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
Ingredient	Strength
PROPYLENE GLYCOL	6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6DC9Q167V3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
40ad7ae5-1f2a-e3b1-e063-6294a90a6f84	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
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.

Matched openFDA labels page 17 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eyesaline Eyewash Concentrate	PURIFIED WATER	Honeywell Safety Products, Inc.	2d90c8e8-f479-3535-e063-6394a90af122	2025-02-07	Warnings	Exact identifier application number: M018
Code Red Eye Drops Redness Relief	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL	4 Trees, LLC	0aa08018-cc2d-d947-e063-6394a90a914a	2025-02-07	Warnings	Exact identifier application number: M018
Tyson 2.0 Mike Red Eye Drops For Dry High Eyes	GLYCERIN, NAPHAZOLINE HCL	Jbrands Pharma L.L.C.	288e9c85-0562-89bf-e063-6394a90a110d	2025-02-07	Warnings	Exact identifier application number: M018
Sodium Chloride Normal Salt	SODIUM CHLORIDE	Citragen Pharmaceuticals Inc	aae783b2-18fe-69ca-e053-2a95a90a0800	2025-01-30	Warnings	Exact identifier application number: M018
Sodium Chloride Normal Salt	SODIUM CHLORIDE	Citragen Pharmaceuticals Inc	82c29f1d-a018-7483-e053-2a91aa0a8f7e	2025-01-30	Warnings	Exact identifier application number: M018
OASIS Tears Lubricant Eye	GLYCERIN	OASIS Medical, Inc.	00071697-4ac6-4962-8eee-388b8b52bd40	2025-01-22	Warnings	Exact identifier application number: M018
ImproVue Lubricant	HYPROMELLOSE 2208 (15000 MPA.S)	Oculus Surgical, Inc.	63b82129-4848-47c5-bf92-ec4b1a9e9974	2025-01-22	Warnings	Exact identifier application number: M018
VISCO SHIELD Lubricant	HYPROMELLOSE 2208 (15000 MPA.S)	OASIS Medical, Inc.	72d22610-d8ab-4f24-b304-8b013430a7d7	2025-01-22	Warnings	Exact identifier application number: M018
OASIS Tears Plus Preservative-Free Lubricant Eye	GLYCERIN	OASIS Medical, Inc.	ea931c0f-c61e-4771-84f1-0274b1c3e28e	2025-01-22	Warnings	Exact identifier application number: M018
Medics Choice Soothing Eye Wash	PURIFIED WATER	KC Pharmaceuticals, Inc.	10e49808-161e-f4ec-e063-6294a90a1775	2025-01-19	Warnings	Exact identifier application number: M018
Sodium Chloride Hypertonicity Ophthalmic Solution, 5%	SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%	Reliable 1 Laboritories LLC	29175c17-223e-5e92-e063-6294a90a71d2	2025-01-15	Warnings	Exact identifier application number: M018
Lubricating Tears	CARBOXYMETHYLCELLULOSE SODIUM 0.5% SOLUTION	Reliable 1 Laboritories LLC	29023a57-eba3-4241-e063-6294a90a7048	2025-01-15	Warnings	Exact identifier application number: M018
Aurodone Povidone Iodine 5 % Opthalmic Solution	POVIDONE IODINE 5 % TOPICAL SOLUTION	Aurolab	f3444446-1dad-79ff-e053-2a95a90af411	2025-01-06	Warnings	Exact identifier application number: M018
Hypromellose Eye Drops 0.7%	HYPROMELLOSE EYE DROPS 0.7%	Aurolab	d35313d0-b190-5fb0-e053-2a95a90a5283	2025-01-02	Warnings	Exact identifier application number: M018
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 ml	PROPYLENE GLYCOL	Red Wedding LLC	b2c2fd0f-b944-6b0b-e053-2995a90aa216	2025-01-01	Warnings	Exact identifier application number: M018
Rite Aid Hydration Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Rite Aid Corporation	ecac1351-e944-21da-e053-2995a90a6d34	2024-12-31	Warnings	Exact identifier application number: M018
Lubricant Eye PM	MINERAL OIL, WHITE PETROLATUM	Reliable 1 Laboratories LLC	baec8045-97fe-6f60-e053-2a95a90a050e	2024-12-31	Warnings	Exact identifier application number: M018
Lil Drug Store Eye Drops Redness Reliever	TETRAHYDROZOLINE HYDROCHLORIDE	Lil Drug Store Products, Inc	d2a47e98-a04c-47ec-aded-d1c894f040e2	2024-12-30	Warnings	Exact identifier application number: M018
Rain Renewal Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Rain Eye Drops, LLC	af7a5768-7d1d-3d93-e053-2a95a90a38f6	2024-12-29	Warnings	Exact identifier application number: M018
Glitch Advanced Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL	Misemer Pharmaceutical, Inc	03778509-3374-2168-e063-6294a90a9505	2024-12-23	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6DC9Q167V3	PROPYLENE GLYCOL	57-55-6	PROPYLENE GLYCOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
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