FDA.reportPublic FDA data

Mucinex

Product NDC
63629-7886
11-digit product format
636297886
Labeler code
63629
Product ID
63629-7886_e3e1bf91-e241-4351-9a79-8eb96e2e4326
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
63629-7886-12024-05-15C16284748780-11030e365-3cf3-111a-e063-dadaa90a10e2Mucinex ®
63629-7886-22024-05-15C16284748780-11030e365-3cf3-111a-e063-dadaa90a10e2Mucinex ®
63629-7886-12024-01-30C16284748780-11030e365-3cf3-111a-e063-dadaa90a10e2Mucinex ®
63629-7886-22024-01-30C16284748780-11030e365-3cf3-111a-e063-dadaa90a10e2Mucinex ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7886-1Mucinex20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE207
63629-7886-2Mucinex40 in 1 BLISTER PACKTABLET, EXTENDED RELEASE407

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7886MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 2 package rows20240517_a8c67e0a-1f2c-4e96-91fe-0d90546d8b1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNa8c67e0a-1f2c-4e96-91fe-0d90546d8b1b7
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSNa8c67e0a-1f2c-4e96-91fe-0d90546d8b1b7
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBDa8c67e0a-1f2c-4e96-91fe-0d90546d8b1b7
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDa8c67e0a-1f2c-4e96-91fe-0d90546d8b1b7
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYa8c67e0a-1f2c-4e96-91fe-0d90546d8b1b7
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSYa8c67e0a-1f2c-4e96-91fe-0d90546d8b1b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7886-16362978860120 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (63629-7886-1) 2019-06-130000-00-00NoNoCurrent
63629-7886-26362978860240 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (63629-7886-2) 2024-04-030000-00-00NoNoCurrent