Splash Pure PF
- Product NDC
- 57619-307
- 11-digit product format
- 576190307
- Labeler code
- 57619
- Product ID
- 57619-307_4485d915-c0d9-6a42-e063-6294a90a66f1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- propylene glycol
- Dosage form
- EMULSION
- Route
- OPHTHALMIC
- Labeler
- LABORATORIOS SOPHIA, S.A. DE C.V.
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-06
- Substance
- PROPYLENE GLYCOL
- Active strength
- 6 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- Splash Pure PF
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PROPYLENE GLYCOL | 6 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6DC9Q167V3 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2265162 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 40ad7ae5-1f2a-e3b1-e063-6294a90a6f84 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57619-307-01 | Splash Pure PF | 10 mL in 1 BOTTLE | EMULSION | 10 | 4 | |
| 57619-307-01 | Splash Pure PF | 1 in 1 CARTON | EMULSION | 1 | 4 |
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 |
|---|---|---|---|---|---|---|
| Visine Red Eye Total Comfort Multi-Symptom | TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORM | Kenvue Brands LLC | 5747edef-7a87-41d7-9594-6c78508b9ba2 | 2026-06-11 | Warnings | M018 |
| Nano Eye Drop Serum | WATER. SORBITOL.1.2-HEXANEDIOL GLYCERIN HYALURONATESODIUM. | Shenzhen Yiyang Zhiting Technology Co., Ltd | 539567d6-488a-9b01-e063-6394a90abece | 2026-06-06 | Warnings | M018 |
| REFRESH CELLUVISC | CARBOXYMETHYLCELLULOSE SODIUM | Allergan, Inc. | b32ed9e8-d091-4f16-b416-5a62cdfee49a | 2026-06-05 | Warnings | M018 |
| VitaPhyte Redness Reliever Lubricant Eye Drops | REDNESS RELIEVER LUBRICANT EYE DROPS | Guangzhou Liyan Cosmetics Technology Co., Ltd. | 53d4e9b0-c9a0-797a-e063-6294a90ad0cf | 2026-06-04 | Warnings | M018 |
| Rohto Digi-Eye | HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE | The Mentholatum Company | 5d6f37b9-b568-4cb6-92de-eb40779f3f8c | 2026-06-03 | Warnings | M018 |
| Visine Red Eye Hydrating Comfort Eye Drops | TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 | Savings Distributors LLC | 558178eb-1eec-af0f-e063-6394a90afad9 | 2026-06-01 | Warnings | M018 |
| C-More Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN | PROFOUND NUTRITION LIMITED | 78f04ecb-da5e-468c-81fe-70f7c26b76c2 | 2026-06-01 | Warnings | M018 |
| Peep Club | GLYCERIN | Peep Club Eyecare Corp. | 513d1988-2827-28d8-e063-6294a90a8d1f | 2026-05-28 | Warnings | M018 |
| Blink Triple Care Preservative Free | POLYETHYLENE GLYCOL 400 | Bausch & Lomb Incorporated | 65e67990-78b7-4ce9-963b-6bed3a6bed07 | 2026-05-27 | Warnings | M018 |
| Ripple | GLYCERIN, POVIDONE | CorneaCare Inc | 3b5ba197-d501-681e-e063-6294a90aefb5 | 2026-05-24 | Warnings | M018 |
| REFRESH LACRI-LUBE | MINERAL OIL, PETROLATUM | Allergan, Inc. | d232a44b-516d-4cdf-a4e7-c3a9a50dc7af | 2026-05-15 | Warnings | M018 |
| blink tears | POLYETHYLENE GLYCOL 400 | Bausch & Lomb Incorporated | f1d07347-086f-43b2-aa5f-910764fc666e | 2026-05-13 | Warnings | M018 |
| Systane Pro PF | PROPYLENE GLYCOL | Alcon Laboratories, Inc. | a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f1 | 2026-05-12 | Warnings | M018 |
| Sodium Hyaluronate Eye Drops | SODIUM HYALURONATE | Guangzhou Hechuang Commercial Service Co.,Ltd. | 5187d136-15c6-517b-e063-6294a90a811d | 2026-05-11 | Warnings | M018 |
| Splash Tears | HYPROMELLOSE | LABORATORIOS SOPHIA, S.A. DE C.V. | a58a8478-9cc5-aa39-e053-2995a90a347d | 2026-05-08 | Warnings | M018 |
| iVIZIA Lubricant Eye Gel | POVIDONE | Thea Pharma Inc. | 1f06ca1a-5270-9a82-e063-6294a90aed64 | 2026-04-29 | Warnings | M018 |
| GoodSense Eye Drops Advanced Relief Moisturizer | DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Preferred PHarmaceuticals Inc. | 011473a8-26d5-4661-b3c0-745f9b6aa1d8 | 2026-04-29 | Warnings | M018 |
| REFRESH TEARS PF | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN | Allergan, Inc. | 9e1cba7b-84ed-47f3-b19a-121992834350 | 2026-04-24 | Warnings | M018 |
| Sodium Chloride | SODIUM CHLORIDE | Method Pharmaceuticals, LLC | 4b08859e-65bd-8255-e063-6394a90af614 | 2026-04-23 | Warnings | M018 |
| Pure Eyes Sterile Eyes | NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN | SAMSON PHARMACEUTICAL | c0234e82-211f-4731-ac48-12db13b16e8a | 2026-04-21 | Warnings | M018 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2265162 | propylene glycol 0.6 % Ophthalmic Suspension | PSN | 40ad7ae5-1f2a-e3b1-e063-6294a90a6f84 | 4 |
| 2265162 | propylene glycol 6 MG/ML Ophthalmic Suspension | SCD | 40ad7ae5-1f2a-e3b1-e063-6294a90a6f84 | 4 |
| 2265162 | propylene glycol 0.6 % Ophthalmic Suspension | SY | 40ad7ae5-1f2a-e3b1-e063-6294a90a6f84 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 57619-307-01 | 57619030701 | 1 BOTTLE in 1 CARTON (57619-307-01) / 10 mL in 1 BOTTLE | 1 bottle | 2025-10-06 | No | No | Current |