Maximum Strength Mucus Relief

Product NDC
69230-315
11-digit product format
692300315
Labeler code
69230
Product ID
69230-315_bb6801c3-e110-4497-9dbd-b760ff99c255
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Consumer Care
Application
ANDA209215
Marketing category
ANDA
Marketing start
2019-11-06
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
1200 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct69230-315DDiscontinued by firm2026-08-17
excluded packagepackage69230-31569230-315-31DDiscontinued by firm2026-08-17
excluded packagepackage69230-31569230-315-32DDiscontinued by firm2026-08-17

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69230-315-32DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69230-315-31DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69230-315-32DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69230-315-31DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69230-315-32DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69230-315-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69230-315-32DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69230-315-31DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69230-315-32DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69230-315-31DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69230-315-32DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69230-315-31DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69230-315-32DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69230-315-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69230-315-32DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69230-315-31DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69230-315-32DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69230-315-31DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69230-315-31IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69230-315-32IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69230-315-31IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69230-315-32IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69230-315-31IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69230-315-32IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69230-315-31IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69230-315-32IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69230-315-31IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69230-315-32IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69230-315-31IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69230-315-32IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209215-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06
A209215-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209215-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2017-09-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209215-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2017-09-06bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-315-31EA - Each69230-31521230135-05b7-438d-8fb0-7241525535c412020-07-13
69230-315-32EA - Each69230-3159e020397-3866-4dba-bc19-d2bb46baddce12020-07-13

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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuaifenesinGUAIFENESINYYBA CORP4cb11551-31e3-5c01-e063-6394a90ab0d42026-06-24WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
MUCUS RELIEFGUAIFENESINYYBA Corp5074b172-311b-43e2-e063-6394a90aa70f2026-06-22WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Mucus ReliefGUAIFENESINNCS HealthCare of KY, LLC dba Vangard Labs41f4f8df-87d4-459f-af6d-3a4356a8115b2026-06-04WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-03-04WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Topco Mucus ReliefGUAIFENESINTopco Associates, LLC03c17c06-6919-4ef4-9d0a-4c039940c6712025-12-03WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Mucus ReliefGUAIFENESINMajor Pharmaceuticals4d98920b-caf7-42d9-bd08-859d27b6d76a2025-11-24WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Mucus ReliefGUAIFENESINBryant Ranch Prepackc648e711-e944-4574-83b3-ccce8732384e2025-06-02WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Mucus Relief MaxGUAIFENESINDiscount Drug Mart, Inc2df7e36d-8eb6-827b-e063-6294a90acb1d2025-02-24WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Mucus ReliefGUAIFENESINDiscount Drug Mart, Inc2d5940b8-fdae-edf2-e063-6294a90a68fc2025-02-24WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Guaifenesin Extended Release 600 mgGUAIFENESINWal-Mart Stores, Inc.1769c98d-8bce-6bf5-e063-6394a90a64422024-10-22WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Mucus Relief 600 mgGUAIFENESINGuardian Drug Companye7742a43-9066-4e28-a90d-f07c0e18f0452024-04-30WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Equate Mucus ReliefGUAIFENESINWal-Mart Stores, Inc.516c76ac-5e2d-41f9-81bd-20e05f0b23002024-04-09WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Mucus ReliefGUAIFENESINMcKesson Corporation dba SKY Packaging69b61f05-8f0b-420f-b4ef-df933b70eebc2022-11-21WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Mucus ReliefGUAIFENESINAphena Pharma Solutions - Tennessee, LLC01af03f1-5d1b-4893-b7db-7092ba66e8422021-05-03WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215
Guaifenesin Extended-Release 600 mgGUAIFENESINGuardian Drug Company20f9e083-419d-429d-a570-24b312ed5d2a2018-02-28WarningsExact identifier
application applno (ANDA): 209215
application number: ANDA209215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-315-31692300315312 BLISTER PACK in 1 CARTON (69230-315-31) > 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2019-11-060000-00-00NoNoCurrent
69230-315-32692300315324 BLISTER PACK in 1 CARTON (69230-315-32) > 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2019-11-060000-00-00NoNoCurrent