FDA.reportPublic FDA data

Mucus Relief Extended-Release

Product NDC
11673-731
11-digit product format
116730731
Labeler code
11673
Product ID
11673-731_b1c80af5-0e18-4d85-bf7d-1933a1a03cc3
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
TARGET Corporation
Application
ANDA207342
Marketing category
ANDA
Marketing start
2018-07-11
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
11673-731-20Mucus Relief Extended-Release1 in 1 BLISTER PACKTABLET14
11673-731-20Mucus Relief Extended-Release20 in 1 CARTONTABLET204
11673-731-40Mucus Relief Extended-Release1 in 1 BLISTER PACKTABLET14
11673-731-40Mucus Relief Extended-Release40 in 1 CARTONTABLET404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-731MUCUS RELIEF EXTENDED-RELEASE (GUAIFENESIN) TABLET [TARGET CORPORATION]4Current NDC, Legacy NDC, 4 package rows20221118_e374e8de-1eff-4f70-8e01-08e0f56b9789.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNe374e8de-1eff-4f70-8e01-08e0f56b97894
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDe374e8de-1eff-4f70-8e01-08e0f56b97894
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYe374e8de-1eff-4f70-8e01-08e0f56b97894

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-731-201167307312020 BLISTER PACK in 1 CARTON (11673-731-20) / 1 TABLET in 1 BLISTER PACK20 blister pack2018-07-110000-00-00NoNoCurrent
11673-731-401167307314040 BLISTER PACK in 1 CARTON (11673-731-40) / 1 TABLET in 1 BLISTER PACK40 blister pack2018-07-110000-00-00NoNoCurrent