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 |
|---|---|---|---|---|---|---|
| TheraTears | CARBOXYMETHYLCELLULOSE SODIUM | MEDTECH PRODUCTS INC | 17a01236-130f-495b-9f8d-92b6a23b2dc5 | 2026-09-09 | Warnings | M018 |
| Leader Eye Drops Redness Relief | GLYCERIN, NAPHAZOLINE HYDROCHLORIDE | Cardinal Health | aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a | 2026-09-09 | Warnings | M018 |
| Leader Artificial Tears 15 mL | POLYVINYL ALCOHOL, POVIDONE | Cardinal Health | 8cccc589-3a8e-baad-e053-2a95a90ab8c7 | 2026-09-09 | Warnings | M018 |
| Clear Eyes Nighttime | GLYCERIN | Prestige Brands Holdings, Inc. | af75e2f7-81dd-43e0-a390-b52bbfbebf62 | 2026-09-08 | Warnings | M018 |
| FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS | POVIDONE, POLYVINYL ALCOHOL SOLUTION | Harrow Eye, LLC | 049e9cc9-0663-53bc-e063-6294a90a2c4f | 2026-09-04 | Warnings | M018 |
| Dr.Harry EYES PROTECTION | POLYETHYLENE GLYCOL 400 1% EYES PROTECTION | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5a9fe033-89d3-da62-e063-6294a90a4503 | 2026-09-03 | Warnings | M018 |
| REFRESH LIQUIGEL | CARBOXYMETHYLCELLULOSE SODIUM | Allergan, Inc. | 4b8b2f6a-4b89-446c-9e5b-9b83c453a01d | 2026-08-28 | Warnings | M018 |
| Rohto Optic Glow | NAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOL | The Mentholatum Company | df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff | 2026-08-20 | Warnings | M018 |
| Rohto All-In-One | HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE | The Mentholatum Company | 43e690e4-b381-46e3-838c-33aef5bdadde | 2026-08-20 | Warnings | M018 |
| Rohto Max Strength | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 | The Mentholatum Company | e4b49550-1ca3-4bd7-854d-409b53fa5e26 | 2026-08-20 | Warnings | M018 |
| Sodium Chloride | SODIUM CHLORIDE | YYBA CORP | 597f3347-647c-3545-e063-6294a90abab2 | 2026-08-20 | Warnings | M018 |
| Mineral Oil/White Petrolatum | MINERAL OIL/WHITE PETROLATUM | YYBA CORP | 5967ef02-6770-bfd7-e063-6294a90a7904 | 2026-08-19 | Warnings | M018 |
| Rohto Preservative Free Dry Aid | POVIDONE, PROPYLENE GLYCOL | The Mentholatum Company | f4b1974c-2412-45f6-b79d-88b8a0bcb608 | 2026-08-18 | Warnings | M018 |
| Rohto Dry-Aid | POVIDONE, PROPYLENE GLYCOL | The Mentholatum Company | 8ea5c6c9-48f4-406a-a2cb-9280c546d87d | 2026-08-18 | Warnings | M018 |
| Leader Dry Eye Relief Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | CARDINAL HEALTH 110, LLC. DBA LEADER | 2ded4bda-b3c3-4521-8701-5c8446fd148b | 2026-08-17 | Warnings | M018 |
| Mineral Oil/White Petrolatum | MINERAL OIL/WHITE PETROLATUM | YYBA CORP | 5905b300-6f1f-a61f-e063-6394a90a1123 | 2026-08-14 | Warnings | M018 |
| SYSTANE HYDRATION PF PRESERVATIVE FREE | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 8936f66f-10fe-44ab-a26e-dd8b05dfa997 | 2026-08-10 | Warnings | M018 |
| Dr. Shitong Photon Energy Eye Care Liquid | TETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUID | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 58ace434-55ef-17ef-e063-6294a90aa878 | 2026-08-10 | Warnings | M018 |
| Systane Pro PF | PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 23b3515f-fbe5-4398-b2df-8b2eccdd01e2 | 2026-08-10 | Warnings | M018 |
| Leader Lubricant Eye Drops 30ct | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | CARDINAL HEALTH 110, LLC. DBA LEADER | 8df69f2c-40c4-245c-e053-2a95a90a5406 | 2026-08-05 | 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 |