FDA.reportPublic FDA data

Mucinex

Product NDC
50090-2301
11-digit product format
500902301
Labeler code
50090
Product ID
50090-2301_30356fcf-98ca-4679-9c38-90864862a276
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
2012-06-26
Substance
GUAIFENESIN
Active strength
1200 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
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621, 891297

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
50090-2301-02023-02-06C16284748780-1f386c649-eea7-0266-e053-dadaa90a7c1aMUCINEX MAXIMUM STRENGTH
50090-2301-02023-01-30C16284748780-1f386c649-eea7-0266-e053-dadaa90a7c1aMUCINEX MAXIMUM STRENGTH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2301-0MucinexMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE117
50090-2301-0MucinexMaximum Strength7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE717
50090-2301-1MucinexMaximum Strength2 in 1 CARTONTABLET, EXTENDED RELEASE217
50090-2301-1MucinexMaximum Strength7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2301-0EA - Each50090-2301c22da608-cd69-4237-961a-e2dd51db521412018-11-06
50090-2301-1EA - Each50090-230114b7662d-abc9-4b28-8fad-89170611143512025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2301MUCINEX MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 4 package rows20231207_7e09314c-3421-4053-a2ac-b67bf5610f83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN7e09314c-3421-4053-a2ac-b67bf5610f8317
891297Mucinex 1200 MG 12HR Extended Release Oral TabletPSN7e09314c-3421-4053-a2ac-b67bf5610f8317
89129712 HR guaifenesin 1200 MG Extended Release Oral Tablet [Mucinex]SBD7e09314c-3421-4053-a2ac-b67bf5610f8317
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD7e09314c-3421-4053-a2ac-b67bf5610f8317
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY7e09314c-3421-4053-a2ac-b67bf5610f8317
891297Mucinex 1200 MG 12 HR Extended Release Oral TabletSY7e09314c-3421-4053-a2ac-b67bf5610f8317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2301-0500902301001 BLISTER PACK in 1 CARTON (50090-2301-0) > 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2016-02-110000-00-00NoNoCurrent
50090-2301-1500902301012 BLISTER PACK in 1 CARTON (50090-2301-1) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2025-06-05NoNoCurrent