Home NDC 63940-762 Polyethylene Glycol
Product NDC 63940-762
11-digit product format 639400762
Labeler code 63940
Product ID 63940-762_6b9592f2-983d-462f-90a2-c288bc8f6657
Type HUMAN OTC DRUG
Nonproprietary name Polyethylene Glycol
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Harmon Stores, Inc
Application ANDA203928
Marketing category ANDA
Marketing start 2016-08-24
Marketing end 0000-00-00
Substance POLYETHYLENE GLYCOL 3350
Active strength 17 g/17g
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203928-001 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 A203928-002 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24
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 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 74a2ff9319b5…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63940-762-03 Polyethylene Glycol 119 g in 1 BOTTLE POWDER, FOR SOLUTION 119 1 63940-762-04 Polyethylene Glycol 238 g in 1 BOTTLE POWDER, FOR SOLUTION 238 1 63940-762-05 Polyethylene Glycol 510 g in 1 BOTTLE POWDER, FOR SOLUTION 510 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63940-762 POLYETHYLENE GLYCOL POWDER, FOR SOLUTION [HARMON STORES, INC] 1 Legacy NDC, 3 package rows 20170522_3fd415b7-3d17-47ff-86b1-9eeac5f20271.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 · 15 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Cardinal Health 107, LLC 4d524ace-9de5-4f62-9263-7cd88a36b67c 2026-08-28 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Mix-In Laxative Packets POLYETHYLENE GLYCOL 3350 Wal-Mart Stores Inc 0347c934-1e85-4f8d-8d35-bb07f16810ad 2026-08-27 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 The Fresh Test, LLC cb8e182f-c23f-4f8d-9c09-24e19b2e914e 2026-08-05 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 INSTALAX POLYETHYLENE GLYCOL 3350 Sun Pharmaceutical Industries, Inc. 40bd1be7-de67-8dff-e063-6294a90aca95 2026-07-24 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene glycol 3350 POLYETHYLENE GLYCOL 3350 Cardinal Health 107, LLC 4e8b6a32-11ec-4419-9ec8-aaa182389972 2026-06-19 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 PIONEER LIFE SCIENCES, LLC 478f104a-0e50-479c-8722-a3f1eab68691 2026-06-11 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene glycol 3350 POLYETHYLENE GLYCOL 3350 Major Pharmaceuticals ddc9d2b1-87d8-44fa-bac6-0a7261f33564 2026-05-12 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 ez2go Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Valley Medical Products, LLC d64517d6-b0cc-4ba2-b260-e52faa8d4e78 2026-02-20 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 American Health Packaging 81374641-e54c-4b41-a3ad-49b19a097666 2026-02-18 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 GLENMARK THERAPEUTICS INC., USA 5aba6bb1-d25d-4901-8e9c-4cd4a3a06471 2026-01-27 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 Powder for Solution POLYETHYLENE GLYCOL, UNSPECIFIED VALLEY MEDICAL PRODUCTS, LLC ae595e97-6d29-44f8-a647-fcd54fcda5b1 2025-10-27 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene glycol 3350 POLYETHYLENE GLYCOL 3350 Cardinal Health 107, LLC e26457c4-03e8-430e-bfad-38ae105dbf6f 2025-10-23 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene glycol 3350 POLYETHYLENE GLYCOL 3350 Cardinal Health 107, LLC 2f5c975f-0d35-4f68-a27c-28af9a898733 2025-10-23 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Kesin Pharma Corporation 3729a1d2-4c98-dfdf-e063-6394a90a5a87 2025-06-12 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Gericare Pharmaceuticals 5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd 2022-10-28 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 63940-762-03 63940076203 119 g in 1 BOTTLE 119 g Historical 63940-762-04 63940076204 238 g in 1 BOTTLE 238 g Historical 63940-762-05 63940076205 510 g in 1 BOTTLE 510 g Historical