Mucinex

Product NDC
63629-7115
11-digit product format
636297115
Labeler code
63629
Product ID
63629-7115_9889ac23-e24f-4e1f-a23c-488b2f304e0e
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
63629-7115-12024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-22024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-32024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-42024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-52024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-12024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-22024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-32024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-42024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-52024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-12020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-22020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-32020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-42020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-52020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-12020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-22020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-32020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-42020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-52020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7115-1Mucinex30 in 1 BOTTLETABLET, EXTENDED RELEASE3011
63629-7115-2Mucinex20 in 1 BOTTLETABLET, EXTENDED RELEASE2011
63629-7115-3Mucinex60 in 1 BOTTLETABLET, EXTENDED RELEASE6011
63629-7115-4Mucinex40 in 1 BOTTLETABLET, EXTENDED RELEASE4011
63629-7115-5Mucinex14 in 1 BOTTLETABLET, EXTENDED RELEASE1411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7115MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 5 package rows20240518_a898b584-e17e-45c4-8a28-9f686b95dca0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNa898b584-e17e-45c4-8a28-9f686b95dca011
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSNa898b584-e17e-45c4-8a28-9f686b95dca011
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBDa898b584-e17e-45c4-8a28-9f686b95dca011
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDa898b584-e17e-45c4-8a28-9f686b95dca011
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYa898b584-e17e-45c4-8a28-9f686b95dca011
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSYa898b584-e17e-45c4-8a28-9f686b95dca011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7115-16362971150130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-1) 2024-04-020000-00-00NoNoCurrent
63629-7115-26362971150220 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-2) 2016-10-170000-00-00NoNoCurrent
63629-7115-36362971150360 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-3) 2024-04-020000-00-00NoNoCurrent
63629-7115-46362971150440 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-4) 2019-02-040000-00-00NoNoCurrent
63629-7115-56362971150514 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7115-5) 2024-04-020000-00-00NoNoCurrent