FDA.reportPublic FDA data

Mucinex

Product NDC
68084-572
11-digit product format
680840572
Labeler code
68084
Product ID
68084-572_1e137707-60f2-51ee-e063-6294a90afe82
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
NDA021282
Marketing category
NDA
Marketing start
2016-02-19
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
68084-572-01Mucinex100 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE1006
68084-572-11Mucinex1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-572-01EA - Each68084-5727ab5ca81-29b5-43c8-a1b2-e6ed1e77d9ff12016-03-04
68084-572-11EA - Each68084-57273ac4d98-13e7-4316-8be8-723d375ed07b12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-572MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20240726_0129f47d-abc2-414c-b4e1-1064c5d6a623.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN8b0d6d01-f1dd-41b0-a71e-46668bc9cde68
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSN8b0d6d01-f1dd-41b0-a71e-46668bc9cde68
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBD8b0d6d01-f1dd-41b0-a71e-46668bc9cde68
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD8b0d6d01-f1dd-41b0-a71e-46668bc9cde68
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY8b0d6d01-f1dd-41b0-a71e-46668bc9cde68
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSY8b0d6d01-f1dd-41b0-a71e-46668bc9cde68
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN0129f47d-abc2-414c-b4e1-1064c5d6a6236
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSN0129f47d-abc2-414c-b4e1-1064c5d6a6236
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBD0129f47d-abc2-414c-b4e1-1064c5d6a6236
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD0129f47d-abc2-414c-b4e1-1064c5d6a6236
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY0129f47d-abc2-414c-b4e1-1064c5d6a6236
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSY0129f47d-abc2-414c-b4e1-1064c5d6a6236

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-572-0168084057201100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-572-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-572-11) 100 blister pack2016-02-190000-00-00NoNoCurrent
68084-572-11680840572111 in 1 BLISTER PACKHistorical