FDA.reportPublic FDA data

Application 078912

Type
ANDA
Sponsor
PERRIGO R AND D

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 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
A078912-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23
A078912-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05

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 2 · 77 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-23782e0a99824c…
2021-12-28 21:50 UTC2021-12A078912-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-11-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078912-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2011-11-2387673890dc5c…

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 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
mucus reliefGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51194399-6ded-4142-8880-9e810e6283522026-07-13WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
equate mucus-erGUAIFENESINWALMART INC.a2cc6dec-388a-46bd-9cbc-1ffb6fd1aea32026-07-02WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
RUGBY MUCUS RELIEF ERGUAIFENESINRugby Laboratoriesb82ba4cb-8e96-41cc-81c4-ab976410fa302026-06-15WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
mucus reliefGUAIFENESINRite Aid Corporation0c68d8f0-7e02-42b3-8150-2ed66a13e2822026-06-03WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
ndc (product): 11822-2123
equate mucus reliefGUAIFENESINWALMART INC.154602ca-91c4-4030-ae77-9bf179cc95e82026-05-26WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
MUCUS RELIEFGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED2caa7f8e-695c-441a-a968-fcc3f527d1172026-05-13WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
good sense mucus erGUAIFENESINRedpharm Drug4fb57f87-f761-b52e-e063-6294a90ae4ee2026-04-18WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
Leader Mucus ReliefGUAIFENESINCardinal Health 110, LLC. dba Leaderca735722-0baa-4c85-8311-17dbce915fc52026-04-08WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
mucus erGUAIFENESINHyVee Inc851f49b5-34a0-4c58-90fa-51e265c7f7312026-03-26WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
MUCUS AND CHEST CONGESTIONGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf341aa99-5339-4087-a98a-469231dfc6d02026-02-17WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
up and up mucus reliefGUAIFENESINTarget Corporation7c1598f1-1236-48d2-861b-de4715e3f3d22026-02-05WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
ndc (product): 11673-421
mucus erGUAIFENESINHyVee Inc74136552-55b2-4dee-9c66-3f84e9dc63d62026-02-03WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
MUCUS AND CHEST CONGESTIONGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf505e0bd-8881-4e51-a2fc-4e649bac3bff2026-01-14WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
UP AND UP MUCUS RELIEFGUAIFENESINTarget Corporation059cff23-b6a5-40dc-ac4e-9bcb552e97642025-09-22WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
Good Sense Mucus ERGUAIFENESINL. Perrigo Company30860399-d9a3-409b-bfac-00597c74b1752025-07-16WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
basic care mucus er maxGUAIFENESINAmazon.com Services LLC3552346e-4650-44c1-9233-57251a0291332025-07-02WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
Good Neighbor Pharmacy Mucus ERGUAIFENESINAmerisource Bergen5810b584-bbfa-4dd2-b237-71520a214c092025-06-17WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
mucus extended releaseGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED9fcf96a7-bef4-4cc8-bd9e-c245ccbea17d2025-06-17WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
Rugby Mucus Relief ERGUAIFENESINRugby Laboratories1c579aea-c9c5-44d0-997b-f350f84ac6d02025-06-17WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912
DG health mucus er maxGUAIFENESINDolgencorp Inc4353d561-0e6d-4d36-b356-dd6506b5a3ee2025-06-06WarningsExact identifier
application applno (ANDA): 078912
application number: ANDA078912

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-2023good sense mucus erguaifenesinL. Perrigo CompanyANDACurrent
0113-2023good sense mucus erguaifenesinL. Perrigo CompanyANDACurrent
0615-7712Guaifenesin Extended ReleaseGuaifenesinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
11673-421up and up mucus reliefguaifenesinTarget CorporationANDACurrent
11673-421up and up mucus reliefguaifenesinTarget CorporationANDACurrent
11822-2123mucus reliefguaifenesinRite Aid CorporationANDACurrent
41250-684mucus reliefGuaifenesinMeijer Distribution IncANDACurrent
41250-684mucus reliefGuaifenesinMeijer Distribution IncANDACurrent
41250-684mucus reliefGuaifenesinMeijer Distribution IncANDACurrent
49035-498Equate Mucus ERGuaifenesinWal-Mart Stores IncANDACurrent
55910-310DG Health Mucus ERGuaifenesinDolgencorp IncANDACurrent
64024-222welby mucus reliefguaifenesinAldi IncANDACurrent
64024-222welby mucus reliefguaifenesinAldi IncANDACurrent
69842-806mucusguaifenesinCVS PharmacyANDACurrent
72288-298basic care mucus erGuaifenesinAmazon.com Services LLCANDACurrent
72288-298basic care mucus erGuaifenesinAmazon.com Services LLCANDACurrent
72288-298basic care mucus erGuaifenesinAmazon.com Services LLCANDACurrent
72288-298basic care mucus erGuaifenesinAmazon.com Services LLCANDACurrent
76162-123Topcare mucus erguaifenesinTopco Associates LLCANDACurrent
81522-006caring mill mucus erguaifenesinFSA Store Inc.ANDACurrent