FDA.reportPublic FDA data

MUCINEX

Product NDC
50090-2380
11-digit product format
500902380
Labeler code
50090
Product ID
50090-2380_e23e23cc-0b6c-46ff-ac29-7d0e25443967
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2380-02023-02-06C16284748780-1f386c649-d367-0266-e053-dadaa90a7c1aMUCINEX
50090-2380-02023-01-30C16284748780-1f386c649-d367-0266-e053-dadaa90a7c1aMUCINEX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2380-0MUCINEX28 in 1 BOTTLETABLET, EXTENDED RELEASE2816

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2380-0EA - Each50090-23805dcb1d09-5f9f-4a02-b976-f0cebcbb1d0c12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2380MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 1 package rows20231024_08ea92cc-4a0f-44c9-9edf-71f67e014431.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN08ea92cc-4a0f-44c9-9edf-71f67e01443116
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSN08ea92cc-4a0f-44c9-9edf-71f67e01443116
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBD08ea92cc-4a0f-44c9-9edf-71f67e01443116
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD08ea92cc-4a0f-44c9-9edf-71f67e01443116
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY08ea92cc-4a0f-44c9-9edf-71f67e01443116
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSY08ea92cc-4a0f-44c9-9edf-71f67e01443116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2380-05009023800028 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-2380-0) 2016-04-270000-00-00NoNoCurrent