FDA.reportPublic FDA data

Application 207602

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

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

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
A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05
A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05

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 UTC2026-02A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207602-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2018-03-05782e0a99824c…
2021-12-28 21:50 UTC2021-12A207602-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2018-03-05782e0a99824c…

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 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Mucus DMDEXTROMETHORPHAN HBR, GUAIFENESINTopco Associates LLC60108084-4be9-4e8a-b354-9438e1694ebc2025-07-03WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
ndc (product): 36800-592
up and up mucus relief dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINTarget Corporation9cb3719b-44bc-4ad1-a9c5-e6cc047f4d0e2025-05-07WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
ndc (product): 11673-716
mucus relief dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer Distribution Incd41749b4-735b-44f7-ab06-244f68e031e32025-05-07WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
ndc (product): 41250-436
members mark mucus relief dmDEXTROMETHORPHAN HBR, GUAIFENESINSam's West Inc3db5409d-d772-4bf1-a183-37fbe01d53d62025-04-04WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
Rugby Mucus Relief DM ERDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratoriesf2629794-4845-4ca6-8668-a21a56f182cb2025-04-02WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
Leader Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leader7c54d128-9da7-49d7-bda4-9d4f7b8bc6522025-03-08WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
GOOD SENSE MUCUS DMDEXTROMETHORPHAN HBR, GUAIFENESINA-S Medication Solutions9995f480-da71-4e3b-8154-9eefaeb9299d2024-09-26WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
Robitussin Maximum Strength 12 Hour Cough and Mucus ReliefDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLC96409b52-b0ec-444b-bc39-fd41070e98552024-04-07WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
ndc (product): 0031-8765
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Companyd8a693f7-03c1-4583-89a8-8d506a894b242024-02-11WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
mucus relief dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Companyba200f15-56dd-4b4d-9f3f-1340f3cb73a52024-02-01WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
ndc (product): 0363-6812
equaline mucus dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINUnited Natural Foods, Inc. dba UNFI1db69578-2331-4fce-91a4-95c54cb7dc072023-08-07WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
ndc (product): 41163-599
Equaline Mucus DMDEXTROMETHORPHAN HBR, GUAIFENESINUnited Natural Foods, Inc. dba UNFI04334889-f75e-4a19-a8b4-47b8db18b9aa2023-08-02WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
ndc (product): 41163-781
DG health mucus dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inca95401cc-349e-435a-b953-4d8fd1f547442023-02-01WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
DG health mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, LLCadd72ca5-94cd-437f-b30f-6149c08b5f212022-11-14WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
ndc (product): 55910-575
basic care mucus dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC3534e3e8-aaf5-429e-91be-830a8d6310642021-08-06WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
ndc (product): 72288-219
basic care mucus dmDEXTROMETHORPHAN HBR, GUAIFENESINAmazon.com Services LLCac01ad52-483a-4cce-9279-51ceecada9b92021-07-13WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
ndc (product): 72288-812
equate mucus relief dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWal-Mart Stores Inc1ceed839-93d0-4124-9fb8-63fbb97b75ac2021-06-29WarningsExact identifier
application applno (ANDA): 207602
application number: ANDA207602
ndc (product): 79903-065

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0031-8765Robitussin Maximum Strength 12 Hour Cough and Mucus ReliefDextromethorphan Hydrobromide, GuaifenesinWyeth Consumer Healthcare LLCANDACurrent
0031-8765Robitussin Maximum Strength 12 Hour Cough and Mucus ReliefDextromethorphan Hydrobromide, GuaifenesinGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0113-0812good sense mucus dmdextromethorphan HBr, guaifenesinL Perrigo CompanyANDACurrent
0113-0812good sense mucus dmdextromethorphan HBr, guaifenesinL Perrigo CompanyANDACurrent
0113-2219Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesinL. Perrigo CompanyANDACurrent
0113-2219Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesinL. Perrigo CompanyANDACurrent
0113-7419basic care mucus dmdextromethorphan hydrobromide, guaifenesinL. Perrigo CompanyANDACurrent
0113-7812basic care mucus dmdextromethorphan HBr, guaifenesinL. Perrigo CompanyANDACurrent
0113-7812basic care mucus dmdextromethorphan HBr, guaifenesinL. Perrigo CompanyANDACurrent
0280-1660Alka-Seltzer Plus Maximum Strength Cough and Mucus DMDextromethorphan Hydrobromide, GuaifenesinBayer HealthCare LLC.ANDACurrent
0280-1660Alka-Seltzer Plus Maximum Strength Cough and Mucus DMDextromethorphan Hydrobromide, GuaifenesinBayer HealthCare LLC.ANDACurrent
0280-1660Alka-Seltzer Plus Maximum Strength Cough and Mucus DMDextromethorphan Hydrobromide, GuaifenesinBayer HealthCare LLC.ANDACurrent
0363-6812mucus relief dmdextromethorphan hydrobromide, guaifenesinWalgreen CompanyANDACurrent
0536-1199rugby mucus relief dmdextromethorphan HBr, guaifenesinRugby LaboratoriesANDACurrent
11673-235up and up maximum strength mucus relief dmdextromethorphan hydrobromide, guaifenesinTarget CorporationANDACurrent
11673-235up and up maximum strength mucus relief dmdextromethorphan hydrobromide, guaifenesinTarget CorporationANDACurrent
11673-716up and up mucus relief dmdextromethorphan hydrobromide, guaifenesinTarget CorporationANDACurrent
11673-716up and up mucus relief dmdextromethorphan hydrobromide, guaifenesinTarget CorporationANDACurrent
36800-219Topcare Mucus DMdextromethorphan hydrobromide, guaifenesinTopco Associates LLCANDACurrent
36800-219Topcare Mucus DMdextromethorphan hydrobromide, guaifenesinTopco Associates LLCANDACurrent
36800-592Topcare Mucus DMdextromethorphan HBr, guaifenesinTopco Associates LLCANDACurrent
36800-592Topcare Mucus DMdextromethorphan HBr, guaifenesinTopco Associates LLCANDACurrent
37808-812mucus relief dmdextromethorphan HBr, guaifenesinH E BANDACurrent
41163-599equaline mucus dmdextromethorphan hydrobromide, guaifenesinSupervalu IncANDACurrent
41163-781Equaline Mucus DMdextromethorphan HBr, guaifenesinSupervalu IncANDACurrent
41250-436mucus relief dmdextromethorphan hydrobromide, guaifenesinMeijer Distribution IncANDACurrent
41250-812mucus dmdextromethorphan HBr, guaifenesinMeijer Distribution IncANDACurrent
46122-637good neighbor pharmacy mucus dmdextromethorphan HBr, guaifenesinAmerisource BergenANDACurrent
50594-812sound body mucus dmdextromethorphan Hydrobromide, guaifenesinBig Lots Stores, Inc.ANDACurrent
55301-812Exchange Select Mucus DMdextromethorphan HBr, guaifenesinArmy & Air Force Exchange ServiceANDACurrent
55910-575DG health mucus dmdextromethorphan HBr, guaifenesinDolgencorp, LLCANDACurrent
55910-575DG health mucus dmdextromethorphan HBr, guaifenesinDolgencorp, LLCANDACurrent
55910-575DG health mucus dmdextromethorphan HBr, guaifenesinDolgencorp, LLCANDACurrent
68391-812Berkley and Jensen Mucus Relief DMdextromethorphan HBr, guaifenesinBJWCANDACurrent
69842-812mucus dm extended releaseguaifenesin, dextromethorphan HBrCVS PharmacyANDACurrent
69842-963mucus dm extended releaseguaifenesin, dextromethorphan hydrobromideCVS PharmacyANDACurrent
70000-0372Leader Mucus DMdextromethorphan HBr, guaifenesinCardinal HealthANDACurrent
70000-0372Leader Mucus DMdextromethorphan HBr, guaifenesinCardinal Health 110, LLC. dba LeaderANDACurrent
72288-219basic care mucus dmdextromethorphan hydrobromide, guaifenesinAmazon.com Services LLCANDACurrent
72288-812basic care mucus dmdextromethorphan HBr, guaifenesinAmazon.com Services LLCANDACurrent
79903-065equate mucus relief dmdextromethorphan hydrobromide, guaifenesinWal-Mart Stores IncANDACurrent
81522-812caring mill mucus dmdextromethorphan HBr, guaifenesinFSA Store Inc.ANDACurrent