FDA.reportPublic FDA data

up and up mucus relief

Product NDC
11673-421
11-digit product format
116730421
Labeler code
11673
Product ID
11673-421_071469f4-4417-4729-8e75-1536c4dc422f
Type
HUMAN OTC DRUG
Nonproprietary name
guaifenesin
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Labeler
Target Corporation
Application
ANDA078912
Marketing category
ANDA
Marketing start
2020-07-31
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
up and up mucus relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

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
11673-421-01up and up mucus relief1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL15
11673-421-01up and up mucus relief20 in 1 BLISTER PACKTABLET, MULTILAYER, EXTENDED REL205
11673-421-60up and up mucus relief1 in 1 CARTONTABLET, MULTILAYER, EXTENDED REL15
11673-421-60up and up mucus relief20 in 1 BOTTLETABLET, MULTILAYER, EXTENDED REL205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-421UP AND UP MUCUS RELIEF (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [TARGET CORPORATION]3Current NDC, Legacy NDC, 4 package rows20220601_7c1598f1-1236-48d2-861b-de4715e3f3d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN7c1598f1-1236-48d2-861b-de4715e3f3d25
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD7c1598f1-1236-48d2-861b-de4715e3f3d25
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY7c1598f1-1236-48d2-861b-de4715e3f3d25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-421-01116730421011 BLISTER PACK in 1 CARTON (11673-421-01) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2025-09-17NoNoHistorical
11673-421-60116730421601 BOTTLE in 1 CARTON (11673-421-60) > 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE1 bottle2020-07-310000-00-00NoNoCurrent