FDA.reportPublic FDA data

Polyethylene Glycol 3350

Product NDC
69230-324
11-digit product format
692300324
Labeler code
69230
Product ID
69230-324_336b962c-a4b5-746b-e063-6294a90a5040
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA214990
Marketing category
ANDA
Marketing start
2021-04-14
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
A214990-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14
A214990-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2021-04-14

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214990-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2021-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214990-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2021-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-144b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214990-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2021-04-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214990-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2021-04-14a50c72e98297…

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
b321a7f5-f80b-4a51-9fd9-2c21fc1cae9bAvailable 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
69230-324-32Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION176
69230-324-32Polyethylene Glycol 33507 in 1 CARTONPOWDER, FOR SOLUTION76
69230-324-33Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION176
69230-324-33Polyethylene Glycol 335010 in 1 CARTONPOWDER, FOR SOLUTION106
69230-324-34Polyethylene Glycol 3350119 g in 1 BOTTLEPOWDER, FOR SOLUTION1196
69230-324-35Polyethylene Glycol 3350238 g in 1 BOTTLEPOWDER, FOR SOLUTION2386
69230-324-36Polyethylene Glycol 3350510 g in 1 BOTTLEPOWDER, FOR SOLUTION5106
69230-324-37Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION176
69230-324-37Polyethylene Glycol 335014 in 1 CARTONPOWDER, FOR SOLUTION146
69230-324-38Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION176
69230-324-38Polyethylene Glycol 3350100 in 1 CARTONPOWDER, FOR SOLUTION1006
69230-324-39Polyethylene Glycol 3350765 g in 1 BOTTLEPOWDER, FOR SOLUTION7656
69230-324-40Polyethylene Glycol 335017 g in 1 PACKETPOWDER, FOR SOLUTION176
69230-324-40Polyethylene Glycol 335040 in 1 CARTONPOWDER, FOR SOLUTION406

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-324-31EA - Each69230-3246b545476-064b-479c-a021-33e4f665133812022-09-12
69230-324-34GM - Gram69230-324c16e8114-c8bc-45c6-ac87-b200865b092b12021-10-08
69230-324-35GM - Gram69230-3244dcbf22b-99ee-44ff-adb6-30b2a1a1cb6412023-02-06
69230-324-36GM - Gram69230-3244aa04cb6-0185-4471-8258-00f0590be1f612023-02-06
69230-324-37EA - Each69230-324932d74e2-628d-4099-8ada-2539f6bd4c8012023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-324POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CAMBER CONSUMER CARE INC]6Current NDC, Legacy NDC, 14 package rows20250424_b321a7f5-f80b-4a51-9fd9-2c21fc1cae9b.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350YYBA Corp48488531-5d04-4af6-e063-6294a90afe4b2026-01-13WarningsExact identifier
application applno (ANDA): 214990
application number: ANDA214990
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals Inc.cccbe459-813d-4668-8cd2-76be82906a322025-09-09WarningsExact identifier
application applno (ANDA): 214990
application number: ANDA214990
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Camber Consumer Care Incb321a7f5-f80b-4a51-9fd9-2c21fc1cae9b2025-04-23WarningsExact identifier
application applno (ANDA): 214990
application number: ANDA214990
ndc (product): 69230-324
Polyethylene Gycol 3350POLYETHYLENE GYCOL 3350Allegiant Health13851c9a-a226-481b-9db5-bc7053997df72025-03-17WarningsExact identifier
application applno (ANDA): 214990
application number: ANDA214990
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350CHAIN DRUG MARKETING ASSOCIATION, INC.901a1918-87bb-47c2-a465-8c468c3a1ee52024-03-26WarningsExact identifier
application applno (ANDA): 214990
application number: ANDA214990
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350BluePoint Laboratories02e36812-53c2-003b-e063-6394a90aed122024-01-31WarningsExact identifier
application applno (ANDA): 214990
application number: ANDA214990

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNb321a7f5-f80b-4a51-9fd9-2c21fc1cae9b6
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDb321a7f5-f80b-4a51-9fd9-2c21fc1cae9b6
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYb321a7f5-f80b-4a51-9fd9-2c21fc1cae9b6
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNcccbe459-813d-4668-8cd2-76be82906a322
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDcccbe459-813d-4668-8cd2-76be82906a322
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYcccbe459-813d-4668-8cd2-76be82906a322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-324-32692300324327 PACKET in 1 CARTON (69230-324-32) / 17 g in 1 PACKET7 packet2021-04-140000-00-00NoNoCurrent
69230-324-336923003243310 PACKET in 1 CARTON (69230-324-33) / 17 g in 1 PACKET10 packet2021-04-140000-00-00NoNoCurrent
69230-324-3469230032434119 g in 1 BOTTLE (69230-324-34) 119 g2021-04-140000-00-00NoNoCurrent
69230-324-3569230032435238 g in 1 BOTTLE (69230-324-35) 238 g2021-04-14NoNoCurrent
69230-324-3669230032436510 g in 1 BOTTLE (69230-324-36) 510 g2021-04-14NoNoCurrent
69230-324-376923003243714 PACKET in 1 CARTON (69230-324-37) / 17 g in 1 PACKET14 packet2021-04-14NoNoCurrent
69230-324-3869230032438100 PACKET in 1 CARTON (69230-324-38) / 17 g in 1 PACKET100 packet2025-04-21NoNoCurrent
69230-324-3969230032439765 g in 1 BOTTLE (69230-324-39) 765 g2025-01-03NoNoCurrent
69230-324-406923003244040 PACKET in 1 CARTON (69230-324-40) / 17 g in 1 PACKET40 packet2025-04-21NoNoCurrent