Home NDC 67091-447 Winco
Product NDC 67091-447
11-digit product format 670910447
Labeler code 67091
Product ID 67091-447_57a2d3da-388a-437e-9ea3-9e3aef12a0df
Type HUMAN OTC DRUG
Nonproprietary name Polyethylene Glycol 3350
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler WINCO FOODS
Application ANDA202071
Marketing category ANDA
Marketing start 2023-08-21
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 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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 67091-447-08 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 67091-447-08 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 67091-447-08 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 67091-447-08 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 67091-447-08 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 67091-447-08 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 67091-447-08 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202071-001 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28
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 2 · 41 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 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202071-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2012-12-28 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Winco
Listing expiration 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67091-447-08 Winco 238 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 238 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-447 WINCO (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [WINCO FOODS] 3 Current NDC, 1 package rows 20250411_d649f758-a46f-4864-8718-878ee5a74bfc.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67091-447-08 67091044708 238 g in 1 BOTTLE, PLASTIC (67091-447-08) 238 g 2023-08-21 No No Current