Equate Mucus ER

Product NDC
49035-498
11-digit product format
490350498
Labeler code
49035
Product ID
49035-498_f41273ab-e849-4d00-a138-f7be68d8316d
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA078912
Marketing category
ANDA
Marketing start
2013-03-22
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
600 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49035-498DDiscontinued by firm2026-08-10
excluded packagepackage49035-49849035-498-39DDiscontinued by firm2026-08-10
excluded packagepackage49035-49849035-498-58DDiscontinued by firm2026-08-10
excluded packagepackage49035-49849035-498-60DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-498-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-498-39d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-498-58d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-498-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-498-39f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-498-58f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49035-498-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49035-498-392ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49035-498-582ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49035-498-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49035-498-39a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49035-498-58a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49035-498-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49035-498-39cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49035-498-58cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49035-498-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49035-498-39cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49035-498-58cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49035-498-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49035-498-39302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49035-498-58302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-498-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-498-39ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-498-58ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-498-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-498-390efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-498-580efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49035-498-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49035-498-39ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49035-498-58ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49035-498-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49035-498-39367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49035-498-58367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49035-498-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49035-498-39557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49035-498-58557ba5c1ecfa…9c80585c8c6e…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-498-60EA - Each49035-498f5aee200-f16b-4f92-8964-f1dc560c5e1112015-08-04

DailyMed Socrata Ingredients#

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
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
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