FDA.reportPublic FDA data

Mucus Relief

Product NDC
50804-371
11-digit product format
508040371
Labeler code
50804
Product ID
50804-371_cb111f90-011d-408b-a47e-afe230f649ac
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin 400mg
Dosage form
TABLET
Route
ORAL
Labeler
Good Sense
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief
Brand name suffix
Immediate Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui359601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-371-30Mucus ReliefImmediate Release30 in 1 BOTTLETABLET308
50804-371-30Mucus ReliefImmediate Release1 in 1 CARTONTABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-371MUCUS RELIEF IMMEDIATE RELEASE (GUAIFENESIN 400MG) TABLET [GOOD SENSE]8Current NDC, Legacy NDC, 2 package rows20231108_e7c68746-7ec0-46cf-b4a3-174fab819b5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSNe7c68746-7ec0-46cf-b4a3-174fab819b5e8
359601guaifenesin 400 MG Oral TabletSCDe7c68746-7ec0-46cf-b4a3-174fab819b5e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-371-30508040371301 BOTTLE in 1 CARTON (50804-371-30) / 30 TABLET in 1 BOTTLE1 bottle2021-05-050000-00-00NoNoCurrent