FDA.reportPublic FDA data

Application 207342

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL600MGNoNo
002GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL1.2GMNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207342-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11
A207342-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1184e616aacf4f…
2026-09-14 22:38:342026-08A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1184e616aacf4f…
2026-08-18 06:07:402026-07A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1174a2ff9319b5…

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCcd7955b2-8eee-43d3-973f-6de2f39295122026-09-09WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINP & L Development, LLC3c01a88f-35c8-4e43-9997-ebee7943820f2026-08-10WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Extended Release Maximum StrengthGUAIFENESINCVS Pharmacy34314503-b253-4b44-96ff-a42fe2bb161f2026-07-22WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
ndc (product): 69842-732
Mucus Relief ERGUAIFENESINCardinal Health 107, LLCf7abc2ff-21bc-48b5-9989-c5ac84f5c9cd2026-07-21WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINRugby Laboratoriesee413595-2687-4c38-84ce-18aac933d8e32026-07-15WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Extended ReleaseGUAIFENESINTARGET Corporatione521e8e1-8227-451a-8858-01c26f6e06572026-07-06WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINHarris Teeter, LLCf7f2e64c-0fb9-413d-80ed-4d7cc2a07e0c2026-05-01WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINBest Choice (Valu Merchandisers Company)9bac4bbb-a20c-48c5-891b-63f14a664d042026-04-15WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
ndc (product): 63941-731
Mucus Relief Extended Release Maximum StrengthGUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADER 7000054a59e95-f95a-4bcd-ac9d-8d4ace85277f2026-02-10WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
ndc (product): 70000-0479
Mucus ReliefGUAIFENESINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)32f58b4a-3e1b-424f-8296-a9bf9a7d70252025-11-11WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINFamily Dollar (FAMILY WELLNESS)1e1a9335-58ac-4722-9188-c847e62e72152025-11-05WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINFamily Dollar (FAMILY WELLNESS)ddc18f31-acb2-4305-929a-f4746efd42242025-10-24WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Extended Release Maximum StrengthGUAIFENESINWalgreense4b27b9b-5f3b-4314-9717-54d73cf6b74e2025-08-28WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINRite Aid Corporation73fb2194-a582-4d3c-bc82-c5f110efcd812025-08-20WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Extended ReleaseGUAIFENESINRugby Laboratories, Inc.8bc6f08e-a941-4fa8-8dd6-a699abf2337d2025-04-21WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINH E Befebda97-5234-451c-a854-91a32303a6b72025-03-17WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief ERGUAIFENESINMajor Pharmaceuticalse5a242bf-3008-4c92-a930-e76f733be5cf2025-03-07WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINP & L Development, LLCa2d14780-4a69-496e-86fe-7f2443cb0f202025-02-12WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Extended ReleaseGUAIFENESINRedpharm Drug Inc.f4c1e725-bcae-2255-e053-2995a90ad3352025-01-23WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
GuaifenesinGUAIFENESINAmneal Pharmaceuticals LLCad67e6fd-a68f-44db-9718-84a2cef86e092024-10-07WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
ndc (product): 65162-037
ndc (product): 65162-036

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 125 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62011-0377Mucus Relief Extended ReleaseGuaifenesinStrategic Sourcing Services LLCANDACurrent
62011-0377Mucus Relief Extended ReleaseGuaifenesinMcKesson (Health Mart)ANDACurrent
62011-0378Mucus Relief Extended ReleaseGuaifenesinMcKesson (Health Mart)ANDACurrent
62011-0378Mucus Relief Extended ReleaseGuaifenesinStrategic Sourcing Services LLCANDACurrent
62011-0378Mucus Relief Extended ReleaseGuaifenesinMcKesson (Health Mart)ANDACurrent
62011-0378Mucus Relief Extended ReleaseGuaifenesinStrategic Sourcing Services LLCANDACurrent
63868-871Mucus Relief Extended ReleaseGuaifenesinQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-871Mucus Relief Extended ReleaseGuaifenesinQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-872Mucus Relief Extended ReleaseGuaifenesinQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-872Mucus Relief Extended ReleaseGuaifenesinQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63941-731Mucus ReliefGuaifenesinBest Choice (Valu Merchandisers Company)ANDACurrent
65162-036GuaifenesinGuaifenesinAmneal Pharmaceuticals LLCANDACurrent
65162-036GuaifenesinGuaifenesinAmneal Pharmaceuticals LLCANDACurrent
65162-036GuaifenesinGuaifenesinAmneal Pharmaceuticals LLCANDACurrent
65162-036GuaifenesinGuaifenesinAmneal Pharmaceuticals LLCANDACurrent
65162-037GuaifenesinGuaifenesinAmneal Pharmaceuticals LLCANDACurrent
65162-037GuaifenesinGuaifenesinAmneal Pharmaceuticals LLCANDACurrent
65162-037GuaifenesinGuaifenesinAmneal Pharmaceuticals LLCANDACurrent
65162-037GuaifenesinGuaifenesinAmneal Pharmaceuticals LLCANDACurrent
67091-370Mucus ReliefGuaifenesinWinCo Foods, LLCANDACurrent
67091-370Mucus ReliefGuaifenesinWinCo Foods, LLCANDACurrent
68016-170Mucus ReliefGuaifenesinChain Drug Consortium, LLCANDACurrent
68016-170Mucus ReliefGuaifenesinChain Drug Consortium, LLCANDACurrent
68016-170Mucus ReliefGuaifenesinChain Drug Consortium, LLCANDACurrent
69256-732Mucus Relief Extended ReleaseGuaifenesinHarris Teeter, LLCANDACurrent
69256-732Mucus Relief Extended ReleaseGuaifenesinHarris Teeter, LLCANDACurrent
69842-732Mucus Relief Extended ReleaseGuaifenesinCVS PharmacyANDACurrent
69842-732Mucus Relief Extended ReleaseGuaifenesinCVS PharmacyANDACurrent
69842-732Mucus Relief Extended ReleaseGuaifenesinCVS PharmacyANDACurrent
69842-732Mucus Relief Extended ReleaseGuaifenesinCVS PharmacyANDACurrent
70000-0479Mucus Relief Extended ReleaseGuaifenesinCardinal Health (Leader) 70000ANDACurrent
70000-0479Mucus Relief Extended ReleaseGuaifenesinCardinal Health (Leader) 70000ANDACurrent
70000-0479Mucus Relief Extended ReleaseGuaifenesinCardinal Health (Leader) 70000ANDACurrent
70000-0479Mucus Relief Extended ReleaseGuaifenesinCardinal Health (Leader) 70000ANDACurrent
70000-0479Mucus Relief Extended ReleaseGuaifenesinCardinal Health (Leader) 70000ANDACurrent
70677-0049Mucus ReliefGuaifenesinStrategic Sourcing Services LLCANDACurrent
70677-0049Mucus ReliefGuaifenesinStrategic Sourcing Services LLCANDACurrent
70677-0049Mucus ReliefGuaifenesinMcKesson (Sunmark)ANDACurrent
70677-0049Mucus ReliefGuaifenesinStrategic Sourcing Services LLCANDACurrent
70677-0050Mucus Relief Extended-ReleaseGuaifenesinStrategic Sourcing Services LLCANDACurrent
70677-0050Mucus Relief Extended-ReleaseGuaifenesinStrategic Sourcing Services LLCANDACurrent
70677-0050Mucus Relief Extended-ReleaseGuaifenesinMcKesson (Sunmark)ANDACurrent
70677-0050Mucus Relief Extended-ReleaseGuaifenesinMcKesson (Sunmark)ANDACurrent
70677-0050Mucus Relief Extended-ReleaseGuaifenesinStrategic Sourcing Services LLCANDACurrent
82649-732Mucus ReliefGuaifenesinLifeMDANDACurrent