What is NDC 57619-305?

57619-305 is the product NDC for Splash Refresh (hypromellose), Hypromellose 2910 (4000 mpa.s) .2 g/100mL solution/ drops, listed with the FDA by LABORATORIOS SOPHIA, S.A. DE C.V.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Hypromellose 2910 (4000 mpa.s).

LABORATORIOS SOPHIA, S.A. DE C.V., NDC labeler code 57619. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Splash Refresh?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Splash Refresh NDC 57619-305 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)57619-305Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57619-0305Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
57619-305-01	5761903050157619030501	1 BOTTLE, DROPPER in 1 CARTON (57619-305-01) / 15 mL in 1 BOTTLE, DROPPERMarketed from Aug 8, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Splash Refresh
Generic name (nonproprietary): hypromellose
Active ingredients: Hypromellose 2910 (4000 mpa.s) — .2 g/100mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: LABORATORIOS SOPHIA, S.A. DE C.V.NDC labeler code 57619
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 018
Marketing start: Aug 8, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 57619-305_3dd7b774-826e-4155-e063-6394a90ad5bdSPL ID 3dd7b774-826e-4155-e063-6394a90ad5bdSPL set ID 3c1c453e-2644-622a-e063-6394a90a8a94RxCUI 359634UNII RN3152OP35

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N457619030501 followed by a unit qualifier and the quantity

Package 57619-0305-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Sep 2, 2025.

Indications (excerpt from the label)

Uses Temporarily relieves burning and irritation due to dryness of the eye. discomfort due to minor irritations of the eye or to exposure to wind or sun.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57619-305

What is NDC 57619-305?: 57619-305 is the product NDC for Splash Refresh (hypromellose), Hypromellose 2910 (4000 mpa.s) .2 g/100mL solution/ drops, listed with the FDA by LABORATORIOS SOPHIA, S.A. DE C.V.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Splash Refresh (Hypromellose).
What is the active ingredient?: Hypromellose 2910 (4000 mpa.s).
Who is the labeler?: LABORATORIOS SOPHIA, S.A. DE C.V., NDC labeler code 57619. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Splash Refresh?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 018

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 018
Product	Strength	Form · route	Labeler	Product NDC
Eyewash Additive Concentratewater and propylene glycol	Water 2374.4 L/2800L; Propylene glycol 280 kg/2800L	LiquidOphthalmic	Haws Corporation	66051-236
Signature Care Lubricant Eye Drops Long Lastingpolyethylene glycol 400, propylene glycol	Polyethylene glycol 400 .4 g/100mL; Propylene glycol .3 g/100mL	SolutionOphthalmic	Better Living Brands, LLC	21130-756
Polyvinyl Alcohol	Polyvinyl alcohol 14 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-7119
Sunmark Eye Drops Advanced Moisturizer/Lubricantdextran, polyethylene glycol 400, povidone, tetrahydrozoline	Dextran 70 .1 g/100mL + 3 more ingredients	Solution/ dropsOphthalmic	Strategic Sourcing Services LLC	49348-697
Sodium Chloride	Sodium chloride 1000 mg/1	TabletOral	Rising Pharma Holdings, Inc.	57237-361
VitaPhyte Redness Reliever Lubricant Eye Dropsredness reliever lubricant eye drops	Tetrahydrozoline 5 mg/100g; Polyethylene glycol 400 1 g/100g	SolutionOphthalmic	Guangzhou Liyan Cosmetics Technology Co., Ltd.	87770-001
Signature Care Lubricant Eye Dropscarboxymethylcellulose sodium	Carboxymethylcellulose sodium .5 g/100mL	Solution/ dropsOphthalmic	Better Living Brands LLC	21130-705
Droptics Performance Eye Dropsnaphazoline hydrochloride, propylene glycol	Naphazoline hydrochloride .03 g/100mL; Propylene glycol 1 g/100mL	LiquidOphthalmic	Droptics LLC	85211-001
Signature Care Eye Drops High Performancepolyethylene glycol 400, propylene glycol	Polyethylene glycol 400 .4 g/100mL; Propylene glycol .3 g/100mL	Solution/ dropsOphthalmic	Better Living Brands LLC	21130-702
Droptics Dry Eye Reliefcarboxymethylcellulose sodium,glycerin,polysorbate 80	Carboxymethylcellulose sodium .5 g/100mL + 2 more ingredients	LiquidOphthalmic	Droptics LLC	85211-002
Gentle Eyes Lubricant Eye Dropscarboxymethylcellulose sodium	Carboxymethylcellulose sodium 5 mg/mL	Solution/ dropsOphthalmic	TRP Company	17312-430
Signature Care Eye Drops Redness and Dry Eye Reliefglycerin, naphazoline hydrochloride	Glycerin .25 g/100mL; Naphazoline hydrochloride .012 g/100mL	Solution/ dropsOphthalmic	Better Living Brands LLC	21130-703
Signature Care Eye Drops Advanced Reliefdextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl	Dextran 70 100 mg/100mL + 3 more ingredients	Solution/ dropsOphthalmic	Better Living Brands LLC	21130-704
REFRESH Optive Mega-3carboxymethylcellulose sodium, glycerin and polysorbate 80	Carboxymethylcellulose sodium 5 mg/mL + 2 more ingredients	Solution/ dropsOphthalmic	Allergan, Inc.	0023-4230
Sodium Chloride	Sodium chloride 1 g/1	TabletOral	Method Pharmaceuticals, LLC	58657-119
CVS Lubricant Eye Drops Originalpolyethylene glycol 400, propylene glycol	Polyethylene glycol 400 .4 g/100mL; Propylene glycol .3 g/100mL	SolutionOphthalmic	CVS	69842-746
Sodium Chloride Normal Saltsodium chloride	Sodium chloride 1 g/1	TabletOral	Method Pharmaceuticals	58657-118
Best Choice Eye Drops Advanced Reliefdextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride	Dextran 70 .1 g/100mL + 3 more ingredients	Solution/ dropsOphthalmic	Valu Merchandisers, Co.	63941-942
Meijer Multi-Symptom Reliefpolyethylene glycol 400, tetrahydrozoline hcl, zinc sulfate	Tetrahydrozoline hydrochloride .05 g/100mL + 2 more ingredients	Solution/ dropsOphthalmic	Meijer, Inc.	79481-0250
iVIZIA Dry Eyepovidone	Povidone 25 mg/5mL	Solution/ dropsOphthalmic	Thea Pharma Inc.	82584-700

Showing 20 of 40.

Splash Refresh (Hypromellose) NDC 57619-305