FDA.reportPublic FDA data

Mucinex

Product NDC
17856-0008
11-digit product format
178560008
Labeler code
17856
Product ID
17856-0008_45244b74-1b9b-2f5d-e063-6394a90a1002
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
ATLANTIC BIOLOGICAS CORP.
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
17856-0008-22024-06-05C16284748780-1f386c64a-1ccb-0266-e053-dadaa90a7c1aMucinex ®
17856-0008-22023-01-30C16284748780-1f386c64a-1ccb-0266-e053-dadaa90a7c1aMucinex ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0008-2Mucinex1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0008-2EA - Each17856-0008891a875e-963b-4c51-822a-ce1dce4bc40712025-06-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]3
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]3
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK31MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0008MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [ATLANTIC BIOLOGICAS CORP.]7Current NDC, Legacy NDC, 1 package rows20240606_40c67cca-f202-4652-9507-2442d26cfd67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN40c67cca-f202-4652-9507-2442d26cfd679
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSN40c67cca-f202-4652-9507-2442d26cfd679
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBD40c67cca-f202-4652-9507-2442d26cfd679
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD40c67cca-f202-4652-9507-2442d26cfd679
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY40c67cca-f202-4652-9507-2442d26cfd679
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSY40c67cca-f202-4652-9507-2442d26cfd679

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0008-2178560008021 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (17856-0008-2) 2024-06-050000-00-00NoNoCurrent