FDA.reportPublic FDA data

Mucus Relief

Product NDC
71679-119
11-digit product format
716790119
Labeler code
71679
Product ID
71679-119_55feab68-a22d-b260-e063-6294a90ad86a
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin 400 mg
Dosage form
TABLET
Route
ORAL
Labeler
Health Pharma USA LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-18
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
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
d60a3e9d-e88e-3b19-e053-2995a90a3e8dAvailable 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
71679-119-02Mucus Relief200 in 1 BOTTLETABLET20011
71679-119-60Mucus Relief60 in 1 BOTTLETABLET6011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71679-119MUCUS RELIEF (GUAIFENESIN 400 MG) TABLET [HEALTH PHARMA USA LLC]3Current NDC, Legacy NDC, 2 package rows20231031_d60a3e9d-e88e-3b19-e053-2995a90a3e8d.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 170 of 174 · 3,464 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and Flu Severe, Caseys 4googACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATEDLil' Drug Store Products, Inc.0334259d-587e-b2d5-e063-6394a90a3e562023-11-14WarningsExact identifier
application number: M012
Stona CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSato Pharmaceutical Co., Ltd.0b638db4-5ed3-4665-abcd-f95e677adbd82023-11-12WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc6c90b415-4c5f-49e5-beb6-4cf225797b212023-11-06WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc8b8582c0-8aef-482f-9738-2f1d4e325d642023-11-06WarningsExact identifier
application number: M012
Cold and Flu Severe Daytime/NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATETopco Associates LLC27ade5f8-2003-4dc6-9244-42676791e1f82023-11-06WarningsExact identifier
application number: M012
Benadryl Allergy UltratabDIPHENHYDRAMINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Incec2070df-8a8a-4cd1-8830-62655433fb3b2023-11-05WarningsExact identifier
application number: M012
Daytime Nighttime Ultra Concentrated Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION093eed84-79b1-7914-e063-6394a90a37af2023-11-03WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff68377-2273-6c6c-e053-2995a90a36b22023-11-03WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLC096bbcaa-fce1-0fc2-e063-6294a90ad5972023-11-03WarningsExact identifier
application number: M012
TopCare Nite Time SEVERE Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCadc8edf5-ebbe-4d94-9018-aa0dbe1181122023-11-03WarningsExact identifier
application number: M012
MUCOSAGUAIFENESINTIME CAP LABORATORIES,INCd34ef2e8-adc2-48e5-a572-e354937daec62023-11-02WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe cold and fluDAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION09286d15-b63f-a9de-e063-6294a90ab9482023-11-02WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6cece6c-23e4-7811-e053-6394a90a106a2023-11-02WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.eb64750f-19ac-655f-e053-2995a90a33b52023-11-02WarningsExact identifier
application number: M012
Multi-Symptom Mapap Cold FormulaACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLProficient Rx LP9bf81b26-38b4-486c-ae89-222119ce1a4f2023-11-01WarningsExact identifier
application number: M012
Guaifenesin Syrup and DextromethorphanGUAIFENESIN SYRUP AND DEXTROMETHORPHANNatco Pharma USA LLCad9026f4-f0b6-4d02-aa44-f0460eeefc0e2023-11-01WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HYDROCHLORIDENatco Pharma USA LLC54b64354-ac10-42ff-a53d-96cef933a91a2023-11-01WarningsExact identifier
application number: M012
children allergy relief dye free cherryDIPHENHYDRAMINE HCLA-S Medication Solutions5c6c1809-4c6f-4e8f-a5ae-9796e821d4002023-11-01WarningsExact identifier
application number: M012
Daytime and Nighttime Cherry Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0903b222-1a44-64aa-e063-6294a90abba02023-10-31WarningsExact identifier
application number: M012
Ephrine Nose DropsPHENYLEPHRINE HYDROCHLORIDEWalgreensb620eb9f-2caf-0942-e053-2a95a90ae48e2023-10-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSNd60a3e9d-e88e-3b19-e053-2995a90a3e8d11
359601guaifenesin 400 MG Oral TabletSCDd60a3e9d-e88e-3b19-e053-2995a90a3e8d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71679-119-0271679011902200 TABLET in 1 BOTTLE (71679-119-02) 200 tablet2025-06-180000-00-00NoNoCurrent
71679-119-607167901196060 TABLET in 1 BOTTLE (71679-119-60) 60 tablet2025-06-18NoNoCurrent