kirkland signature laxaclear

Product NDC
63981-306
11-digit product format
639810306
Labeler code
63981
Product ID
63981-306_a4db35f7-8e2f-43f7-9d00-db11631fe31e
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Costco Wholesale Company
Application
ANDA090685
Marketing category
ANDA
Marketing start
2009-11-07
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
2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63981-30663981-306-03DDiscontinued by firm2026-09-14
excluded packagepackage63981-30663981-306-07DDiscontinued by firm2026-09-14

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0563981-306-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0563981-306-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2663981-306-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2663981-306-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3163981-306-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3163981-306-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2863981-306-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2863981-306-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2163981-306-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2163981-306-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1063981-306-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1063981-306-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3163981-306-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3163981-306-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2063981-306-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2063981-306-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1063981-306-070efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1063981-306-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0863981-306-07ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0863981-306-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0363981-306-07367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0363981-306-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0963981-306-07557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0963981-306-03557ba5c1ecfa…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…

Additional Listing Data#

Finished product
Yes
Brand name base
kirkland signature laxaclear
Brand name suffix
original prescription strength
Listing expiration
2026-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f58fa5c0-8ab7-4427-aea0-d536b47acbb5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63981-306-03kirkland signature laxaclearoriginal prescription strength510 g in 1 BOTTLEPOWDER, FOR SOLUTION51010
63981-306-04kirkland signature laxaclearoriginal prescription strength850 g in 1 BOTTLEPOWDER, FOR SOLUTION85010
63981-306-07kirkland signature laxaclearoriginal prescription strength3 in 1 PACKAGEPOWDER, FOR SOLUTION310
63981-306-07kirkland signature laxaclearoriginal prescription strength510 g in 1 BOTTLEPOWDER, FOR SOLUTION51010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-306-04GM - Gram63981-306ef89720b-e9ec-4a4a-a8a0-928bc534f0f012017-07-07
63981-306-07GM - Gram63981-306579b0ef9-6e8b-4816-a0a7-0bb11c42cc3712013-03-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-306KIRKLAND SIGNATURE LAXACLEAR ORIGINAL PRESCRIPTION STRENGTH (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [COSTCO WHOLESALE COMPANY]9Current NDC, Legacy NDC, 4 package rows20221217_f58fa5c0-8ab7-4427-aea0-d536b47acbb5.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 1 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacyfc3b6006-a75a-41b3-9f0b-a3152df1363f2026-09-04WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC1ccb8604-34f6-4e1e-beed-eb81d6aa7aef2026-09-03WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2026-09-02WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
gentle laxPOLYETHYLENE GLYCOL 3350Kroger Company0d820dcc-440a-4036-86e9-fdb30cac95732026-09-01WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLCbd33463b-eb1a-41ed-92d1-f50d0923eb3b2026-08-31WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
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
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
ndc (product): 63981-306

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNf58fa5c0-8ab7-4427-aea0-d536b47acbb510
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDf58fa5c0-8ab7-4427-aea0-d536b47acbb510
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYf58fa5c0-8ab7-4427-aea0-d536b47acbb510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-306-0363981030603510 g in 1 BOTTLE (63981-306-03) 510 g2011-01-240000-00-00NoNoCurrent
63981-306-0463981030604850 g in 1 BOTTLE (63981-306-04) 850 g2009-11-070000-00-00NoNoCurrent
63981-306-07639810306073 BOTTLE in 1 PACKAGE (63981-306-07) > 510 g in 1 BOTTLE3 bottle2011-01-240000-00-00NoNoCurrent