FDA.reportPublic FDA data

Mucus Relief

Product NDC
69168-370
11-digit product format
691680370
Labeler code
69168
Product ID
69168-370_d968aa38-9d60-4ca2-adf3-68cf19534a6b
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-23
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
Brand name suffix
Immediate Release
Listing expiration
2027-12-31

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
221d64a2-b8c7-435a-aae4-fb58fd38108fAvailable 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
69168-370-01Mucus ReliefImmediate Release100 in 1 BOTTLETABLET1005
69168-370-02Mucus ReliefImmediate Release150 in 1 BOTTLETABLET1505
69168-370-17Mucus ReliefImmediate Release300 in 1 BOTTLETABLET3005
69168-370-30Mucus ReliefImmediate Release30 in 1 BOTTLETABLET305
69168-370-30Mucus ReliefImmediate Release1 in 1 CARTONTABLET15
69168-370-41Mucus ReliefImmediate Release15 in 1 BOTTLETABLET155
69168-370-41Mucus ReliefImmediate Release1 in 1 CARTONTABLET15
69168-370-60Mucus ReliefImmediate Release60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-370MUCUS RELIEF IMMEDIATE RELEASE (GUAIFENESIN) TABLET [ALLEGIANT HEALTH]5Current NDC, Legacy NDC, 8 package rows20231108_221d64a2-b8c7-435a-aae4-fb58fd38108f.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 117 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.87ebb4d9-78d7-1c87-e053-2a95a90adb7d2025-03-27WarningsExact identifier
application number: M012
REVASOL CHILDRENS ALLERGYDIPHENHYDRAMINE HCLRnv LLC3143137f-ef42-5358-e063-6394a90a8ed12025-03-26WarningsExact identifier
application number: M012
Rompe Pecho SF FLUDEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEEfficient Laboratories Incbc10695a-9664-4ce3-82bb-820da06129fa2025-03-26WarningsExact identifier
application number: M012
SUPRESS-PE PediatricGUIAFENESIN, PHENYLEPHRINE HCLKramer Novisa474171d-5c29-4a80-9d37-00613796211a2025-03-26WarningsExact identifier
application number: M012
Guaifenesin DMDEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESINInnovida Pharmaeutique Corporationdd3f806b-2470-4055-94e1-18adac8110252025-03-25WarningsExact identifier
application number: M012
Foster and Thrive childrens cold cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEStrategic Sourcing Services LLC38b710e3-1d01-4ff4-a6b6-44936f277f492025-03-25WarningsExact identifier
application number: M012
Revasol Tussin DM Max with HoneyDEXTROMETHORPHAN HBR AND GUAIFENESINRnv LLC30da9255-c93a-84d6-e063-6394a90a7c2a2025-03-21WarningsExact identifier
application number: M012
REVASOL NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATERnv LLC30dfd8f7-4cc6-d4f2-e063-6394a90aa9c92025-03-21WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINMeijer, Inc.261a79b3-5704-76f2-e063-6394a90a5ac62025-03-20WarningsExact identifier
application number: M012
Rompe Tos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cc932d-b412-0710-e063-6394a90a87f62025-03-19WarningsExact identifier
application number: M012
Rompe Tos X AdultsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05abb2db-d22e-90b5-e063-6294a90ace3f2025-03-19WarningsExact identifier
application number: M012
Sinus Head CongestionACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLC30a07773-bd6f-b9f2-e063-6394a90ab8aa2025-03-18WarningsExact identifier
application number: M012
Halls Sugar Free Black CherryMENTHOLMondelez Global LLCbd2a311a-bf0c-4365-af9b-76675c243b222025-03-16WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTARGET CORPORATIONfbca9627-5e12-048a-e053-6294a90a6e0f2025-03-15WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLDOLGENCORP, INC.0655688e-7c42-507f-e063-6294a90ae4982025-03-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY, INC1b8d5494-1fcf-4cd0-acc0-34f17d577bd72025-03-14WarningsExact identifier
application number: M012
Ultra Concentrated Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300b2357-933b-fe9a-e063-6294a90aa4b92025-03-11WarningsExact identifier
application number: M012
Ultra Concentrated Nighttime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEPuraCap Pharmaceutical LLC300bf27f-744f-7366-e063-6394a90acbcb2025-03-11WarningsExact identifier
application number: M012
Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300c7c7b-ea0b-3650-e063-6294a90a65e82025-03-11WarningsExact identifier
application number: M012
Rompe Pecho NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEFFICIENT LABORATORIES INC2ec319a8-92bf-4552-86dd-37cbce18980f2025-03-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSN221d64a2-b8c7-435a-aae4-fb58fd38108f5
359601guaifenesin 400 MG Oral TabletSCD221d64a2-b8c7-435a-aae4-fb58fd38108f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-370-0169168037001100 TABLET in 1 BOTTLE (69168-370-01) 100 tablet2014-12-230000-00-00NoNoCurrent
69168-370-0269168037002150 TABLET in 1 BOTTLE (69168-370-02) 150 tablet2023-11-06NoNoCurrent
69168-370-1769168037017300 TABLET in 1 BOTTLE (69168-370-17) 300 tablet2019-03-280000-00-00NoNoCurrent
69168-370-30691680370301 BOTTLE in 1 CARTON (69168-370-30) / 30 TABLET in 1 BOTTLE1 bottle2014-12-230000-00-00NoNoCurrent
69168-370-41691680370411 BOTTLE in 1 CARTON (69168-370-41) / 15 TABLET in 1 BOTTLE1 bottle2014-12-230000-00-00NoNoCurrent
69168-370-606916803706060 TABLET in 1 BOTTLE (69168-370-60) 60 tablet2022-06-080000-00-00NoNoCurrent