Home NDC 55316-306 healthy accents clear lax
Product NDC 55316-306
11-digit product format 553160306
Labeler code 55316
Product ID 55316-306_e5fb4227-dab9-422a-a186-b454899f674c
Type HUMAN OTC DRUG
Nonproprietary name Polyethylene Glycol 3350
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler DZA Brands LLC
Application ANDA090685
Marketing category ANDA
Marketing start 2009-11-06
Marketing end 2020-05-31
Substance POLYETHYLENE GLYCOL 3350
Active strength 17 g/17g
NDC exclude flag No
Listing certified through 0000-00-00
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 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090685-001 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 A090685-002 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 782e0a99824c…
DailyMed Socrata Ingredients# 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 · 51 matching rows.