FDA.reportPublic FDA data

Application 091009

Type
ANDA
Sponsor
ACTAVIS LABS FL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091009-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-0384e616aacf4f…
2026-08-18 06:07:402026-07A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-033f01610625f2…
2019-09-15 20:21 UTC2019-09A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03f41ea6bd6efb…

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 3 of 14 · 279 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MucinexGUAIFENESINCardinal Health 107, LLC8b0d6d01-f1dd-41b0-a71e-46668bc9cde62026-05-12WarningsName fallback
generic name: GUAIFENESIN
Rugby Mucus and Chest Congestion 541GUAIFENESINRugby Laboratories76472912-b66f-4bb4-937a-4a589683a78c2026-05-04WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINHarris Teeter, LLCf7f2e64c-0fb9-413d-80ed-4d7cc2a07e0c2026-05-01WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINCVS Pharmacy2cfbb804-de2b-5b2f-e063-6394a90a08242026-04-28WarningsName fallback
generic name: GUAIFENESIN
GuaifenesinGUAIFENESINTOPCO ASSOCIATES LLC3a6e96d3-ac86-f388-e063-6394a90ade2d2026-04-23WarningsName fallback
brand name: Guaifenesin
generic name: GUAIFENESIN
good sense mucus erGUAIFENESINRedpharm Drug4fb57f87-f761-b52e-e063-6294a90ae4ee2026-04-18WarningsName fallback
generic name: GUAIFENESIN
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack9ed5611f-4e1d-4f71-b430-a2a949bf7fe52026-04-17WarningsName fallback
generic name: GUAIFENESIN
MUCUS RELIEFGUAIFENESINBryant Ranch Prepack761825bc-f835-4947-bfa0-2940f1dff5fb2026-04-17WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINWalgreen Company1cd69ede-29c6-4216-95b7-b58fc96c084b2026-04-16WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINBest Choice (Valu Merchandisers Company)9bac4bbb-a20c-48c5-891b-63f14a664d042026-04-15WarningsName fallback
generic name: GUAIFENESIN
GuaifenesinGUAIFENESINVESPYR BRANDS LLCe2e3c628-d241-42b6-8c1e-ef997ffa6e872026-04-13WarningsName fallback
brand name: Guaifenesin
generic name: GUAIFENESIN
Dr. Simi Mucus ReliefGUAIFENESINFarmacias De Similares TX LLC4ef7dae3-9081-bc3b-e063-6294a90a9a752026-04-08WarningsName fallback
generic name: GUAIFENESIN
Leader Mucus ReliefGUAIFENESINCardinal Health 110, LLC. dba Leaderca735722-0baa-4c85-8311-17dbce915fc52026-04-08WarningsName fallback
generic name: GUAIFENESIN
Good Neighbor Pharmacy Mucus ReliefGUAIFENESINAmerisourceBergen Drug Corp200dddd9-e3ff-4cec-a164-d1c9a698f1212026-03-31WarningsName fallback
generic name: GUAIFENESIN
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mgGUAIFENESINTWIN MED LLCd9d13c67-51a1-aa79-e053-2995a90abdbb2026-03-26WarningsName fallback
generic name: GUAIFENESIN
mucus erGUAIFENESINHyVee Inc851f49b5-34a0-4c58-90fa-51e265c7f7312026-03-26WarningsName fallback
generic name: GUAIFENESIN
GuaifenesinGUAIFENESINBryant Ranch Prepack1e9887f6-209f-4f1f-9afa-a5ca649721cb2026-03-18WarningsName fallback
brand name: Guaifenesin
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINGrocery Outlet, Inc.4466623c-6387-e725-e063-6394a90ad95e2026-03-14WarningsName fallback
generic name: GUAIFENESIN
good neighbor pharmacy mucus erGUAIFENESINAmerisource Bergen41b4a15d-f5a7-4c45-b950-0aa6b093be1c2026-03-12WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINAmerisource Bergen087a3a0b-8d3f-45ed-8807-0af47b446cac2026-03-05WarningsName fallback
generic name: GUAIFENESIN

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 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0325Good Sense Mucus ERGuaifenesinL. Perrigo CompanyANDACurrent
0113-0325Good Sense Mucus ERGuaifenesinL. Perrigo CompanyANDACurrent
0363-0325mucus relief erGuaifenesinWalgreen CompanyANDACurrent
11673-325Up and Up mucus reliefGuaifenesinTarget CorporationANDACurrent
11673-325Up and Up mucus reliefGuaifenesinTarget CorporationANDACurrent
11822-0325mucus reliefGuaifenesinRite Aid CorporationANDACurrent
11822-0325mucus reliefGuaifenesinRite Aid CorporationANDACurrent
21130-086Signature Care Mucus Relief MaxGuaifenesinSafewayANDACurrent
21130-086Signature Care Mucus Relief MaxGuaifenesinSafewayANDACurrent
30142-325mucus er maxGuaifenesinKroger CompanyANDACurrent
36800-325TopCare Mucus ERGuaifenesinTopco Associates LLCANDACurrent
37012-325Mucus ER MaxGuaifenesinShopko Stores Operating Co., LLCANDACurrent
37808-325mucus erGuaifenesinH E BANDACurrent
37808-325mucus erGuaifenesinH E BANDACurrent
41163-325Equaline Mucus ERGuaifenesinSupervalu IncANDACurrent
41250-325Mucus ERGuaifenesinMeijer Distribution IncANDACurrent
41250-672maximum strength mucus reliefGuaifenesinMeijer Distribution IncANDACurrent
45802-325Guaifenesin Extended ReleaseGuaifenesinPerrigo New York IncANDACurrent
45802-325Guaifenesin Extended ReleaseGuaifenesinPadagis Israel Pharmaceuticals LtdANDACurrent
45802-325Guaifenesin Extended ReleaseGuaifenesinPerrigo New York IncANDACurrent
46122-351Good Neighbor Pharmacy Mucus ERGuaifenesinAmerisource BergenANDACurrent
46122-351Good Neighbor Pharmacy Mucus ERGuaifenesinAmerisource BergenANDACurrent
49035-325Equate Mucus ER MaxGuaifenesinWal-Mart Stores IncANDACurrent
49035-325Equate Mucus ER MaxGuaifenesinWal-Mart Stores IncANDACurrent
49738-325Smart Sense Mucus Relief ERGuaifenesinKmart CorporationANDACurrent
55316-325Healthy Accents Mucus ReliefGuaifenesinDZA Brands LLCANDACurrent
55910-728DG Health Mucus ERGuaifenesinDolgencorp, LLCANDACurrent
59779-948Mucus Extended ReleaseGuaifenesinCVS PharmacyANDACurrent
59779-948Mucus Extended ReleaseGuaifenesinCVS PharmacyANDACurrent
59779-948Mucus Extended ReleaseGuaifenesinCVS PharmacyANDACurrent
62011-0299Health Mart Mucus ERGuaifenesinMckessonANDACurrent
62011-0299Health Mart Mucus ERGuaifenesinStrategic Sourcing Services LLCANDACurrent
68196-325Members Mark mucus relief ERGuaifenesinSam's West IncANDACurrent
69256-325Harris Teeter Mucus Relief MaxGuaifenesinHarris Teeter, LLCANDACurrent
70000-0167Leader Mucus ER MaxGuaifenesinCardinal HealthANDACurrent
70000-0167Leader Mucus ER MaxGuaifenesinCardinal HealthANDACurrent
70677-0035sunmark mucus erGuaifenesinStrategic Sourcing Services LLCANDACurrent
70677-0035sunmark mucus erGuaifenesinStrategic Sourcing Services LLCANDACurrent