FDA.reportPublic FDA data

Mucus Relief

Product NDC
82725-1012
11-digit product format
827251012
Labeler code
82725
Product ID
82725-1012_395687f6-95e4-578c-e063-6394a90a1e6a
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin 400 mg
Dosage form
TABLET
Route
ORAL
Labeler
Cabinet Health, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-01
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
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
Mucus Relief
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
26a51b0e-039c-663c-e063-6394a90ad384Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82725-1012-12025-08-04C16284748780-13b156c62-334c-fb37-e063-e6dba90a4e07ValuMeds Mucus Relief Caplets Guaifenesin 400mg
82725-1012-12025-07-29C16284748780-13b156c62-334c-fb37-e063-e6dba90a4e07ValuMeds Mucus Relief Caplets Guaifenesin 400mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82725-1012-1Mucus Relief200 in 1 BOTTLETABLET2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82725-1012MUCUS RELIEF (GUAIFENESIN 400 MG) TABLET [CABINET HEALTH, INC.]1Current NDC, 1 package rows20241114_26a51b0e-039c-663c-e063-6394a90ad384.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 156 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Exchange Select NasalOXYMETAZOLINE HCLArmy & Air Force Exchange Service40d2090d-c332-4dcb-9f43-5ee467e7b3d12024-08-27WarningsExact identifier
application number: M012
Signature Care Nasal DecongestantOXYMETAZOLINE HCLSafeway23f0a5b3-59ae-4eb3-9b7d-e6a4920603372024-08-27WarningsExact identifier
application number: M012
DG Health NasalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLCdebcda99-c605-4941-b873-9e4dbae274832024-08-27WarningsExact identifier
application number: M012
Good Neighbor Pharmacy NasalOXYMETAZOLINE HCLAmerisource Bergend374d697-2b57-4558-a20b-d3d89aea82d72024-08-27WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HCLMeijer Distribution Inc3984cbc3-b60c-40a7-bc3a-7d1f600503ac2024-08-27WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDEStrategic Sourcing Services LLCe6e51821-03ae-4ec3-82a9-b4a8feacd9962024-08-27WarningsExact identifier
application number: M012
Pyrilamine Maleate and Dextromethorphan HydrobromidePYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEWestminster Pharmaceuticals, LLCdd068449-9d24-41e6-8a6e-f69c9fe263f22024-08-26WarningsExact identifier
application number: M012
basic care nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCa154e500-2b45-4242-a26c-9530849f99df2024-08-23WarningsExact identifier
application number: M012
Daytime Nighttime Ultra Concentrated Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0c0cf76f-2dd3-45ef-e063-6394a90a9fef2024-08-22WarningsExact identifier
application number: M012
Day Cold and Flu and Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLTARGET CORPORATION08ee56d1-b11d-3e36-e063-6294a90acd5f2024-08-22WarningsExact identifier
application number: M012
Maximum Strength Daytime Cold and Flu and Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,TRIPROLIDINE HYDROCHLORIDETARGET CORPORATION0fc523ce-55a7-6384-e063-6394a90aad3f2024-08-22WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreens8045aef9-22bc-4146-b494-dbb1ffef06df2024-08-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.5a2053d4-9c0d-4613-9cf5-0067173f37302024-08-16WarningsExact identifier
application number: M012
QUALITY CHOICE Long Acting Cough SoftgelDEXTROMETHORPHAN HYDROBROMIDEChain Drug Marketing Association, Inc.f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c2024-08-16WarningsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLPadagis Israel Pharmaceuticals Ltd458594e1-8d99-4de3-8923-2fd8ce2fc4062024-08-16WarningsExact identifier
application number: M012
Halls Sugar Free Mountain MentholMENTHOLMondelez Global LLC54e0d57e-1f48-45e2-86b3-0e50775996f42024-08-15WarningsExact identifier
application number: M012
SanaTos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC1fc1408c-c540-39ab-e063-6394a90aa4772024-08-15WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.489645ad-d7da-5f52-e054-00144ff8d46c2024-08-14WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation6c949602-e0c8-40ce-8fb3-5147f406fa042024-08-14WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.3dbdf020-ca17-1197-e054-00144ff8d46c2024-08-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSN26a51b0e-039c-663c-e063-6394a90ad3842
359601guaifenesin 400 MG Oral TabletSCD26a51b0e-039c-663c-e063-6394a90ad3842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82725-1012-182725101201200 TABLET in 1 BOTTLE (82725-1012-1) 200 tablet2024-11-01NoNoCurrent