MUCUS RELIEF

Product NDC
57896-794
11-digit product format
578960794
Labeler code
57896
Product ID
57896-794_284e3828-f883-997b-e063-6394a90ac514
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
2004-01-01
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57896-79457896-794-03DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
bb72de5d-d3c0-42fc-ae52-a3ad95214af5Available 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, Related label table
NDCEffectiveRelated label
57896-794-012021-02-15gc 794
57896-794-032021-02-15gc 794
57896-794-062021-02-15gc 794
57896-794-012021-01-29gc 794
57896-794-032021-01-29gc 794
57896-794-062021-01-29gc 794

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-794-01MUCUS RELIEF100 in 1 BOTTLETABLET1007
57896-794-03MUCUS RELIEF30 in 1 BOTTLETABLET307
57896-794-06MUCUS RELIEF60 in 1 BOTTLETABLET607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-794-01EA - Each57896-794381f87a8-ebdd-4389-b7c5-565cac8683b112013-08-02
57896-794-06EA - Each57896-7949cd46e8c-842e-43bc-84f6-792f6156e49512018-12-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-794MUCUS RELIEF (GUAIFENESIN) TABLET [GERI-CARE PHARMACEUTICALS, CORP]7Current NDC, Legacy NDC, 3 package rows20241204_bb72de5d-d3c0-42fc-ae52-a3ad95214af5.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 48 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME CHERRY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.36924420-f514-4225-e063-6294a90a330c2026-03-03WarningsExact identifier
application number: M012
Daytime Nighttime Ultra ConcentratedDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS HEALTH CORP4584d701-5a4e-e54e-e063-6394a90a38d62026-03-03WarningsExact identifier
application number: M012
foster and thrive nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESportpharm LLC7bdfd2ef-bb99-41f5-97ae-3a02c994bddd2026-03-03WarningsExact identifier
application number: M012
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLCd27b5976-8cc0-4d99-96f6-9069b786affd2026-03-03WarningsExact identifier
application number: M012
Tusnel EXGUAIFENESINA-S Medication Solutions7f703c9c-2256-4524-9d31-c51919399d262026-03-03WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)f49f1e9a-07ac-443e-9df8-3281d5f35e782026-03-03WarningsExact identifier
application number: M012
berkley and jensen nasalOXYMETAZOLINE HYDROCHLORIDEBJWC77cbe75d-4ed9-4a8b-91dc-1cc28af255082026-03-02WarningsExact identifier
application number: M012
childrens cold and cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWalgreen Company6c7c950d-ed48-4428-9e9e-73684cabc6992026-02-28WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Kroger Co.116146db-719f-4c48-8a8a-1120ea62b0d52026-02-27Warnings, Adverse reactionsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.1f737b76-14b5-618a-e063-6294a90a19c22026-02-27WarningsExact identifier
application number: M012
WALGREENS NIGHTTIME ALLERGY RELIEFDOXYLAMINE SUCCINATEWALGREENS CO.a3c7df98-4611-4b61-9c03-5e687364bf742026-02-27WarningsExact identifier
application number: M012
MEIJER Childrens Allergy Relief ChewsDIPHENHYDRAMINE HCLMEIJER DISTRIBUTION INC3368e081-a3b2-4c03-8bd1-05cc6af0391d2026-02-27WarningsExact identifier
application number: M012
CVS PHARMACY Nighttime MS Flu ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY23cafaa1-34fe-4cef-960b-5f664ea32cb42026-02-27WarningsExact identifier
application number: M012
Tussin DM Cough and ChestDEXTROMETHORPHAN HBR, GUAIFENESINWinCo Foods, LLC402969c9-945c-44b7-b018-b62f427ce5712026-02-26WarningsExact identifier
application number: M012
nasal originalOXYMETAZOLINE HYDROCHLORIDEHyVee Incd997f264-1b4a-4cca-a282-bd9645d55bfd2026-02-26WarningsExact identifier
application number: M012
Multi-Symptom Cold and Fever ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY2a569e47-3f17-4fc7-83d6-a3dddfd4987e2026-02-25WarningsExact identifier
application number: M012
Cough and Chest Congestion DN, Cough DM Daytime, NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED184059b7-9238-480e-be4a-ed105f13c19d2026-02-25WarningsExact identifier
application number: M012
Kids Daytime Cough and Nighttime Cough combo packDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATEGenexa Inc.4bad39f1-86d4-b8a1-e063-6394a90a7a952026-02-25WarningsExact identifier
application number: M012
dimaphen dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMajor Pharmaceuticals67072a38-1ae7-4e59-bfed-71db0d93215d2026-02-25WarningsExact identifier
application number: M012
leader tussin cfACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderb3e3699b-b36c-453c-8f3b-0001388c8e822026-02-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSN9ed5611f-4e1d-4f71-b430-a2a949bf7fe58
359601guaifenesin 400 MG Oral TabletSCD9ed5611f-4e1d-4f71-b430-a2a949bf7fe58
359601guaiFENesin 400 MG Oral TabletPSNbb72de5d-d3c0-42fc-ae52-a3ad95214af57
359601guaifenesin 400 MG Oral TabletSCDbb72de5d-d3c0-42fc-ae52-a3ad95214af57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-794-0157896079401100 TABLET in 1 BOTTLE (57896-794-01) 100 tablet2012-01-010000-00-00NoNoCurrent
57896-794-035789607940330 TABLET in 1 BOTTLE (57896-794-03) 30 tablet2012-01-010000-00-00NoNoCurrent
57896-794-065789607940660 TABLET in 1 BOTTLE (57896-794-06) 60 tablet2018-09-010000-00-00NoNoCurrent