Laxative
- Product NDC
- 68016-726
- 11-digit product format
- 680160726
- Labeler code
- 68016
- Product ID
- 68016-726_ee3a5c35-858a-c36b-e053-2a95a90a0516
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- polyethylene glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Chain Drug Consortium, LLC
- Application
- ANDA090812
- Marketing category
- ANDA
- Marketing start
- 2015-06-01
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68016-726 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 68016-726 | 68016-726-08 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 68016-726 | 68016-726-17 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090812-001 | POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | e64feba35796… |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| EasyLAX | POLYETHYLENE GLYCOL 3350 | VALU MERCHANDISERS COMPANY | 6597811b-6471-5afd-e053-2991aa0a07c2 | 2025-12-16 | Warnings | 090812 ANDA090812 |
| CLEARLAX | POLYETHYLENE GLYCOL 3350 | STRATEGIC SOURCING SERVICES LLC | 041157b8-476c-e7d2-e063-6394a90ac3a0 | 2025-06-11 | Warnings | 090812 ANDA090812 |
| Polyethylene Glycol 3350, NF Powder for Solution, Laxative | POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE | Pharmaceutica North America, Inc. | d048111f-8144-4d51-a0c2-a967b2bce455 | 2025-03-04 | Warnings | 090812 ANDA090812 |
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | Bryant Ranch Prepack | 66276671-0ccd-4c32-a697-31e679fce0e3 | 2024-02-06 | Warnings | 090812 ANDA090812 |
| Polyethylene Glycol 3350, NF Powder for Solution, Laxative | POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE | LGM PHARMA SOLUTIONS, LLC | d78bead5-ff19-4d45-9003-ec131f1f5a13 | 2024-01-17 | Warnings | 090812 ANDA090812 |
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | Geri-Care Pharmaceutical Corp | f4c7eb80-d8d5-406d-90d0-9d17914d71f2 | 2022-11-24 | Warnings | 090812 ANDA090812 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68016-726-08 | 68016072608 | 238 g in 1 BOTTLE (68016-726-08) | 238 g | 2016-07-01 | 0000-00-00 | No | No | Current |
| 68016-726-17 | 68016072617 | 510 g in 1 BOTTLE (68016-726-17) | 510 g | 2016-07-01 | 0000-00-00 | No | No | Current |