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 30 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Fast-Max Severe Congestion and CoughGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC1991d5ee-fc90-4070-8965-cd6f4abc45cf2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3ba2cc08-acad-79a8-e063-6394a90af17f2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCa3523aa3-9ed1-472d-9986-438440d0a3eb2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC2ed3c844-0532-40d9-beba-738d196de34d2026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC1e243dbe-138f-4346-ba22-ceea01e970522026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCa14bc0d1-9b05-4a21-aaa8-95d4d073b9ed2026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC128f3442-9802-4303-80be-aead092379362026-05-13WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and CoolOXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC33f0d9bb-c67d-92ba-e063-6294a90a99432026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and Pain, Maximum StrengthACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC2c01962d-74e3-4dfa-b7cb-a91a687711d52026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCf5365c6d-9296-41a5-953a-d1008954e67f2026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8905706b-b9da-4520-8cf2-87d7c125edf32026-05-13WarningsExact identifier
application number: M012
MUCINEX Rapid Clear Day Night and Clear and Cool NasalACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC37dcb0ed-df56-1bec-e063-6394a90a695e2026-05-13WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and CoolOXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC373e0d75-8def-4b98-e063-6394a90a5e472026-05-13WarningsExact identifier
application number: M012
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASALOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC5a397466-8721-4060-a178-5ebfd7069cc92026-05-13WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, GUAIFENESINReckitt Benckiser LLC350764de-7801-b24e-e063-6394a90ab3c32026-05-13WarningsExact identifier
application number: M012
Cepacol Extra Strength Sore Throat and CoughBENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCc0cc32db-90f0-4106-8538-89821083ece12026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC316b5569-b66f-f30c-e063-6394a90ae1472026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCd9467ca2-df75-4fa1-92b3-d2101eb54a772026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC12420092-3ef6-464b-9106-2d56cd6ef2002026-05-13WarningsExact 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