310604guaifenesin 400 MG per 20 ML Oral SolutionSY365c01b7-a197-4876-85fc-42204f787e3a7
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN31b8ad0a-3637-03db-e063-6394a90acdc31
310604guaifenesin 20 MG/ML Oral SolutionSCD31b8ad0a-3637-03db-e063-6394a90acdc31
310604guaifenesin 100 MG per 5 ML Oral SolutionSY31b8ad0a-3637-03db-e063-6394a90acdc31
310604guaifenesin 100 MG per 5 ML Oral SyrupSY31b8ad0a-3637-03db-e063-6394a90acdc31
310604guaifenesin 200 MG per 10 ML Oral SolutionSY31b8ad0a-3637-03db-e063-6394a90acdc31
310604guaifenesin 300 MG per 15 ML Oral SolutionSY31b8ad0a-3637-03db-e063-6394a90acdc31
310604guaifenesin 400 MG per 20 ML Oral SolutionSY31b8ad0a-3637-03db-e063-6394a90acdc31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-102-05810330102055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-102-108103301021010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
81033-102-1681033010216473 mL in 1 BOTTLE (81033-102-16) 473 ml2025-04-01NoNoCurrent
81033-102-518103301025150 CUP, UNIT-DOSE in 1 CARTON (81033-102-51) / 5 mL in 1 CUP, UNIT-DOSE (81033-102-05) 2023-11-20NoNoCurrent
81033-102-528103301025250 CUP, UNIT-DOSE in 1 CARTON (81033-102-52) / 10 mL in 1 CUP, UNIT-DOSE (81033-102-10) 2023-11-20NoNoCurrent