Polyethylene glycol 3350

Product NDC
55154-2328
11-digit product format
551542328
Labeler code
55154
Product ID
55154-2328_15c9cf2d-9081-443f-b408-66ac0fb27079
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA203928
Marketing category
ANDA
Marketing start
2019-06-30
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

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
A203928-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24
A203928-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24

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 UTC2026-02A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203928-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2016-08-24782e0a99824c…
2021-12-28 21:50 UTC2021-12A203928-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2016-08-24782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Polyethylene glycol 3350
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
e26457c4-03e8-430e-bfad-38ae105dbf6fAvailable 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
55154-2328-5Polyethylene glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION174
55154-2328-5Polyethylene glycol 33507 in 1 BAGPOWDER, FOR SOLUTION74

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2328POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [CARDINAL HEALTH 107, LLC]3Current NDC, Legacy NDC, 2 package rows20240210_e26457c4-03e8-430e-bfad-38ae105dbf6f.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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350The Fresh Test, LLCcb8e182f-c23f-4f8d-9c09-24e19b2e914e2026-08-05WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Polyethylene Glycol 3350INSTALAX POLYETHYLENE GLYCOL 3350Sun Pharmaceutical Industries, Inc.40bd1be7-de67-8dff-e063-6294a90aca952026-07-24WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Strides Pharma Inc77b9060f-c9ab-4047-b1f1-0639566784532026-07-15WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4e8b6a32-11ec-4419-9ec8-aaa1823899722026-06-19WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350PIONEER LIFE SCIENCES, LLC478f104a-0e50-479c-8722-a3f1eab686912026-06-11WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticalsddc9d2b1-87d8-44fa-bac6-0a7261f335642026-05-12WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Mix-In Laxative PacketsPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc0347c934-1e85-4f8d-8d35-bb07f16810ad2026-04-10WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
ez2go Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Valley Medical Products, LLCd64517d6-b0cc-4ba2-b260-e52faa8d4e782026-02-20WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350American Health Packaging81374641-e54c-4b41-a3ad-49b19a0976662026-02-18WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350GLENMARK THERAPEUTICS INC., USA5aba6bb1-d25d-4901-8e9c-4cd4a3a064712026-01-27WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Polyethylene Glycol 3350 Powder for SolutionPOLYETHYLENE GLYCOL, UNSPECIFIEDVALLEY MEDICAL PRODUCTS, LLCae595e97-6d29-44f8-a647-fcd54fcda5b12025-10-27WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4d524ace-9de5-4f62-9263-7cd88a36b67c2025-10-24WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLCe26457c4-03e8-430e-bfad-38ae105dbf6f2025-10-23WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
ndc (product): 55154-2328
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC2f5c975f-0d35-4f68-a27c-28af9a8987332025-10-23WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Kesin Pharma Corporation3729a1d2-4c98-dfdf-e063-6394a90a5a872025-06-12WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Gericare Pharmaceuticals5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd2022-10-28WarningsExact identifier
application applno (ANDA): 203928
application number: ANDA203928

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNe26457c4-03e8-430e-bfad-38ae105dbf6f4
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDe26457c4-03e8-430e-bfad-38ae105dbf6f4
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYe26457c4-03e8-430e-bfad-38ae105dbf6f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-2328-5551542328057 PACKET in 1 BAG (55154-2328-5) / 17 g in 1 PACKET7 packet2019-06-300000-00-00NoNoCurrent