FDA.reportPublic FDA data

MUCUS RELIEF

Product NDC
57896-718
11-digit product format
578960718
Labeler code
57896
Product ID
57896-718_5c28efd3-a29a-fa58-e063-6394a90a286d
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Geri-Care Pharmaceuticals, Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-01
Substance
GUAIFENESIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
MUCUS RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1

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 144 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcared6e789c7-a55a-dc9a-e053-2a95a90a2bdb2024-10-29WarningsExact identifier
application number: M012
Careone daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAmerican Sales Company31187c98-6706-4962-91f6-022a390cda392024-10-28WarningsExact identifier
application number: M012
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC0100f86e-257f-4197-9849-3c4429cdf0f22024-10-28WarningsExact identifier
application number: M012
Premier Value Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINPHARMACY VALUE ALLIANCE LLC46bf124a-a44f-4066-b936-852d46da8f402024-10-28WarningsExact identifier
application number: M012
Signature Care Non drowsy Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafeway25a26577-a9f8-49cb-9d75-d8c471e4aaf62024-10-28WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e2024-10-28WarningsExact identifier
application number: M012
Leader Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leaderd38537c6-9553-4e93-a83e-11ed48c955ab2024-10-28WarningsExact identifier
application number: M012
Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy2b3a1997-f382-4843-a44b-d80d1ad21a902024-10-28WarningsExact identifier
application number: M012
Premier Value Tussin Cough Long ActingDEXTROMETHORPHAN HBRChain Drug Consortium, LLC0e393287-5bb8-458b-98c4-55fa16674d062024-10-28WarningsExact identifier
application number: M012
daytime cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.1740ccfc-6e68-46f4-a1ba-48fe092f0aa02024-10-28WarningsExact identifier
application number: M012
night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.d3bd0632-328c-4ad7-bb44-8383e1e51b8c2024-10-28WarningsExact identifier
application number: M012
Premier ValueDEXTROMETHORPHAN HBR, GUAIFENESINPHARMACY VALUE ALLIANCE LLC1ae3c6ac-1646-4c67-a9d5-9c383924b81a2024-10-28WarningsExact identifier
application number: M012
nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy1c341cf5-ac33-4a6e-b023-a23d280d496c2024-10-25WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companyb6d9f421-b236-4660-be7f-85a878f2fc612024-10-25WarningsExact identifier
application number: M012
COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEFACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEChain Drug Consortium, LLCf9c3c12b-4efa-4ec4-a156-c403aff817532024-10-24WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEChain Drug Consortium, LLC1deb60f3-e9be-4756-b0c1-527ef00dc7412024-10-24WarningsExact identifier
application number: M012
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.51dd467b-aae8-41fa-e054-00144ff8d46c2024-10-24WarningsExact identifier
application number: M012
Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC68a5930b-37db-439d-8fb9-7d7de07d84652024-10-24WarningsExact identifier
application number: M012
sinus pressure pain and coughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INCbb0225d5-6c32-2c64-e053-2995a90a829b2024-10-24WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC01e1ad15-0ef5-4d6a-a9c1-19a5f2b201482024-10-24WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57896-718-0157896071801100 TABLET in 1 BOTTLE (57896-718-01) 100 tablet2026-08-01NoNoCurrent