Home NDC 11523-4357-2 MiraLAX
Product NDC 11523-4357
Requested package NDC 11523-4357-2
11-digit product format 115234357
Labeler code 11523
Product ID 11523-4357_51040c1b-71bf-bb83-e063-6294a90aca4e
Type HUMAN OTC DRUG
Nonproprietary name Polyethylene Glycol 3350
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Bayer HealthCare LLC.
Application NDA022015
Marketing category NDA
Marketing start 2007-02-01
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 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 N022015-001 MIRALAX POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 N022015-002 MIRALAX POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL RLD, RS 2006-10-06
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 2 · 44 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 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022015-002 MIRALAX 17GM/PACKET FOR SOLUTION / ORAL RLD, RS 2006-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022015-002 MIRALAX 17GM/PACKET FOR SOLUTION / ORAL RLD, RS 2006-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 f41ea6bd6efb…
Additional Listing Data#
Finished product Yes
Brand name base MiraLAX
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 876193 Internal RxNorm lookup 876195 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 11523-4357-1 MiraLAX 2 in 1 PACKAGE, COMBINATION POWDER, FOR SOLUTION 2 24 11523-4357-1 MiraLAX 765 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 765 24 11523-4357-2 MiraLAX 20 in 1 CARTON POWDER, FOR SOLUTION 20 24 11523-4357-2 MiraLAX 2 in 1 CARTON POWDER, FOR SOLUTION 2 24 11523-4357-3 MiraLAX 2 in 1 PACKAGE, COMBINATION POWDER, FOR SOLUTION 2 24 11523-4357-3 MiraLAX 578 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 578 24 11523-4357-5 MiraLAX 17 g in 1 PACKET POWDER, FOR SOLUTION 17 24 11523-4357-5 MiraLAX 24 in 1 CARTON POWDER, FOR SOLUTION 24 24
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-4357 MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.] 22 Current NDC, Legacy NDC, 8 package rows 20241208_d69ce3d4-7ca4-4fe3-b49e-6655e48d6963.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 · 3 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 11523-4357-2 11523435702 2 CARTON in 1 CARTON (11523-4357-2) / 20 PACKET in 1 CARTON / 17 g in 1 PACKET 2 carton 2007-02-01 0000-00-00 No No Current