Mucus Relief

Product NDC
11822-0731
11-digit product format
118220731
Labeler code
11822
Product ID
11822-0731_f9438448-b525-47e4-82ac-40f2d4e170cb
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA207342
Marketing category
ANDA
Marketing start
2019-05-31
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
600 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11822-0731DDiscontinued by firm2026-10-15
excluded packagepackage11822-073111822-0731-1DDiscontinued by firm2026-10-15
excluded packagepackage11822-073111822-0731-6DDiscontinued by firm2026-10-15

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 · 9 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11822-0731-6fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11822-0731-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11822-0731-686f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11822-0731-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11822-0731-6bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11822-0731-1bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A207342-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2018-07-11c2088c7a36db…
2026-10-15 13:18:302026-09A207342-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2018-07-11c2088c7a36db…
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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0731MUCUS RELIEF (GUAIFENESIN) TABLET [RITE AID CORPORATION]3Legacy NDC20230221_b091ace8-72ab-426a-bba6-97787805f63e.zip

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
11822-0731-111822073101100 BLISTER PACK in 1 CARTON (11822-0731-1) > 1 TABLET in 1 BLISTER PACK100 blister pack2019-05-310000-00-00NoNoCurrent
11822-0731-61182207310668 BLISTER PACK in 1 CARTON (11822-0731-6) > 1 TABLET in 1 BLISTER PACK68 blister pack2019-05-310000-00-00NoNoCurrent