FDA.reportPublic FDA data

basic care clearlax

Product NDC
72288-499
11-digit product format
722880499
Labeler code
72288
Product ID
72288-499_f54ecac7-e6d8-44bd-87da-8306457e8cd5
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA090685
Marketing category
ANDA
Marketing start
2020-06-22
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
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72288-49972288-499-52DDiscontinued by firm2026-10-12

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.

Additional Listing Data#

Finished product
Yes
Brand name base
basic care clearlax
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G2M7P15E5PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
876193Internal RxNorm lookup
880407Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ccb8604-34f6-4e1e-beed-eb81d6aa7aefAvailable on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-499-02basic care clearlax238 g in 1 BOTTLEPOWDER, FOR SOLUTION2386
72288-499-03basic care clearlax510 g in 1 BOTTLEPOWDER, FOR SOLUTION5106
72288-499-09basic care clearlax765 g in 1 BOTTLEPOWDER, FOR SOLUTION7656
72288-499-52basic care clearlax17 g in 1 POUCHPOWDER, FOR SOLUTION176
72288-499-52basic care clearlax10 in 1 CARTONPOWDER, FOR SOLUTION106
72288-499-78basic care clearlax17 g in 1 POUCHPOWDER, FOR SOLUTION176
72288-499-78basic care clearlax100 in 1 CARTONPOWDER, FOR SOLUTION1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-499BASIC CARE CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [AMAZON.COM SERVICES LLC]6Current NDC, Legacy NDC, 7 package rows20230219_1ccb8604-34f6-4e1e-beed-eb81d6aa7aef.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 · 43 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
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
good sense clearlaxPOLYETHYLENE GLYCOL 3350L. Perrigo Company9858edef-cdb2-4ac4-8e4b-ba0720a24e412023-06-01WarningsExact 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
laxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation3ebe9191-8e0a-41cf-b759-82ecce4f50e42023-02-10WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
dg health clearlaxPOLYETHYLENE GLYCOL 3350Dolgencorp, LLC94280ce4-b2cf-451d-a660-b26ab1a2d3f02023-02-06WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
clearlaxPOLYETHYLENE GLYCOL 3350H E B0b4b752d-045d-4ff0-8e50-5607d1a841a72023-01-26WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Good Sense Clear LaxPOLYETHYLENE GLYCOL 3350L. Perrigo Company435db89c-1e32-4da5-b7d0-15e4071627152023-01-24WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC21897170-0d5e-4326-bebf-10258e0aca822022-12-08WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Equate ClearLAXPOLYETHYLENE GLYCOL 3350WALMART INC.c5c13378-3c08-415f-8ab4-8a18d6300ca82022-09-08WarningsExact 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 SolutionPSN1ccb8604-34f6-4e1e-beed-eb81d6aa7aef6
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN1ccb8604-34f6-4e1e-beed-eb81d6aa7aef6
880407polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]SBD1ccb8604-34f6-4e1e-beed-eb81d6aa7aef6
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD1ccb8604-34f6-4e1e-beed-eb81d6aa7aef6
880407ClearLax 17 GM Powder for Oral SolutionSY1ccb8604-34f6-4e1e-beed-eb81d6aa7aef6
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY1ccb8604-34f6-4e1e-beed-eb81d6aa7aef6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-499-0272288049902238 g in 1 BOTTLE (72288-499-02) 238 g2021-03-160000-00-00NoNoCurrent
72288-499-0372288049903510 g in 1 BOTTLE (72288-499-03) 510 g2020-08-260000-00-00NoNoCurrent
72288-499-0972288049909765 g in 1 BOTTLE (72288-499-09) 765 g2020-06-220000-00-00NoNoCurrent
72288-499-527228804995210 POUCH in 1 CARTON (72288-499-52) > 17 g in 1 POUCH10 pouch2020-10-190000-00-00NoNoCurrent
72288-499-7872288049978100 POUCH in 1 CARTON (72288-499-78) / 17 g in 1 POUCH100 pouch2022-05-27NoNoCurrent