Home DailyMed d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 MiraLAX Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Bayer HealthCare LLC.
Effective date 2026-05-04
Label type HUMAN OTC DRUG LABEL
Version 24
Source full-release
Hydrated at 2026-06-01 01:55:59 Label at a glance# Product MiraLAX
Active ingredient POLYETHYLENE GLYCOL 3350
Label structure 16 sections
Dosage and administration do not take more than directed unless advised by your doctor the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap) adults and children 17 years of age and older: use once a day fill to top of white section in cap which is marked to indicate the correct dose (17 g) stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperat...
Storage and handling store at 20°-25°C (68°-77°F) tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 876195 MiraLAX 17 GM Powder for Oral Solution PSN 24 876193 polyethylene glycol 3350 17 GM Powder for Oral Solution PSN 24 876195 polyethylene glycol 3350 17000 MG Powder for Oral Solution [Miralax] SBD 24 876193 polyethylene glycol 3350 17000 MG Powder for Oral Solution SCD 24 876195 Miralax 17 GM Powder for Oral Solution SY 24 876193 polyethylene glycol 3350 17 GM Powder for Oral Solution SY 24
DailyMed Pharmacologic Classes# Product Linked Resources# 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 11523-4357-1 MiraLAX 765 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 765 24 11523-4357-1 MiraLAX 2 in 1 PACKAGE, COMBINATION POWDER, FOR SOLUTION 2 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 578 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 578 24 11523-4357-3 MiraLAX 2 in 1 PACKAGE, COMBINATION POWDER, FOR SOLUTION 2 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 11523-7234-1 MiraLAX 17 g in 1 PACKET POWDER, FOR SOLUTION 17 24 11523-7234-2 MiraLAX 119 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 119 24 11523-7234-3 MiraLAX 238 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 238 24 11523-7234-4 MiraLAX 510 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 510 24 11523-7234-5 MiraLAX 12 in 1 CARTON POWDER, FOR SOLUTION 12 24 11523-7234-5 MiraLAX 17 g in 1 PACKET POWDER, FOR SOLUTION 17 24 11523-7234-6 MiraLAX 17 g in 1 PACKET POWDER, FOR SOLUTION 17 24 11523-7234-9 MiraLAX 510 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 510 24 11523-7234-9 MiraLAX 2 in 1 CELLO PACK POWDER, FOR SOLUTION 2 24 11523-7268-3 MiraLAX 17 g in 1 PACKET POWDER, FOR SOLUTION 17 24 11523-7268-3 MiraLAX 10 in 1 CARTON POWDER, FOR SOLUTION 10 24 11523-7268-4 MiraLAX 765 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 765 24 11523-7268-5 MiraLAX 850 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 850 24 11523-7268-7 MiraLAX 17 g in 1 PACKET POWDER, FOR SOLUTION 17 24 11523-7268-7 MiraLAX 5 in 1 CARTON POWDER, FOR SOLUTION 5 24 11523-7268-8 MiraLAX 17 g in 1 PACKET POWDER, FOR SOLUTION 17 24 11523-7268-8 MiraLAX 24 in 1 CARTON POWDER, FOR SOLUTION 24 24 11523-7268-9 MiraLAX 20 in 1 CARTON POWDER, FOR SOLUTION 20 24 11523-7268-9 MiraLAX 17 g in 1 POUCH POWDER, FOR SOLUTION 17 24 11523-7341-1 MiraLAX 612 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 612 24 11523-7341-2 MiraLAX 3 in 1 CARTON POWDER, FOR SOLUTION 3 24 11523-7341-2 MiraLAX 17 g in 1 PACKET POWDER, FOR SOLUTION 17 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII SPL version Uploaded Polyethylene Glycol 3350 ACTIVE INGREDIENT G2M7P15E5P 9 Polyethylene Glycol 3350 ACTIVE MOIETY G2M7P15E5P 9
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 2 matching rows.
MiraLAX Polyethylene Glycol 3350 NDC Codes# Product NDC, Package NDC table Product NDC Package NDC 11523-7268 11523-7268-3 , 11523-7268-8 , 11523-7268-7 , 11523-7268-4 , 11523-7268-9 , 11523-7268-5 11523-7234 11523-7234-1 , 11523-7234-2 , 11523-7234-3 , 11523-7234-4 , 11523-7234-5 , 11523-7234-6 , 11523-7234-9 11523-7341 11523-7341-1 , 11523-7341-2 11523-4357 11523-4357-1 , 11523-4357-3 , 11523-4357-5 , 11523-4357-2
Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 4 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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 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 · 46 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 N022015-001 MIRALAX 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022015-002 MIRALAX 17GM/PACKET FOR SOLUTION / ORAL RLD, RS 2006-10-06 caaa826d4ba7…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…
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