sunmark clearlax

Product NDC
49348-893
11-digit product format
493480893
Labeler code
49348
Product ID
49348-893_fb2bd65f-ef43-4ed1-91c3-248687ae6a10
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA090685
Marketing category
ANDA
Marketing start
2009-10-07
Marketing end
0000-00-00
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/17g
Pharmacologic classes
Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49348-893DDiscontinued by firm2026-10-05
excluded packagepackage49348-89349348-893-50DDiscontinued by firm2026-10-05
excluded packagepackage49348-89349348-893-70DDiscontinued by firm2026-10-05
excluded packagepackage49348-89349348-893-92DDiscontinued 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 · 26 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 packagepackage49348-893-70d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-893-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-893-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-893-70f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-893-92f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49348-893-702ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49348-893-922ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49348-893-70a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49348-893-92a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49348-893-70cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49348-893-92cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49348-893-70cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49348-893-92cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49348-893-70302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49348-893-92302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49348-893-70ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49348-893-92ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49348-893-700efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49348-893-920efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49348-893-92ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49348-893-70ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49348-893-92367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49348-893-70367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49348-893-92557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49348-893-70557ba5c1ecfa…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
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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0684e616aacf4f…
2026-08-18 06:07:402026-07A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06caaa826d4ba7…
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…

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-893-50GM - Gram49348-8936986bd85-c35f-43e2-89b9-63d1d0e8358f12012-07-24
49348-893-70GM - Gram49348-89320f79b96-5f6c-4beb-a088-aef2886f575b12012-07-24
49348-893-92GM - Gram49348-89363e85343-407e-42ed-bcc2-36dd81f58cd412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PSUNMARK CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [MCKESSON]3
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PSUNMARK CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [MCKESSON]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-893SUNMARK CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [STRATEGIC SOURCING SERVICES LLC]10Legacy NDC20241225_12963962-a170-40f6-ac2d-210dff6fabae.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 3 · 48 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
clear laxPOLYETHYLENE GLYCOL 3350H E Bbd16827b-5e6a-4fa7-bc2e-c9a05e1e2dab2024-12-02WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Leader ClearLaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader9b759bd9-3818-4b71-a99c-aa7e202bf22e2024-10-01WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
rugby PEG 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepackfb3f889c-7f88-4850-9994-d436f90109902024-09-06WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Members Mark clearlaxPOLYETHYLENE GLYCOL 3350Sam's West Inc5bc34a90-adc2-4031-b8a6-7258298815502024-09-05WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
GENTLELAXPOLYETHYLENE GLYCOL 3350Kroger Company2390b507-93d5-43a0-aa51-31ca4edd6b7f2024-07-03WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
careone clearlaxPOLYETHYLENE GLYCOL 3350Retail Business Services, LLC2378b76d-dc5a-4ff1-ad48-9f3e0c31c6cd2024-05-19WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
smoothlaxPOLYETHYLENE GLYCOL 3350Walgreen Companyaeb5c32c-443e-4ea3-8e96-fed38225fdf32024-03-12WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Topcare ClearLaxPOLYETHYLENE GLYCOL 3350Topco Associates LLC02f81a86-bec5-4e8b-bddb-d463ae2ea9e92024-02-07WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Welby ClearLaxPOLYETHYLENE GLYCOL 3350Aldi, Incd64caba5-614f-4edc-bb47-ce4fed38ce452023-11-10WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
equaline clearlaxPOLYETHYLENE GLYCOL 3350United Natural Foods, Inc. dba UNFIe0871542-9136-4cf8-a4b7-6c2b6edcbe0e2023-08-07WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
good sense clearlaxPOLYETHYLENE GLYCOL 3350L. Perrigo Company9858edef-cdb2-4ac4-8e4b-ba0720a24e412023-06-01WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
berkley and jensen clearlaxPOLYETHYLENE GLYCOL 3350BJWCf9eb9023-c83b-49b4-af82-d8344ffa46c32023-05-12WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
dg health clearlaxPOLYETHYLENE GLYCOL 3350Dolgencorp Incffae36fd-2fb7-4afb-a7f8-29c700a477fb2023-05-04WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
clearlaxPOLYETHYLENE GLYCOL 3350Publix Super Markets Incee30489a-8683-4403-8f85-76434242663c2023-02-15WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Good Neighbor Pharmacy ClearLaxPOLYETHYLENE GLYCOL 3350Amerisource Bergen4f2d3ef2-5097-4653-8dab-de5ba1fb9c412023-02-15WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
laxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation3ebe9191-8e0a-41cf-b759-82ecce4f50e42023-02-10WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
880407ClearLax 17 GM Powder for Oral SolutionPSNac87ef10-1a56-4f0d-9c00-775095e960746
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNac87ef10-1a56-4f0d-9c00-775095e960746
880407polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]SBDac87ef10-1a56-4f0d-9c00-775095e960746
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDac87ef10-1a56-4f0d-9c00-775095e960746
880407ClearLax 17 GM Powder for Oral SolutionSYac87ef10-1a56-4f0d-9c00-775095e960746
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYac87ef10-1a56-4f0d-9c00-775095e960746

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-893-5049348089350119 g in 1 BOTTLE (49348-893-50) 119 g2009-10-070000-00-00NoNoCurrent
49348-893-7049348089370238 g in 1 BOTTLE (49348-893-70) 238 g2009-10-070000-00-00NoNoCurrent
49348-893-9249348089392510 g in 1 BOTTLE (49348-893-92) 510 g2009-10-070000-00-00NoNoCurrent