MiraLAX
- Product NDC
- 76420-489
- Requested package NDC
- 76420-489-24
- 11-digit product format
- 764200489
- Labeler code
- 76420
- Product ID
- 76420-489_411a7a72-348c-4e5b-e063-6294a90a6c7e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polyethylene Glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- ASCLEMED USA INC.
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022015-001 | MIRALAX | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | RLD, RS | 2006-10-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022015-002 | MIRALAX | 17GM/PACKET | FOR SOLUTION / ORAL | RLD, RS | 2006-10-06 | 84e616aacf4f… | |
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MiraLAX
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POLYETHYLENE GLYCOL 3350 | 17 g/17g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G2M7P15E5P | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e652042f-3707-4bf6-831d-d806638b7d85 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76420-489-10 | MiraLAX | 10 in 1 CARTON | POWDER, FOR SOLUTION | 10 | 1 | |
| 76420-489-10 | MiraLAX | 17 g in 1 PACKET | POWDER, FOR SOLUTION | 17 | 1 | |
| 76420-489-20 | MiraLAX | 20 in 1 CARTON | POWDER, FOR SOLUTION | 20 | 1 | |
| 76420-489-20 | MiraLAX | 17 g in 1 POUCH | POWDER, FOR SOLUTION | 17 | 1 | |
| 76420-489-24 | MiraLAX | 24 in 1 CARTON | POWDER, FOR SOLUTION | 24 | 1 | |
| 76420-489-24 | MiraLAX | 17 g in 1 PACKET | POWDER, FOR SOLUTION | 17 | 1 | |
| 76420-489-77 | MiraLAX | 765 g in 1 BOTTLE, PLASTIC | POWDER, FOR SOLUTION | 765 | 1 | |
| 76420-489-85 | MiraLAX | 850 g in 1 BOTTLE, PLASTIC | POWDER, FOR SOLUTION | 850 | 1 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| MiraLAX | POLYETHYLENE GLYCOL 3350 | Bayer HealthCare LLC. | d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 | 2026-05-04 | Warnings | 022015 NDA022015 |
| MiraLAX | POLYETHYLENE GLYCOL 3350 | Cardinal Health 107, LLC | 1771d3bf-954d-49ea-b260-3d356e5dcfa5 | 2025-11-07 | Warnings | 022015 NDA022015 |
| MiraLAX | POLYETHYLENE GLYCOL 3350 | ASCLEMED USA INC. | e652042f-3707-4bf6-831d-d806638b7d85 | 2025-10-14 | Warnings | 022015 NDA022015 76420-489-24 76420-489 76420048924 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 876195 | MiraLAX 17 GM Powder for Oral Solution | PSN | e652042f-3707-4bf6-831d-d806638b7d85 | 1 |
| 876193 | polyethylene glycol 3350 17 GM Powder for Oral Solution | PSN | e652042f-3707-4bf6-831d-d806638b7d85 | 1 |
| 876195 | polyethylene glycol 3350 17000 MG Powder for Oral Solution [Miralax] | SBD | e652042f-3707-4bf6-831d-d806638b7d85 | 1 |
| 876193 | polyethylene glycol 3350 17000 MG Powder for Oral Solution | SCD | e652042f-3707-4bf6-831d-d806638b7d85 | 1 |
| 876195 | Miralax 17 GM Powder for Oral Solution | SY | e652042f-3707-4bf6-831d-d806638b7d85 | 1 |
| 876193 | polyethylene glycol 3350 17 GM Powder for Oral Solution | SY | e652042f-3707-4bf6-831d-d806638b7d85 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76420-489-24 | 76420048924 | 24 PACKET in 1 CARTON (76420-489-24) / 17 g in 1 PACKET | 24 packet | 2025-10-14 | No | No | Current |