FDA.reportPublic FDA data

Mucus Relief Extended Release

Product NDC
11673-732
11-digit product format
116730732
Labeler code
11673
Product ID
11673-732_0624fe9f-c5f8-4fd0-becf-0efde9821b5f
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
1200 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
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-732-14Mucus Relief Extended Release1 in 1 BLISTER PACKTABLET13
11673-732-14Mucus Relief Extended Release14 in 1 CARTONTABLET143
11673-732-28Mucus Relief Extended Release1 in 1 BLISTER PACKTABLET13
11673-732-28Mucus Relief Extended Release28 in 1 CARTONTABLET283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-732MUCUS RELIEF EXTENDED RELEASE (GUAIFENESIN) TABLET [TARGET CORPORATION]3Current NDC, Legacy NDC, 4 package rows20221118_e521e8e1-8227-451a-8858-01c26f6e0657.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNe521e8e1-8227-451a-8858-01c26f6e06573
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDe521e8e1-8227-451a-8858-01c26f6e06573
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYe521e8e1-8227-451a-8858-01c26f6e06573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-732-141167307321414 BLISTER PACK in 1 CARTON (11673-732-14) / 1 TABLET in 1 BLISTER PACK14 blister pack2018-07-110000-00-00NoNoCurrent
11673-732-281167307322828 BLISTER PACK in 1 CARTON (11673-732-28) / 1 TABLET in 1 BLISTER PACK28 blister pack2018-07-110000-00-00NoNoCurrent