Mucus Relief

Product NDC
11822-7329
11-digit product format
118227329
Labeler code
11822
Product ID
11822-7329_4bc8d1d6-6f9c-4bf1-8ae2-9558f7b5d73e
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA207342
Marketing category
ANDA
Marketing start
2020-01-31
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
1200 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct11822-7329DDiscontinued by firm2026-10-12
excluded packagepackage11822-732911822-7329-2DDiscontinued by firm2026-10-12
excluded packagepackage11822-732911822-7329-8DDiscontinued by firm2026-10-12

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 · 21 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11822-7329-8IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11822-7329-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11822-7329-8IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11822-7329-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11822-7329-8IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11822-7329-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11822-7329-8IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11822-7329-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11822-7329-8UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11822-7329-2UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11822-7329-8UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11822-7329-2UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11822-7329-8UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11822-7329-2UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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.

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
11822-7329-22025-08-20Drug Facts
11822-7329-82025-08-20Drug Facts
11822-7329-22025-01-30Drug Facts
11822-7329-82025-01-30Drug Facts
11822-7329-22023-02-20Drug Facts
11822-7329-82023-02-20Drug Facts
11822-7329-22023-01-30Drug Facts
11822-7329-82023-01-30Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-7329MUCUS RELIEF MAXIMUM STRENGTH (GUAIFENESIN) TABLET [RITE AID CORPORATION]3Legacy NDC20230221_de1258c1-a8d7-45a5-b099-39ceefcedc8d.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
11822-7329-21182273290214 BLISTER PACK in 1 CARTON (11822-7329-2) > 1 TABLET in 1 BLISTER PACK14 blister pack2020-01-310000-00-00NoNoCurrent
11822-7329-81182273290828 BLISTER PACK in 1 CARTON (11822-7329-8) > 1 TABLET in 1 BLISTER PACK28 blister pack2020-01-310000-00-00NoNoCurrent