Home NDC 49035-906 Mix-In Laxative Packets
Product NDC 49035-906
11-digit product format 490350906
Labeler code 49035
Product ID 49035-906_fdec012c-5f80-48fb-adf4-a32725df46cc
Type HUMAN OTC DRUG
Nonproprietary name Polyethylene Glycol 3350
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Wal-Mart Stores Inc
Application ANDA203928
Marketing category ANDA
Marketing start 2019-10-28
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 84 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 2026-08-18 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…2022-03-09 01:35 UTC 2022-03 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base Mix-In Laxative Packets
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYETHYLENE GLYCOL 3350 17 g/17g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G2M7P15E5P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 876193 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49035-906-03 Mix-In Laxative Packets 10 in 1 CARTON POWDER, FOR SOLUTION 10 9 49035-906-03 Mix-In Laxative Packets 17 g in 1 PACKET POWDER, FOR SOLUTION 17 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-906 MIX-IN LAXATIVE PACKETS (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [WAL-MART STORES INC] 8 Current NDC, Legacy NDC, 2 package rows 20250416_0347c934-1e85-4f8d-8d35-bb07f16810ad.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Strides Pharma Inc 77b9060f-c9ab-4047-b1f1-063956678453 2026-07-15 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 Mix-In Laxative Packets POLYETHYLENE GLYCOL 3350 Wal-Mart Stores Inc 0347c934-1e85-4f8d-8d35-bb07f16810ad 2026-04-10 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 ndc (product): 49035-906 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 4d524ace-9de5-4f62-9263-7cd88a36b67c 2025-10-24 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 Marketing start Marketing end Sample Exclude flag Status 49035-906-03 49035090603 10 PACKET in 1 CARTON (49035-906-03) / 17 g in 1 PACKET 10 packet 2019-10-28 0000-00-00 No No Current