PURIFIED WATER
- Product NDC
- 54799-565
- 11-digit product format
- 547990565
- Labeler code
- 54799
- Product ID
- 54799-565_c432aeb1-0e26-4893-98b0-7a225a040f26
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- PURIFIED WATER
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- OCuSOFT, Inc.
- Application
- part349
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2009-01-01
- Marketing end
- 2022-05-31
- Substance
- WATER
- Active strength
- 99 mL/100mL
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 54799-565 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 54799-565 | 54799-565-01 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 54799-565 | 54799-565-59 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 54799-565-59 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 54799-565-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 54799-565-59 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 54799-565-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 54799-565-59 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 54799-565-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 54799-565-59 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 54799-565-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 54799-565-59 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 54799-565-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 54799-565-59 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 54799-565-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 54799-565-59 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 54799-565-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 54799-565-59 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 54799-565-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 54799-565-59 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 54799-565-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 54799-565-59 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 54799-565-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 54799-565-59 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 54799-565-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 54799-565-59 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 54799-565-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|
| 54799-565-01 | ML - Milliliter | 54799-565 | cd949bad-7fe4-4815-99a3-7a4aceedd623 | 1 | 2013-12-02 |
| 54799-565-59 | ML - Milliliter | 54799-565 | 00bcef7c-24a4-4120-a3d2-5797d7b3e9e1 | 1 | 2013-12-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Water | ACTIVE INGREDIENT | 059QF0KO0R | PURIFIED WATER (PURIFIED WATER) SOLUTION/ DROPS [OCUSOFT, INC.] | 1 | |
| Water | ACTIVE MOIETY | 059QF0KO0R | PURIFIED WATER (PURIFIED WATER) SOLUTION/ DROPS [OCUSOFT, INC.] | 1 | |
| Benzalkonium Chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | PURIFIED WATER (PURIFIED WATER) SOLUTION/ DROPS [OCUSOFT, INC.] | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | PURIFIED WATER (PURIFIED WATER) SOLUTION/ DROPS [OCUSOFT, INC.] | 1 | |
| Potassium Chloride | INACTIVE INGREDIENT | 660YQ98I10 | PURIFIED WATER (PURIFIED WATER) SOLUTION/ DROPS [OCUSOFT, INC.] | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | PURIFIED WATER (PURIFIED WATER) SOLUTION/ DROPS [OCUSOFT, INC.] | 1 | |
| Sodium Phosphate, Dibasic, Anhydrous | INACTIVE INGREDIENT | 22ADO53M6F | PURIFIED WATER (PURIFIED WATER) SOLUTION/ DROPS [OCUSOFT, INC.] | 1 | |
| Sodium Phosphate, Monobasic | INACTIVE INGREDIENT | 3980JIH2SW | PURIFIED WATER (PURIFIED WATER) SOLUTION/ DROPS [OCUSOFT, INC.] | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54799-565-01 | 54799056501 | 30 mL in 1 BOTTLE, DROPPER (54799-565-01) | 30 ml | 2009-01-01 | 0000-00-00 | No | No | Current |
| 54799-565-59 | 54799056559 | 118 mL in 1 BOTTLE, DROPPER (54799-565-59) | 118 ml | 2009-01-01 | 0000-00-00 | No | No | Current |