FDA.reportPublic FDA data

Mucus Relief Extended Release

Product NDC
67296-1467
11-digit product format
672961467
Labeler code
67296
Product ID
67296-1467_2c62a349-2179-a29e-e063-6294a90a9926
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Redpharm Drug Inc.
Application
ANDA207342
Marketing category
ANDA
Marketing start
2018-08-31
Substance
GUAIFENESIN
Active strength
600 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 Extended Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1467-7Mucus Relief Extended Release1 in 1 BOTTLETABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1467MUCUS RELIEF EXTENDED RELEASE (GUAIFENESIN) TABLET [REDPHARM DRUG INC.]2Current NDC, 1 package rows20250124_f4c1e725-bcae-2255-e053-2995a90ad335.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNf4c1e725-bcae-2255-e053-2995a90ad3352
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDf4c1e725-bcae-2255-e053-2995a90ad3352
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYf4c1e725-bcae-2255-e053-2995a90ad3352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-1467-7672961467071 TABLET in 1 BOTTLE (67296-1467-7) 1 tablet2018-08-31NoNoCurrent