Mucus Relief

Product NDC
37012-727
11-digit product format
370120727
Labeler code
37012
Product ID
37012-727_530d5715-9186-47c3-bbe2-f223778d4910
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Shopko Stores Operating Co., LLC.
Application
ANDA207342
Marketing category
ANDA
Marketing start
2018-12-31
Marketing end
2024-02-29
Substance
GUAIFENESIN
Active strength
1200 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37012-727DDiscontinued by firm2026-10-05
excluded packagepackage37012-72737012-727-28DDiscontinued by firm2026-10-05

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 · 24 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 packagepackage37012-727-28d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37012-727-28f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37012-727-282ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37012-727-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37012-727-28cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37012-727-28cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37012-727-28302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37012-727-28ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37012-727-280efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37012-727-28ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37012-727-28367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37012-727-28557ba5c1ecfa…9c80585c8c6e…

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
A207342-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11
A207342-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11

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 22:38:342026-08A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1184e616aacf4f…
2026-09-14 22:38:342026-08A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1184e616aacf4f…
2026-08-18 06:07:402026-07A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-1174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-11-17Drug Facts
2020-09-27Drug Facts
2020-09-25Drug Facts
2020-07-22Drug Facts

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 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus ReliefGUAIFENESINUnited Natural Foods, Inc. dba UNFIe7d457a6-05f9-407c-bf9b-a82e3cf2568c2023-09-07WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC3578086b-f961-4494-9bbd-5305320487272023-04-21WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Extended Release Maximum StrengthGUAIFENESINH E B6f075c29-8256-4cac-96c4-a772a53ad21d2022-12-09WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Extended ReleaseGUAIFENESINCare One (American Sales Company)96569c70-0936-4041-ab32-2b2262402f342022-11-21WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus Relief Maximum StrengthGUAIFENESINCare One (American Sales Company)c94e3943-20da-4bd4-b0ff-6aa60b03a1bf2022-11-21WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINH E B562b6ab6-4795-4909-8008-e919173844c92022-11-07WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342
Mucus ReliefGUAIFENESINWinCo Foods, LLC90e72075-d08a-41c8-a6b0-5fbb99a7ea412022-05-11WarningsExact identifier
application applno (ANDA): 207342
application number: ANDA207342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37012-727-283701207272828 BLISTER PACK in 1 CARTON (37012-727-28) > 1 TABLET in 1 BLISTER PACK28 blister pack2018-12-310000-00-00NoNoCurrent