Mucinex

Product NDC
50090-2301
Requested package NDC
50090-2301-0
11-digit product format
500902301
Labeler code
50090
Product ID
50090-2301_30356fcf-98ca-4679-9c38-90864862a276
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-230150090-2301-0DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-230150090-2301-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-230150090-2301-0DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18782e0a99824c…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021282-00163722522020-04-28U-48974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00169558212020-04-28U-489Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00178380322020-04-28Drug product2010-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00263722522020-04-28U-48974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00269558212020-04-28U-489Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00278380322020-04-28Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021282-00163722522020-04-28U-4898869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00169558212020-04-28U-489Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00178380322020-04-28Drug product2010-12-218869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00263722522020-04-28U-4898869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00269558212020-04-28U-489Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00278380322020-04-28Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021282-00163722522020-04-28U-489c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00169558212020-04-28U-489Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00178380322020-04-28Drug product2010-12-21c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00263722522020-04-28U-489c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00269558212020-04-28U-489Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00278380322020-04-28Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021282-00163722522020-04-28U-4893f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00169558212020-04-28U-489Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00178380322020-04-28Drug product2010-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00263722522020-04-28U-4893f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00269558212020-04-28U-489Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00278380322020-04-28Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021282-00163722522020-04-28U-489b00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00169558212020-04-28U-489Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00178380322020-04-28Drug product2010-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00263722522020-04-28U-489b00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00269558212020-04-28U-489Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00278380322020-04-28Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021282-00163722522020-04-28U-489ea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00169558212020-04-28U-489Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00178380322020-04-28Drug product2010-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00263722522020-04-28U-489ea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00269558212020-04-28U-489Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00278380322020-04-28Drug productea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Mucinex
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

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
7e09314c-3421-4053-a2ac-b67bf5610f83Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2301-02023-02-06C16284748780-1f386c649-eea7-0266-e053-dadaa90a7c1aMUCINEX MAXIMUM STRENGTH
50090-2301-02023-01-30C16284748780-1f386c649-eea7-0266-e053-dadaa90a7c1aMUCINEX MAXIMUM STRENGTH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2301-0MucinexMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE117
50090-2301-0MucinexMaximum Strength7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE717
50090-2301-1MucinexMaximum Strength2 in 1 CARTONTABLET, EXTENDED RELEASE217
50090-2301-1MucinexMaximum Strength7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2301-0EA - Each50090-2301c22da608-cd69-4237-961a-e2dd51db521412018-11-06
50090-2301-1EA - Each50090-230114b7662d-abc9-4b28-8fad-89170611143512025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2301MUCINEX MAXIMUM STRENGTH (GUAIFENESIN) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 4 package rows20231207_7e09314c-3421-4053-a2ac-b67bf5610f83.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
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
ndc (package): 50090-2301-0
ndc (product): 50090-2301
ndc11 (package): 50090230100
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2301-0500902301001 BLISTER PACK in 1 CARTON (50090-2301-0) > 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2016-02-110000-00-00NoNoCurrent