Home NDC 55154-5035 MiraLAX
Product NDC 55154-5035
11-digit product format 551545035
Labeler code 55154
Product ID 55154-5035_a30d3776-09c8-41aa-9282-ba2486632e07
Type HUMAN OTC DRUG
Nonproprietary name Polyethylene Glycol 3350
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Cardinal Health 107, LLC
Application NDA022015
Marketing category NDA
Marketing start 2009-02-23
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 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…
Additional Listing Data#
Finished product Yes
Brand name base MiraLAX
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 · 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 55154-5035-6 MiraLAX 6 in 1 BAG POWDER, FOR SOLUTION 6 17 55154-5035-6 MiraLAX 17 g in 1 PACKET POWDER, FOR SOLUTION 17 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-5035 MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CARDINAL HEALTH 107, LLC] 16 Current NDC, Legacy NDC, 2 package rows 20250305_1771d3bf-954d-49ea-b260-3d356e5dcfa5.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 55154-5035-6 55154503506 6 PACKET in 1 BAG (55154-5035-6) / 17 g in 1 PACKET 6 packet 2009-02-23 0000-00-00 No No Current