FDA.reportPublic FDA data

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 table
IngredientStrength
PROPYLENE GLYCOL6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6DC9Q167V3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2265162Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
40ad7ae5-1f2a-e3b1-e063-6294a90a6f84Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57619-307-01Splash Pure PF10 mL in 1 BOTTLEEMULSION104
57619-307-01Splash Pure PF1 in 1 CARTONEMULSION14

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.

Matched openFDA labels page 21 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Discount Drug Mart Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.31a98e6c-42df-6b56-e063-6294a90a35642024-01-01WarningsExact identifier
application number: M018
Harris Teeter Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLHarris Teeter, LLC.31ac6883-ffc6-39de-e063-6294a90a52dd2024-01-01WarningsExact identifier
application number: M018
Exchange Select High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArmy and Air Force Exchange Service31ac8bd2-c2e9-6f2c-e063-6394a90adc722024-01-01WarningsExact identifier
application number: M018
CVS Health Fast Acting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVS Pharmacy, Inc.31addfd2-52f2-05b3-e063-6294a90a337f2024-01-01WarningsExact identifier
application number: M018
Equate Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Wal-Mart Stores, Inc.91fb8fb5-b871-4535-e053-2995a90a9b162023-12-23WarningsExact identifier
application number: M018
Equate Lubricant Eye Drops Preservative-FreeCARBOXYMETHYLCELLULOSE SODIUMWal-Mart Stores, Inc.9228a39b-38d2-1dfc-e053-2a95a90a3c902023-12-23WarningsExact identifier
application number: M018
Equate Restore Plus Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMWalmart, Inc.9e665ca2-4fa6-fdb4-e053-2a95a90abcca2023-12-23WarningsExact identifier
application number: M018
Sunmark Eye Drops Advanced Moisturizer/LubricantDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINEStrategic Sourcing Services LLC0daa4e39-0447-44b6-a7d7-370b12bf94512023-12-23WarningsExact identifier
application number: M018
Equate Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWal-Mart Stores, Inc.91f85a72-5270-e4db-e053-2995a90aeb212023-12-23WarningsExact identifier
application number: M018
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWal-Mart Stores, Inc.e32233ef-ea15-45b8-8e83-b658cf4c56a02023-12-23WarningsExact identifier
application number: M018
Sunmark Eye Drops Original FormulaTETRAHYDROZOLINE HCLStrategic Sourcing Services LLC33efa7e9-4c3a-4d72-af31-c5e35095c2ff2023-12-23WarningsExact identifier
application number: M018
Sunmark Lubricant Eye DropsPOLYPROPYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCb117ff0a-1a48-4022-96e6-52bc45f056fc2023-12-23WarningsExact identifier
application number: M018
Sunmark Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC043ccc34-44ee-416a-88bc-f247774e90752023-12-23WarningsExact identifier
application number: M018
Sunmark Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC58f0b6d7-6072-40fd-ba72-b3ed688347912023-12-23WarningsExact identifier
application number: M018
Leader Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMCardinal Health8d9a4eec-bf0e-6c3b-e053-2995a90ae9aa2023-12-23WarningsExact identifier
application number: M018
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
application number: M018
Good Neighbor Pharmacy Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMAmerisource Bergen Drug Corp.fd2dc23f-6ccc-2644-e053-6294a90a889e2023-12-23WarningsExact identifier
application number: M018
Rite Aid Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Rite Aid Corporationfa1b5b66-9643-e9a7-e053-6394a90ae3cf2023-12-23WarningsExact identifier
application number: M018
Signature Care Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands, LLC05a63929-fccd-2936-e063-6294a90aeac52023-12-23WarningsExact identifier
application number: M018
Meijer Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.9feadde4-fbe5-0c9e-e053-2995a90a9b302023-12-22WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2265162propylene glycol 0.6 % Ophthalmic SuspensionPSN40ad7ae5-1f2a-e3b1-e063-6294a90a6f844
2265162propylene glycol 6 MG/ML Ophthalmic SuspensionSCD40ad7ae5-1f2a-e3b1-e063-6294a90a6f844
2265162propylene glycol 0.6 % Ophthalmic SuspensionSY40ad7ae5-1f2a-e3b1-e063-6294a90a6f844

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57619-307-01576190307011 BOTTLE in 1 CARTON (57619-307-01) / 10 mL in 1 BOTTLE1 bottle2025-10-06NoNoCurrent