FDA.reportPublic FDA data

Guaifenesin

Product NDC
60687-863
11-digit product format
606870863
Labeler code
60687
Product ID
60687-863_24b1b6f4-c113-8adc-e063-6394a90a546c
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-20
Substance
GUAIFENESIN
Active strength
200 mg/10mL
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
GUAIFENESIN200 mg/10mL

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
2fd702ea-3069-472c-b99e-c527f1375705Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-863-42Guaifenesin10 mL in 1 CUP, UNIT-DOSESOLUTION101
60687-863-48Guaifenesin10 in 1 TRAYSOLUTION101
60687-863-56Guaifenesin10 in 1 CASESOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-863-42ML - Milliliter60687-86316653323-3699-46bd-ad9d-7089cdb291dd12024-11-05
60687-863-56ML - Milliliter60687-863ad69ee57-8bbc-4475-9837-f199a46433c212024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-863GUAIFENESIN SOLUTION [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20241021_2fd702ea-3069-472c-b99e-c527f1375705.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 85 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLWALGREENS CO.bfc58cd5-9815-43af-895d-ec6cbd10937e2025-11-26WarningsExact identifier
application number: M012
Walgreen Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREEN COMPANY40c038a3-91c7-4ed0-8210-65d58b82ca2b2025-11-26WarningsExact identifier
application number: M012
Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINWALGREENS CO724554ab-60b8-46c8-96a8-a98242604e3b2025-11-26WarningsExact identifier
application number: M012
Walgreens Grape FlavorCHILDREN COUGH AND CHEST CONGESTIONWALGREENS795cf1af-3847-46bc-b605-64a38e57cca22025-11-26WarningsExact identifier
application number: M012
WalgreensCHILDRENS STUFFY NOSE AND COLDWALGREENS CO.7ac3de2d-1d10-49ec-a2da-da46977684ad2025-11-26WarningsExact identifier
application number: M012
Childrens Chest Congestion ReliefGUAIFENESINWALGREENS COMPANYc1382512-e6f3-4bdf-a9e6-4f68dd5ea5532025-11-26WarningsExact identifier
application number: M012
Dye Free Wal Sleep ZDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN CO.96948973-09e3-4c05-8982-0494ebeaac4b2025-11-26WarningsExact identifier
application number: M012
WALGREEN ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREEN COMPANY02ad9f98-07ad-4786-a1ab-169b870fec012025-11-26WarningsExact identifier
application number: M012
Walgreen CherryGUAIFENESINWALGREEN COMPANY1f1cb4a5-1ebd-483c-bf82-16931da00e052025-11-26WarningsExact identifier
application number: M012
Walgreen Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.801880b2-6116-4d26-a7bf-a669eef6ad8b2025-11-26WarningsExact identifier
application number: M012
Walgreen Daytimel Kids Cold Cough plus MucusGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.452159e0-1204-460c-981f-cace4e815c6f2025-11-26WarningsExact identifier
application number: M012
Multi Symptom Wal Flu Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWALGREEN CO.9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb2025-11-25WarningsExact identifier
application number: M012
WALGREEN Daytime Multi Symptom Flu Relief Max StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBRWALGREENS CO.c92a0f47-0b7c-4034-83d1-b7d2ed8022fc2025-11-25WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINWALGREENS CO.428081f5-b7eb-42da-963c-a587a44b2a792025-11-25WarningsExact identifier
application number: M012
Walgreen NightTime Cold and Flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWALGREENS CO.6b3766e6-d0d4-49e0-90da-fc893aef33292025-11-25WarningsExact identifier
application number: M012
Adult Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANY586310f3-0014-4cfc-9d86-961b3fb7aa8c2025-11-25WarningsExact identifier
application number: M012
childrens Allergy Dye Free Wal DrylDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN CO.4e64e040-1662-4dc9-b33f-3e119e0b3f7b2025-11-25WarningsExact identifier
application number: M012
WalgreenNASALWALGREENS COd38f8406-d7b9-472c-a472-58968bbdb9932025-11-25WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC780907b8-34ba-4ec8-bcdf-b2a31bd111df2025-11-25WarningsExact identifier
application number: M012
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCd13efbcd-1277-45d0-8389-1ba0337f7a242025-11-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN2fd702ea-3069-472c-b99e-c527f13757051
310604guaifenesin 20 MG/ML Oral SolutionSCD2fd702ea-3069-472c-b99e-c527f13757051
310604guaifenesin 100 MG per 5 ML Oral SolutionSY2fd702ea-3069-472c-b99e-c527f13757051
310604guaifenesin 100 MG per 5 ML Oral SyrupSY2fd702ea-3069-472c-b99e-c527f13757051
310604guaifenesin 200 MG per 10 ML Oral SolutionSY2fd702ea-3069-472c-b99e-c527f13757051
310604guaifenesin 300 MG per 15 ML Oral SolutionSY2fd702ea-3069-472c-b99e-c527f13757051
310604guaifenesin 400 MG per 20 ML Oral SolutionSY2fd702ea-3069-472c-b99e-c527f13757051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-863-426068708634210 mL in 1 CUP, UNIT-DOSE10 mlHistorical
60687-863-486068708634810 in 1 TRAYHistorical
60687-863-566068708635610 TRAY in 1 CASE (60687-863-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-863-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-863-42) 10 tray2024-10-20NoNoCurrent