MUCOSA

Product NDC
49483-272
11-digit product format
494830272
Labeler code
49483
Product ID
49483-272_092526a7-c2e1-4cb5-e063-6394a90ac509
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
TABLET
Route
ORAL
Labeler
TIME CAP LABORATORIES,INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-16
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
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
MUCOSA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1

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
359601Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d34ef2e8-adc2-48e5-a572-e354937daec6Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-272-00MUCOSA100000 in 1 CARTONTABLET1000005
49483-272-06MUCOSA60 in 1 BOTTLE, PLASTICTABLET605
49483-272-20MUCOSA200 in 1 BOTTLETABLET2005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-272-06EA - Each49483-27258558786-c85e-40fc-96a2-3b3579028fcd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCOSA (GUAIFENESIN) TABLET [AVPAK]2
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]2
GUAIFENESINACTIVE MOIETY495W7451VQMUCOSA (GUAIFENESIN) TABLET [AVPAK]2
GUAIFENESINACTIVE MOIETY495W7451VQMUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCOSA (GUAIFENESIN) TABLET [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCOSA (GUAIFENESIN) TABLET [AVPAK]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCOSA (GUAIFENESIN) TABLET [AVPAK]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EMUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]2
PovidonesINACTIVE INGREDIENTFZ989GH94EMUCOSA (GUAIFENESIN) TABLET [AVPAK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCOSA (GUAIFENESIN) TABLET [AVPAK]2
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2MUCOSA (GUAIFENESIN) TABLET [AVPAK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCOSA (GUAIFENESIN) TABLET [AVPAK]2
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCUS RELIEF (GUAIFENESIN) TABLET [MAJOR PHARMACEUTICALS INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCUS RELIEF (GUAIFENESIN) TABLET [CLINICAL SOLUTIONS WHOLESALE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-272MUCOSA (GUAIFENESIN) TABLET [TIME CAP LABORATORIES,INC]5Current NDC, Legacy NDC, 3 package rows20231102_d34ef2e8-adc2-48e5-a572-e354937daec6.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 24 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Runny Nose Childrens PlusACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDETOP CARE (Topco Associates LLC)6f04bd51-093c-4624-aef3-0145ac3873862026-06-01WarningsExact identifier
application number: M012
NasalPHENYLEPHRINE HYDROCHLORIDECVS Pharmacy694a3116-1b75-42cd-bbcf-d19831c2d7962026-06-01WarningsExact identifier
application number: M012
night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH E Bcf31538c-9eee-4c81-80cb-66eecabf0aff2026-06-01WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC155e07b3-0a08-3be8-e063-6394a90a76352026-05-31WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough NighttimeDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC156033ae-b16a-007b-e063-6294a90a74452026-05-31WarningsExact identifier
application number: M012
Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyebf8c82d-a653-4c02-893b-61704901acbb2026-05-29WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLAmerisource Bergen934c7b91-3cba-47f0-8efa-77216f3f15c42026-05-29WarningsExact identifier
application number: M012
Allergy MedicineDIPHENHYDRAMINE HCLCOSTCO WHOLESALE CORPORATIONd9f03e11-d11f-43ee-8ed0-9e07d1058f662026-05-29WarningsExact identifier
application number: M012
Cold Childrens, Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYeaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d2026-05-29WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC3598ac5b-29f9-f002-e063-6294a90a62cb2026-05-28WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC51badd2f-4a43-3dbe-e063-6294a90a4bd12026-05-28WarningsExact identifier
application number: M012
Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.a7ab2140-de09-158f-e053-2a95a90a25a02026-05-28WarningsExact identifier
application number: M012
Kids Multi Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.2d918ec8-3098-1d09-e063-6294a90a9e8f2026-05-28WarningsExact identifier
application number: M012
Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLGenexa Inc.213fe898-dace-9a0f-e063-6394a90afd642026-05-28WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey Lemon FlavorMENTHOLMedical Group Care LLC556628ab-e233-92fe-e063-6394a90a00902026-05-28WarningsExact identifier
application number: M012
Sinus Decongestion PEPHENYLEPHRINE HCLKroger Company68eff734-177e-4999-9126-6b92bb2041072026-05-28WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRARMY AND AIR FORCE EXCHANGE SERVICEff39084f-ab2f-48ed-ac62-837f7fff2b652026-05-28WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group LLC52c5fda0-c358-72e8-e063-6394a90a3f682026-05-27WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo PackDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC16637d54-8049-d3ce-e063-6394a90aafc92026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC00689aa5-ed39-4c9a-92b8-105d2c0e2e152026-05-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSNd34ef2e8-adc2-48e5-a572-e354937daec65
359601guaifenesin 400 MG Oral TabletSCDd34ef2e8-adc2-48e5-a572-e354937daec65
359601guaiFENesin 400 MG Oral TabletPSN33f9c655-87f5-4cbb-889f-fbb3f376b09d4
359601guaifenesin 400 MG Oral TabletSCD33f9c655-87f5-4cbb-889f-fbb3f376b09d4
359601guaiFENesin 400 MG Oral TabletPSN73f68f97-ad3a-492b-a96d-304b464ffd031
359601guaifenesin 400 MG Oral TabletSCD73f68f97-ad3a-492b-a96d-304b464ffd031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-272-0049483027200100000 TABLET in 1 CARTON (49483-272-00) 100000 tablet2012-04-160000-00-00NoNoCurrent
49483-272-064948302720660 TABLET in 1 BOTTLE, PLASTIC (49483-272-06) 60 tablet2012-04-160000-00-00NoNoCurrent
49483-272-2049483027220200 TABLET in 1 BOTTLE (49483-272-20) 200 tablet2023-09-15NoNoCurrent