FDA.reportPublic FDA data

Application 091070

Type
ANDA
Sponsor
ACTAVIS LABS FL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESINTABLET, EXTENDED RELEASE;ORAL30MG;600MGNoNo
002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESINTABLET, EXTENDED RELEASE;ORAL60MG;1.2GMNoNo

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
A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-31
A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-31

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 22:38:342026-08A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-3184e616aacf4f…
2026-09-14 22:38:342026-08A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-3184e616aacf4f…
2026-08-18 06:07:402026-07A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091070-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2015-08-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091070-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2015-08-3174a2ff9319b5…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY, INCdd00dfc0-e523-4dec-8fc0-50363eadec572026-04-20WarningsName fallback
brand name: Guaifenesin and Dextromethorphan Hydrobromide
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack9a77465c-6d3a-4399-9734-ad22e4b435db2026-03-18WarningsName fallback
brand name: Guaifenesin and Dextromethorphan Hydrobromide
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals1538bf63-d020-3ba2-e063-6294a90aecc52025-10-21WarningsName fallback
brand name: Guaifenesin and Dextromethorphan Hydrobromide
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals389230e5-775e-5b0d-e054-00144ff88e882025-10-21WarningsName fallback
brand name: Guaifenesin and Dextromethorphan Hydrobromide
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEInvaTech Pharma Solutions LLC40288ecf-043d-eb9e-e063-6394a90ac0a72025-10-02WarningsName fallback
brand name: Guaifenesin and Dextromethorphan Hydrobromide

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0735Mucus Relief DMDextromethorphan HBr, GuaifenesinWalgreen CompanyANDACurrent
0363-0735Mucus Relief DMDextromethorphan HBr, GuaifenesinWalgreen CompanyANDACurrent
11673-735Up and Up Mucus Relief DMDextromethorphan HBr, GuaifenesinTarget CorporationANDACurrent
11822-0735mucus relief DMDextromethorphan HBr, GuaifenesinRite Aid CorporationANDACurrent
21130-115Signature Care Mucus Relief DMDextromethorphan HBr, GuaifenesinSafewayANDACurrent
30142-735Mucus DM MaxDextromethorphan HBr, GuaifenesinKroger CompanyANDACurrent
36800-735TopCare Mucus DMDextromethorphan HBr, GuaifenesinTopco Associates LLCANDACurrent
37012-806Mucus DM MaxDextromethorphan HBr, GuaifenesinShopko Stores Operating Co., LLCANDACurrent
41163-735Equaline Mucus DMDextromethorphan HBr, GuaifenesinSupervalu IncANDACurrent
41250-735Mucus DMDextromethorphan HBr, GuaifenesinMeijer Distribution IncANDACurrent
46122-348Good Neighbor Pharmacy Mucus DMDextromethorphan HBr, GuaifenesinAmerisource BergenANDACurrent
49035-735Equate Mucus DMDextromethorphan HBr, GuaifenesinWal-Mart Stores IncANDACurrent
49348-199Sunmark mucus relief DMDextromethorphan HBr, GuaifenesinMckessonANDACurrent
49348-199Sunmark mucus relief DMDextromethorphan HBr, GuaifenesinStrategic Sourcing Services LLCANDACurrent
55316-735Healthy Accents Mucus Relief DMDextromethorphan HBr, GuaifenesinDZA Brands LLCANDACurrent
55910-735DG Health Mucus DMDextromethorphan HBr, GuaifenesinDolgencorp, LLCANDACurrent
59779-735Mucus DM Extended ReleaseDextromethorphan HBr, GuaifenesinCVS PharmacyANDACurrent
62011-0302Health Mart mucus relief DMDextromethorphan HBr, GuaifenesinMckessonANDACurrent
62011-0302Health Mart mucus relief DMDextromethorphan HBr, GuaifenesinStrategic Sourcing Services LLCANDACurrent
68196-735Members Mark mucus relief DMDextromethorphan HBr, GuaifenesinSam's West IncANDACurrent
69256-735Harris Teeter Mucus Relief DMDextromethorphan HBr, GuaifenesinHarris Teeter, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9316ORIG2015-09-04