SKY PEG3350
- Product NDC
- 63739-198
- 11-digit product format
- 637390198
- Labeler code
- 63739
- Product ID
- 63739-198_79c20e03-f175-4502-81b1-58d833ca4ec9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polyethylene Glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- McKesson Corporation dba SKY Packaging
- Application
- ANDA090685
- Marketing category
- ANDA
- Marketing start
- 2020-06-08
- 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 | 63739-198 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 63739-198 | 63739-198-61 | D | Discontinued by firm | 2026-10-15 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090685-001 | POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | ||
| A090685-002 | POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090685-001 | POLYETHYLENE GLYCOL 3350 | 17GM/PACKET | FOR SOLUTION / ORAL | 2009-10-06 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090685-002 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-06 | 4b0b4de00fa7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63739-198-61 | EA - Each | 63739-198 | 9d4122e2-b105-4f04-8962-daaa5073e761 | 1 | 2020-08-06 |
| 63739-198-62 | EA - Each | 63739-198 | af5ba0f8-5d17-47ba-95a9-9bf0f99ff714 | 1 | 2020-08-06 |
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 |
|---|---|---|---|---|---|---|
| injoy constipation relief | POLYETHYLENE GLYCOL 3350 | L. Perrigo Company | b2414517-04bf-4f29-951e-b867855078c3 | 2022-08-19 | Warnings | 090685 ANDA090685 |
| Good Sense Clear Lax | POLYETHYLENE GLYCOL 3350 | Proficient Rx LP | 0858a914-4812-4e4d-82f8-ecf93d43ef3b | 2022-07-01 | Warnings | 090685 ANDA090685 |
| signature care clearlax | POLYETHYLENE GLYCOL 3350 | Safeway | 91d2e780-2aae-411c-b7b3-820302f0f63e | 2021-05-13 | Warnings | 090685 ANDA090685 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63739-198-61 | 63739019861 | 30 POUCH in 1 CARTON (63739-198-61) > 17 g in 1 POUCH (63739-198-62) | 30 pouch | 2020-06-08 | 0000-00-00 | No | No | Current |