Application 021585

Type
NDA
Sponsor
RB HLTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MUCINEX DGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL600MG;60MGYesNo
002MUCINEX DGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1.2GM;120MGYesYes

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
N021585-001MUCINEX DGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22
N021585-002MUCINEX DGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22

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 UTC2026-02N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22782e0a99824c…
2021-12-28 21:50 UTC2021-12N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22782e0a99824c…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021585-00163722522020-04-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021585-00169558212020-04-28U-686Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021585-00178380322020-04-28Drug product2010-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021585-00263722522020-04-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021585-00269558212020-04-28U-686Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021585-00278380322020-04-28Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021585-00163722522020-04-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021585-00169558212020-04-28U-686Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021585-00178380322020-04-28Drug product2010-12-218869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021585-00263722522020-04-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021585-00269558212020-04-28U-686Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021585-00278380322020-04-28Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021585-00163722522020-04-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021585-00169558212020-04-28U-686Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021585-00178380322020-04-28Drug product2010-12-21c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021585-00263722522020-04-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021585-00269558212020-04-28U-686Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021585-00278380322020-04-28Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021585-00163722522020-04-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021585-00169558212020-04-28U-686Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021585-00178380322020-04-28Drug product2010-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N021585-00263722522020-04-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021585-00269558212020-04-28U-686Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021585-00278380322020-04-28Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021585-00163722522020-04-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021585-00169558212020-04-28U-686Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021585-00178380322020-04-28Drug product2010-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N021585-00263722522020-04-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021585-00269558212020-04-28U-686Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021585-00278380322020-04-28Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021585-00163722522020-04-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021585-00169558212020-04-28U-686Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021585-00178380322020-04-28Drug product2010-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N021585-00263722522020-04-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021585-00269558212020-04-28U-686Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021585-00278380322020-04-28Drug productea99ee380514…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLCd5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f2026-05-27WarningsExact identifier
application applno (NDA): 021585
application number: NDA021585
ndc (product): 63824-057
Guaifenesin DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDERUGBY LABORATORIES, INC.997946e6-eff0-4c15-8694-020a19c2d3362026-05-06WarningsExact identifier
ndc (product): 0536-1333
Mucinex D Maximum StrengthGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLCd9264518-2f2c-498f-b733-6f3397336a012026-04-21WarningsExact identifier
application applno (NDA): 021585
application number: NDA021585
ndc (product): 63824-041
Mucinex DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions7f9cc03f-7cc9-4e3b-9ba9-a8d0103b98c92025-06-23WarningsExact identifier
application applno (NDA): 021585
application number: NDA021585
ndc (product): 50090-1075
MUCINEX DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutionsd47cdbbc-34ae-4177-a222-225e1d7efbed2024-01-11WarningsExact identifier
application applno (NDA): 021585
application number: NDA021585
ndc (product): 50090-1076
Guaifenesin DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Companyabecb791-b635-482f-bb99-3ee4b7093e782022-06-24WarningsExact identifier
ndc (product): 0363-9930
Guaifenesin and Pseudoephedrine HydrochlorideGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN COMPANY310d14be-e7ea-44b8-8b04-cffa39440d502018-10-27WarningsExact identifier
application applno (NDA): 021585
application number: NDA021585
ndc (product): 0363-0077

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0077Guaifenesin and Pseudoephedrine HydrochlorideGuaifenesin and Pseudoephedrine HydrochlorideWALGREEN COMPANYNDACurrent
0363-9930Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideWalgreen CompanyNDACurrent
0363-9930Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideWalgreen CompanyNDACurrent
0536-1137Mucus Relief DGuaifenesin and Pseudoephedrine HydrochlorideRugby LaboratoriesNDACurrent
0536-1333Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideRUGBY LABORATORIES, INC.NDACurrent
0536-1333Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideRUGBY LABORATORIES, INC.NDACurrent
50090-1075Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideA-S Medication SolutionsNDACurrent
50090-1075Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideA-S Medication SolutionsNDACurrent
50090-1076Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideA-S Medication SolutionsNDACurrent
50090-1076Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideA-S Medication SolutionsNDACurrent
51660-071Guaifenesin and Pseudoephedrine HydrochlorideGuaifenesin and Pseudoephedrine HydrochlorideOHM LABORATORIES INCNDACurrent
51660-071Guaifenesin and Pseudoephedrine HydrochlorideGuaifenesin and Pseudoephedrine HydrochlorideOHM LABORATORIES INCNDACurrent
63824-041Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideRB Health (US) LLCNDACurrent
63824-041Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideReckitt Benckiser LLCNDACurrent
63824-041Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideRB Health (US) LLCNDACurrent
63824-057Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideRB Health (US) LLCNDACurrent
63824-057Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideRB Health (US) LLCNDACurrent
63824-057Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideRB Health (US) LLCNDACurrent
68258-3035Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideDispensing Solutions Inc.NDACurrent
70000-0580Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideCARDINAL HEALTH 110, LLC. DBA LEADERNDACurrent
70000-0580Guaifenesin DGuaifenesin and Pseudoephedrine HydrochlorideCARDINAL HEALTH 110, LLC. DBA LEADERNDACurrent
70518-0523Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideREMEDYREPACK INC.NDACurrent
70518-0523Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideREMEDYREPACK INC.NDACurrent
70518-0523Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideREMEDYREPACK INC.NDACurrent
70518-0523Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideREMEDYREPACK INC.NDACurrent
70518-0523Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideREMEDYREPACK INC.NDACurrent
70518-0523Mucinex DGuaifenesin and Pseudoephedrine HydrochlorideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78999SUPPL 2024-07-09
78998SUPPL 2024-07-09
60166SUPPL2019-10-01
50586SUPPL2017-12-04
50583SUPPL2017-12-01
28181SUPPL2014-03-07
28180SUPPL2010-12-22
37277SUPPL2007-09-07
28179SUPPL2007-09-07
21744ORIG2005-12-01
28178SUPPL2005-03-03
5783SUPPL2005-01-26
37276ORIG2004-06-25
28177ORIG2004-06-25