Leader Clear Lax

Product NDC
37205-612
11-digit product format
372050612
Labeler code
37205
Product ID
37205-612_d3fa6d00-848d-43df-9df1-0f8deee3f582
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Cardinal Health
Application
ANDA090685
Marketing category
ANDA
Marketing start
2009-10-26
Marketing end
2021-11-30
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/17g
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37205-612DDiscontinued by firm2026-08-03
excluded packagepackage37205-61237205-612-71DDiscontinued by firm2026-08-03
excluded packagepackage37205-61237205-612-72DDiscontinued by firm2026-08-03
excluded packagepackage37205-61237205-612-73DDiscontinued by firm2026-08-03

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 packagepackage37205-612-72d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37205-612-73d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37205-612-71d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37205-612-72f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37205-612-73f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37205-612-71f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37205-612-722ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37205-612-732ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37205-612-712ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37205-612-72a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37205-612-73a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37205-612-71a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37205-612-72cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37205-612-73cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37205-612-71cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37205-612-72cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37205-612-73cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37205-612-71cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37205-612-72302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37205-612-73302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37205-612-71302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37205-612-72ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37205-612-73ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37205-612-71ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37205-612-720efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37205-612-730efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37205-612-710efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37205-612-72ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37205-612-73ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37205-612-71ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37205-612-72367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37205-612-73367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37205-612-71367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37205-612-72557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37205-612-73557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37205-612-71557ba5c1ecfa…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
A090685-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06
A090685-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-612-71GM - Gram37205-612914cc494-8b1d-4265-96fe-e639a99958d912012-07-24
37205-612-72GM - Gram37205-61227806909-abf1-491c-ac62-175428b3adb912012-07-24
37205-612-73GM - Gram37205-61210ffb865-5cbd-4793-808e-a8ad936b98f012012-07-24

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 3 · 51 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clear laxPOLYETHYLENE GLYCOL 3350HyVee Inc5bcf01d8-ddf3-4e64-8d3f-3526a51a58592026-07-02WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
CLEARLAXPOLYETHYLENE GLYCOL 3350Safewaya70f41d0-0fad-4d15-8844-d60eabeb67322026-07-02WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-07-02WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
smooth laxPOLYETHYLENE GLYCOL 3350Walgreen Company3027af65-2f7f-472d-83f5-254d5d75013c2026-05-08WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
clear laxPOLYETHYLENE GLYCOL 3350Meijer Distribution Inc6464f12c-0883-46c5-943b-a84fe235588e2026-04-13WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
equate clear laxPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc56a507f3-0cd1-4f02-9dfd-de297ba4bc1f2026-03-27WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
foster and thrive clearlaxPOLYETHYLENE GLYCOL 3350Strategic Sourcing Services LLC684e35cc-5a4f-458d-b5e7-e1933fea11392026-03-07WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Topcare ClearLaxPOLYETHYLENE GLYCOL 3350Topco Associates LLC03291fd3-7b64-4b79-ad84-e1b9b30a6b032026-02-19WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Good Sense Clear LaxPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals Inc.935f05da-3637-4a9e-843e-1f2ced5d1a742026-01-23WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
MiraLAX Orange FlavorPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.0a5b2121-928f-8f49-e063-6394a90a8aaf2025-12-04WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350A-S Medication Solutions4f31a33e-1f60-4aa7-b1dc-a3c011c03a702025-10-29WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
LaxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation457f5d2d-4595-482a-9ffa-659fb5d5b1342025-10-09WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack5df518fb-ad58-4f17-af34-f66066f1313a2025-09-30WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
DulcolaxPOLYETHYLENE GLYCOL 3350Chattem, Inc.ed16d0f4-74e7-4fa3-989d-c6840a5d3e712025-09-30WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
kirkland signature laxaclear original prescription strengthPOLYETHYLENE GLYCOL 3350Costco Wholesale Companyf58fa5c0-8ab7-4427-aea0-d536b47acbb52025-09-18WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
up and up powderlaxPOLYETHYLENE GLYCOL 3350Target Corporation1bceb457-b24f-485d-bfe2-af4b7d38a5c22025-09-18WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
clearlaxPOLYETHYLENE GLYCOL 3350Meijer, Inc.8cca18a8-94f6-43f6-bdb7-2d44a6cdf1512025-08-08WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
good neighbor pharmacy clearlaxPOLYETHYLENE GLYCOL 3350Amerisource Bergene0b419b6-6ce0-4aaa-948f-dee5b2ec20822025-04-17WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2025-03-21WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
clear laxPOLYETHYLENE GLYCOL 3350H E Bbd16827b-5e6a-4fa7-bc2e-c9a05e1e2dab2024-12-02WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37205-612-7137205061271119 g in 1 BOTTLE (37205-612-71) 119 g2009-10-260000-00-00NoNoCurrent
37205-612-7237205061272238 g in 1 BOTTLE (37205-612-72) 238 g2009-10-260000-00-00NoNoCurrent
37205-612-7337205061273510 g in 1 BOTTLE (37205-612-73) 510 g2009-10-260000-00-00NoNoCurrent