Mucinex

Product NDC
67296-0569
Requested package NDC
67296-0569-7
11-digit product format
672960569
Labeler code
67296
Product ID
67296-0569_bdae80ef-3eac-7455-e053-2a95a90a410c
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
NDA021282
Marketing category
NDA
Marketing start
2012-07-03
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
600 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage67296-056967296-0569-7IInactivated by FDA2026-08-11

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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…

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, Related label table
NDCEffectiveRelated label
67296-0569-12026-01-29Mucinex 600mg tablets
67296-0569-72026-01-29Mucinex 600mg tablets
67296-0569-72024-07-19Mucinex 600mg tablets
67296-0569-72023-01-30Mucinex 600mg tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0569-1Mucinex20 in 1 BOTTLETABLET, EXTENDED RELEASE203
67296-0569-7Mucinex14 in 1 BOTTLETABLET, EXTENDED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0569MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [REDPHARM DRUG, INC.]3Legacy NDC, 2 package rows20240823_bdae8726-ff98-4866-e053-2995a90ad67a.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
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
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNbdae8726-ff98-4866-e053-2995a90ad67a3
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSNbdae8726-ff98-4866-e053-2995a90ad67a3
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBDbdae8726-ff98-4866-e053-2995a90ad67a3
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDbdae8726-ff98-4866-e053-2995a90ad67a3
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYbdae8726-ff98-4866-e053-2995a90ad67a3
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSYbdae8726-ff98-4866-e053-2995a90ad67a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-0569-76729605690714 TABLET, EXTENDED RELEASE in 1 BOTTLE (67296-0569-7) 2012-07-030000-00-00NoNoCurrent