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 111 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC8188b66a-5405-4e62-bde6-63ebc1f22b162025-07-04WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEMeijer, Inc.fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a2025-07-03WarningsExact identifier
application number: M012
Cabinet Allergy Relief Refill Diphenhydramine HCIDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.d47553a4-ca15-4f0a-8177-d743a5c39cc52025-07-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAdvanced Rx LLC20e164b8-4cbc-cf3f-e063-6394a90a9d0c2025-07-02WarningsExact identifier
application number: M012
24/7 Life Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENTLil' Drug Store Products, Inc.f03430d4-8dbb-4fc0-e053-2a95a90a119d2025-07-02WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINKJD Pharma Private Limitedb109249a-a0be-41bd-b6ce-ef621b588ddc2025-07-02WarningsExact identifier
application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy91c803c8-6cf8-4ff6-b376-ea6d65f9f2272025-07-01WarningsExact identifier
application number: M012
WALGREENS Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALGREENS CO.cc2fdc6b-8319-47c8-b036-37dbd65d58332025-06-30WarningsExact identifier
application number: M012
WALGREENS Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALGREENS CO.91c369b0-8620-4764-a85d-a86402d9489c2025-06-30WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HCl 25mg SoftGelDIPHENHYDRAMINE HYDROCHLORIDEPioneer Life Sciences, LLCbb9a82b1-ea7a-4d10-bc00-05013e83c4d32025-06-30WarningsExact identifier
application number: M012
Daytime and Nighttime Cherry Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS, LLC202f0661-461c-0333-e063-6294a90a96b52025-06-28WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLCVS Pharmacyf038b713-0721-2bb5-e053-2a95a90a78422025-06-26WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HCl 25mg SoftGelDIPHENHYDRAMINE HYDROCHLORIDENUVICARE LLCbb728ceb-8eb0-4192-a8b0-742756819a052025-06-26WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDETIME CAP LABORATORIES, INC7aee34b5-1583-4a8a-8ffb-b17ef2722ac12025-06-25WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDEWALGREENSc0270298-e7c5-e500-e053-2995a90aed232025-06-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.24ff91f2-02db-56a2-e063-6394a90a31c92025-06-25WarningsExact identifier
application number: M012
Cough and Chest Congestion Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.e920b700-30d3-3266-e053-2a95a90a06392025-06-24WarningsExact identifier
application number: M012
good sense childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEL. Perrigo Company2ffe0fbc-236d-417b-bbfd-5b9294f3c90a2025-06-23WarningsExact identifier
application number: M012
Exchange Select Cough Drop Black Cherry Sugar FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.38034ad2-5eab-9caf-e063-6294a90abb8f2025-06-20WarningsExact identifier
application number: M012
Herbal Cough DropsHERBAL MENTHOLMeijer, Inc.380364be-4e52-fa52-e063-6394a90a713c2025-06-20WarningsExact 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