FDA.reportPublic FDA data

Mucinex

Product NDC
50090-1340
11-digit product format
500901340
Labeler code
50090
Product ID
50090-1340_343e9af3-cc85-4467-b51e-fcc00daf2759
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021282
Marketing category
NDA
Marketing start
2012-07-03
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
Mucinex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522, 891301

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
50090-1340-0Mucinex1 in 1 CARTONTABLET, EXTENDED RELEASE113
50090-1340-0Mucinex20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE2013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1340-0EA - Each50090-13406cb9fb07-439e-4d23-a3bc-32adc79062dd12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1340MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20231210_92a70574-c373-4261-b20d-8ea8ef677bcf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN92a70574-c373-4261-b20d-8ea8ef677bcf13
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSN92a70574-c373-4261-b20d-8ea8ef677bcf13
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBD92a70574-c373-4261-b20d-8ea8ef677bcf13
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD92a70574-c373-4261-b20d-8ea8ef677bcf13
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY92a70574-c373-4261-b20d-8ea8ef677bcf13
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSY92a70574-c373-4261-b20d-8ea8ef677bcf13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1340-0500901340001 BLISTER PACK in 1 CARTON (50090-1340-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2014-11-280000-00-00NoNoCurrent