FDA.reportPublic FDA data

Mucinex

Product NDC
50090-0818
11-digit product format
500900818
Labeler code
50090
Product ID
50090-0818_f8c21bf6-1651-45af-ae1b-2a2ee595a122
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
50090-0818-02023-02-07C16284748780-1f386c649-da1b-0266-e053-dadaa90a7c1aMucinex ®
50090-0818-02023-01-30C16284748780-1f386c649-da1b-0266-e053-dadaa90a7c1aMucinex ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0818-0Mucinex20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE2023
50090-0818-0Mucinex2 in 1 CARTONTABLET, EXTENDED RELEASE223

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0818-0EA - Each50090-0818169fec70-f00e-42b8-9046-4a802ee4f66f12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0818MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]23Current NDC, Legacy NDC, 2 package rows20240106_37a1c123-d623-40d0-a7fb-d4f7d126b340.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN37a1c123-d623-40d0-a7fb-d4f7d126b34023
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSN37a1c123-d623-40d0-a7fb-d4f7d126b34023
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBD37a1c123-d623-40d0-a7fb-d4f7d126b34023
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD37a1c123-d623-40d0-a7fb-d4f7d126b34023
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY37a1c123-d623-40d0-a7fb-d4f7d126b34023
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSY37a1c123-d623-40d0-a7fb-d4f7d126b34023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0818-0500900818002 BLISTER PACK in 1 CARTON (50090-0818-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2014-11-280000-00-00NoNoCurrent