FDA.reportPublic FDA data

Mucinex

Product NDC
63824-023
11-digit product format
638240023
Labeler code
63824
Product ID
63824-023_32471226-a16f-5531-e063-6394a90a382f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RB Health (US) LLC
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
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-023-02MucinexMaximum Strength1 in 1 POUCHTABLET, EXTENDED RELEASE116
63824-023-02MucinexMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE116
63824-023-07MucinexMaximum Strength7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE716
63824-023-07MucinexMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE116
63824-023-18MucinexMaximum Strength9 in 1 BLISTER PACKTABLET, EXTENDED RELEASE916
63824-023-18MucinexMaximum Strength2 in 1 CARTONTABLET, EXTENDED RELEASE216
63824-023-35MucinexMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE116
63824-023-35MucinexMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1416
63824-023-36MucinexMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1416
63824-023-36MucinexMaximum Strength2 in 1 CARTONTABLET, EXTENDED RELEASE216
63824-023-46MucinexMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1416
63824-023-46MucinexMaximum Strength3 in 1 CARTONTABLET, EXTENDED RELEASE316
63824-023-48MucinexMaximum Strength12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1216
63824-023-48MucinexMaximum Strength4 in 1 CARTONTABLET, EXTENDED RELEASE416
63824-023-56MucinexMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1416
63824-023-56MucinexMaximum Strength4 in 1 CARTONTABLET, EXTENDED RELEASE416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-023-07EA - Each63824-02328e1d815-0c0a-4cde-9c58-b42d4cdb454312015-08-04
63824-023-14EA - Each63824-0235af046a6-1ef9-47f6-aab2-b208dbe48d8112012-07-24
63824-023-18EA - Each63824-0232691f976-8dbf-49a3-9c7b-ffaa3032e55712021-04-08
63824-023-28EA - Each63824-0238242604c-2af8-4a05-8c12-b974f13005e212012-07-24
63824-023-35EA - Each63824-023e4523467-ea8f-4dc5-956d-3a56ebbc0c2c12012-07-24
63824-023-36EA - Each63824-02340a3b4a1-9bfd-45b8-b83f-cc94ecf90cd612012-07-24
63824-023-45EA - Each63824-023d8efef87-b4bb-428f-bd71-fc1420a7642112012-07-24
63824-023-46EA - Each63824-0231af51cca-a372-4b8d-85fe-3b9cfec229aa12012-07-24
63824-023-48EA - Each63824-023f05af7c9-7640-4e95-b5f6-e38325371d7b12012-07-24
63824-023-56EA - Each63824-023b072127b-4406-4ca4-8f88-ee712d35fcb512021-08-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQMUCINEX MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
aluminum oxideINACTIVE INGREDIENTLMI26O6933MUCINEX MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENTHHT01ZNK31MUCINEX MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMUCINEX MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDMUCINEX MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMUCINEX MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
magnesium stearateINACTIVE INGREDIENT70097M6I30MUCINEX MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-023MUCINEX MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [RB HEALTH (US) LLC]15Current NDC, Legacy NDC, 16 package rows20250410_47f5323c-ee3a-400d-b133-31d9c286fafd.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
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN47f5323c-ee3a-400d-b133-31d9c286fafd16
891297Mucinex 1200 MG 12HR Extended Release Oral TabletPSN47f5323c-ee3a-400d-b133-31d9c286fafd16
89129712 HR guaifenesin 1200 MG Extended Release Oral Tablet [Mucinex]SBD47f5323c-ee3a-400d-b133-31d9c286fafd16
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD47f5323c-ee3a-400d-b133-31d9c286fafd16
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY47f5323c-ee3a-400d-b133-31d9c286fafd16
891297Mucinex 1200 MG 12 HR Extended Release Oral TabletSY47f5323c-ee3a-400d-b133-31d9c286fafd16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-023-02638240023021 POUCH in 1 CARTON (63824-023-02) / 1 TABLET, EXTENDED RELEASE in 1 POUCH1 pouch2021-07-010000-00-00NoNoCurrent
63824-023-07638240023071 BLISTER PACK in 1 CARTON (63824-023-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2015-06-110000-00-00NoNoCurrent
63824-023-18638240023182 BLISTER PACK in 1 CARTON (63824-023-18) > 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2012-06-260000-00-00NoNoCurrent
63824-023-35638240023351 BLISTER PACK in 1 CARTON (63824-023-35) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2012-06-260000-00-00NoNoCurrent
63824-023-36638240023362 BLISTER PACK in 1 CARTON (63824-023-36) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2012-06-260000-00-00NoNoCurrent
63824-023-46638240023463 BLISTER PACK in 1 CARTON (63824-023-46) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2012-06-260000-00-00NoNoCurrent
63824-023-48638240023484 BLISTER PACK in 1 CARTON (63824-023-48) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2012-06-260000-00-00NoNoCurrent
63824-023-56638240023564 BLISTER PACK in 1 CARTON (63824-023-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2021-07-010000-00-00NoNoCurrent