Home NDC 0363-0306 smooth lax
Product NDC 0363-0306
11-digit product format 003630306
Labeler code 0363
Product ID 0363-0306_c677ed05-f149-4430-baba-d65b43cd1828
Type HUMAN OTC DRUG
Nonproprietary name Polyethylene Glycol 3350
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Walgreen Company
Application ANDA090685
Marketing category ANDA
Marketing start 2009-10-09
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 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 · 24 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…
Additional Listing Data#
Finished product Yes
Brand name base smooth lax
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 0363-0306-00 smooth lax 17 g in 1 POUCH POWDER, FOR SOLUTION 17 17 0363-0306-01 smooth lax 119 g in 1 BOTTLE POWDER, FOR SOLUTION 119 17 0363-0306-02 smooth lax 238 g in 1 BOTTLE POWDER, FOR SOLUTION 238 17 0363-0306-03 smooth lax 510 g in 1 BOTTLE POWDER, FOR SOLUTION 510 17 0363-0306-04 smooth lax 850 g in 1 BOTTLE POWDER, FOR SOLUTION 850 17 0363-0306-09 smooth lax 765 g in 1 BOTTLE POWDER, FOR SOLUTION 765 17 0363-0306-10 smooth lax 612 g in 1 BOTTLE POWDER, FOR SOLUTION 612 17 0363-0306-19 smooth lax 595 g in 1 BOTTLE POWDER, FOR SOLUTION 595 17 0363-0306-52 smooth lax 10 in 1 CARTON POWDER, FOR SOLUTION 10 17 0363-0306-60 smooth lax 20 in 1 CARTON POWDER, FOR SOLUTION 20 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0306 SMOOTH LAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [WALGREEN COMPANY] 15 Current NDC, Legacy NDC, 10 package rows 20241217_3027af65-2f7f-472d-83f5-254d5d75013c.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 3 · 51 matching rows.
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 0363-0306-00 00363030600 17 g in 1 POUCH (0363-0306-00) 17 g 2010-04-27 0000-00-00 No No Current 0363-0306-01 00363030601 119 g in 1 BOTTLE (0363-0306-01) 119 g 2015-04-10 0000-00-00 No No Current 0363-0306-02 00363030602 238 g in 1 BOTTLE (0363-0306-02) 238 g 2009-10-09 0000-00-00 No No Current 0363-0306-03 00363030603 510 g in 1 BOTTLE (0363-0306-03) 510 g 2009-10-09 0000-00-00 No No Current 0363-0306-04 00363030604 850 g in 1 BOTTLE 850 g Historical 0363-0306-09 00363030609 765 g in 1 BOTTLE (0363-0306-09) 765 g 2015-04-10 0000-00-00 No No Current 0363-0306-10 00363030610 612 g in 1 BOTTLE (0363-0306-10) 612 g 2015-04-16 0000-00-00 No No Current 0363-0306-19 00363030619 595 g in 1 BOTTLE (0363-0306-19) 595 g 2024-12-14 No No Current 0363-0306-52 00363030652 10 POUCH in 1 CARTON (0363-0306-52) / 17 g in 1 POUCH (0363-0306-00) 10 pouch 2010-04-27 0000-00-00 No No Current 0363-0306-60 00363030660 20 POUCH in 1 CARTON (0363-0306-60) / 17 g in 1 POUCH (0363-0306-00) 20 pouch 2019-05-28 0000-00-00 No No Current