FDA.reportPublic FDA data

MUCINEX

Product NDC
50090-6078
11-digit product format
500906078
Labeler code
50090
Product ID
50090-6078_049a1f87-10ee-4c8a-858b-218611764bff
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
50090-6078-0MUCINEX480 in 1 CASETABLET, EXTENDED RELEASE4802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6078-0EA - Each50090-6078e60e9148-32d1-4da1-bf35-0b2f0f99ad2012025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6078MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]2Current NDC, 1 package rows20240530_69c83a02-377f-4c6c-96f6-557b3a3d8ca1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN69c83a02-377f-4c6c-96f6-557b3a3d8ca12
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSN69c83a02-377f-4c6c-96f6-557b3a3d8ca12
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBD69c83a02-377f-4c6c-96f6-557b3a3d8ca12
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD69c83a02-377f-4c6c-96f6-557b3a3d8ca12
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY69c83a02-377f-4c6c-96f6-557b3a3d8ca12
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSY69c83a02-377f-4c6c-96f6-557b3a3d8ca12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6078-050090607800480 TABLET, EXTENDED RELEASE in 1 CASE (50090-6078-0) 2022-09-16NoNoHistorical