Polyethylene Glycol 3350
- Product NDC
- 87362-119
- 11-digit product format
- 873620119
- Labeler code
- 87362
- Product ID
- 87362-119_50ea60c2-f393-4ba3-bbee-7bf165de33ed
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- polyethylene glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- The Fresh Test, LLC
- Application
- ANDA203928
- Marketing category
- ANDA
- Marketing start
- 2026-07-20
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203928-001 | POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | ||
| A203928-002 | POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A203928-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2016-08-24 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A203928-002 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2016-08-24 | 4b0b4de00fa7… |
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
- Polyethylene Glycol 3350
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POLYETHYLENE GLYCOL 3350 | 17 g/17g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G2M7P15E5P | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 876193 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cb8e182f-c23f-4f8d-9c09-24e19b2e914e | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | Cardinal Health 107, LLC | 4d524ace-9de5-4f62-9263-7cd88a36b67c | 2026-08-28 | Warnings | 203928 ANDA203928 |
| Mix-In Laxative Packets | POLYETHYLENE GLYCOL 3350 | Wal-Mart Stores Inc | 0347c934-1e85-4f8d-8d35-bb07f16810ad | 2026-08-27 | Warnings | 203928 ANDA203928 |
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | The Fresh Test, LLC | cb8e182f-c23f-4f8d-9c09-24e19b2e914e | 2026-08-05 | Warnings | 203928 ANDA203928 87362-119 |
| Polyethylene Glycol 3350 | INSTALAX POLYETHYLENE GLYCOL 3350 | Sun Pharmaceutical Industries, Inc. | 40bd1be7-de67-8dff-e063-6294a90aca95 | 2026-07-24 | Warnings | 203928 ANDA203928 |
| Polyethylene glycol 3350 | POLYETHYLENE GLYCOL 3350 | Cardinal Health 107, LLC | 4e8b6a32-11ec-4419-9ec8-aaa182389972 | 2026-06-19 | Warnings | 203928 ANDA203928 |
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | PIONEER LIFE SCIENCES, LLC | 478f104a-0e50-479c-8722-a3f1eab68691 | 2026-06-11 | Warnings | 203928 ANDA203928 |
| Polyethylene glycol 3350 | POLYETHYLENE GLYCOL 3350 | Major Pharmaceuticals | ddc9d2b1-87d8-44fa-bac6-0a7261f33564 | 2026-05-12 | Warnings | 203928 ANDA203928 |
| ez2go Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | Valley Medical Products, LLC | d64517d6-b0cc-4ba2-b260-e52faa8d4e78 | 2026-02-20 | Warnings | 203928 ANDA203928 |
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | American Health Packaging | 81374641-e54c-4b41-a3ad-49b19a097666 | 2026-02-18 | Warnings | 203928 ANDA203928 |
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | GLENMARK THERAPEUTICS INC., USA | 5aba6bb1-d25d-4901-8e9c-4cd4a3a06471 | 2026-01-27 | Warnings | 203928 ANDA203928 |
| Polyethylene Glycol 3350 Powder for Solution | POLYETHYLENE GLYCOL, UNSPECIFIED | VALLEY MEDICAL PRODUCTS, LLC | ae595e97-6d29-44f8-a647-fcd54fcda5b1 | 2025-10-27 | Warnings | 203928 ANDA203928 |
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | Kesin Pharma Corporation | 3729a1d2-4c98-dfdf-e063-6394a90a5a87 | 2025-06-12 | Warnings | 203928 ANDA203928 |
| Polyethylene Glycol 3350 | POLYETHYLENE GLYCOL 3350 | Gericare Pharmaceuticals | 5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd | 2022-10-28 | Warnings | 203928 ANDA203928 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87362-119-01 | 87362011901 | 119 g in 1 CAN (87362-119-01) | 119 g | 2026-07-20 | No | No | Current |