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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63824-02363824-023-18DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021282-001MUCINEXGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12
N021282-002MUCINEXGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12a50c72e98297…
2026-08-01 22:54:322026-06N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MucinexGUAIFENESINBryant Ranch Prepacka898b584-e17e-45c4-8a28-9f686b95dca02026-06-29WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
MucinexGUAIFENESINBryant Ranch Prepacka8c67e0a-1f2c-4e96-91fe-0d90546d8b1b2026-06-29WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
Mucinex Maximum StrengthGUAIFENESINReckitt Benckiser LLC47f5323c-ee3a-400d-b133-31d9c286fafd2026-05-27WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
ndc (product): 63824-023
MucinexGUAIFENESINReckitt Benckiser LLCdd379cdd-90ab-42e0-ad89-f50d3220f6112026-05-27WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
MucinexGUAIFENESINCardinal Health 107, LLC8b0d6d01-f1dd-41b0-a71e-46668bc9cde62026-05-12WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
MucinexGUAIFENESINATLANTIC BIOLOGICAS CORP.40c67cca-f202-4652-9507-2442d26cfd672025-12-04WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
Mucinex Maximum StrengthGUAIFENESINA-S Medication Solutions7e09314c-3421-4053-a2ac-b67bf5610f832025-06-09WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
MucinexGUAIFENESINAmerican Health Packaging0129f47d-abc2-414c-b4e1-1064c5d6a6232024-07-25WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
MUCINEXGUAIFENESINA-S Medication Solutions69c83a02-377f-4c6c-96f6-557b3a3d8ca12024-05-29WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
MucinexGUAIFENESINA-S Medication Solutions37a1c123-d623-40d0-a7fb-d4f7d126b3402024-01-05WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
MucinexGUAIFENESINA-S Medication Solutions92a70574-c373-4261-b20d-8ea8ef677bcf2023-12-09WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
MUCINEXGUAIFENESINA-S Medication Solutions08ea92cc-4a0f-44c9-9edf-71f67e0144312023-10-23WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
MucinexGUAIFENESINProficient Rx LPf3ade814-2759-4ad0-a196-210e84d8cde92021-01-01WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282
MucinexGUAIFENESINAphena Pharma Solutions - Tennessee, LLC1c84bf00-ebaa-4e69-a2c6-716631d209d92017-12-18WarningsExact identifier
application applno (NDA): 021282
application number: NDA021282

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310621Internal RxNorm lookup
891297Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
47f5323c-ee3a-400d-b133-31d9c286fafdAvailable on FDA.report

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