What is NDC 57619-303?

57619-303 is the product NDC for Splash Tears (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 2 package NDCs, 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 Tears?

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 Tears NDC 57619-303 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)57619-303Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57619-0303Add 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
57619-303-01	57619030301	1 BOTTLE, DROPPER in 1 CARTON (57619-303-01) / 15 mL in 1 BOTTLE, DROPPERMarketed from May 13, 2020
57619-303-03	57619030303	1 BOTTLE, DROPPER in 1 CARTON (57619-303-03) / 2 mL in 1 BOTTLE, DROPPERMarketed from Jul 24, 2020 · Sample package

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 Tears
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: May 13, 2020
Listing expires: Dec 31, 2027
Identifiers: Product ID 57619-303_524658a5-3e39-2e46-e063-6294a90a48e3SPL ID 524658a5-3e39-2e46-e063-6294a90a48e3SPL set ID a58a8478-9cc5-aa39-e053-2995a90a347dRxCUI 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

N457619030301 followed by a unit qualifier and the quantity

Package 57619-0303-01. 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 May 8, 2026.

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 57619-303

What is NDC 57619-303?: 57619-303 is the product NDC for Splash Tears (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 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Splash Tears (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 Tears?: 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
Medi-First Lubricant Eye Dropscarboxymethylcellulose sodium	Carboxymethylcellulose sodium, Unspecified form .5 g/100mL	SolutionOphthalmic	Unifirst First Aid Corporation	47682-193
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
Walgreens Lubricant Eye Drops High Performance 15mL and twin packpolyethylene glycol 400, propylene glycol	Propylene glycol .3 g/100mL; Polyethylene glycol 400 .4 g/100mL	Solution/ dropsOphthalmic	Walgreen Company	0363-4549
Plus Rinse Emergency Eyewashpurified water	Water 99.1 mL/100mL	LiquidOphthalmic	INNOVATIVE SAFETY SUPPLY INC.	72598-022
Sunmark Lubricant Eye Dropspolypropylene glycol 400, propylene glycol	Polyethylene glycol 400 .4 g/100mL; Propylene glycol .3 g/100mL	Solution/ dropsOphthalmic	Strategic Sourcing Services LLC	49348-947
Refresh Digitalcarboxymethylcellulose sodium, glycerin, polysorbate 80	Carboxymethylcellulose sodium 5 mg/mL + 2 more ingredients	Solution/ dropsOphthalmic	Allergan, Inc.	0023-6952
Sodium Chloride Hypertonicity Ophthalmic Solution, 5%	Sodium chloride 50 mg/mL	Solution/ dropsOphthalmic	Reliable 1 Laboritories LLC	69618-077
Walgreens Sterile Soothing Eye Washpurified water	Water 99.05 mL/100mL	LiquidOphthalmic	Walgreens	0363-0700
Sodium Hyaluronate Eye Dropssodium hyaluronate	Sodium hyaluronate .1 g/100g	LiquidOphthalmic	Guangzhou Hechuang Commercial Service Co.,Ltd.	87298-037
Retaine CMCcarboxymethylcellulose sodium	Carboxymethylcellulose sodium, Unspecified 5 mg/mL	Solution/ dropsOphthalmic	OCuSOFT LLC	54799-460
Equate Lubricant Eye Dropscarboxymethylcellulose sodium, glycerin	Carboxymethylcellulose sodium .5 g/100mL; Glycerin .9 g/100mL	Solution/ dropsOphthalmic	Walmart	79903-365
Equate Redness and Dry Eye Reliefglycerin, naphazoline hydrochloride	Glycerin .25 g/100mL; Naphazoline hydrochloride .012 g/100mL	SolutionOphthalmic	Walmart	79903-362
Original Redness Relievertetrahydrolizine hcl	Tetrahydrozoline hydrochloride .05 g/100mL	Solution/ dropsOphthalmic	Walmart	79903-363
REFRESH Optive Mega-3carboxymethylcellulose sodium, glycerin and polysorbate 80	Carboxymethylcellulose sodium 5 mg/mL + 2 more ingredients	Solution/ dropsOphthalmic	Allergan, Inc.	0023-4230
Best Choice Artificial Tearspolyvinyl alcohol, povidone	Polyvinyl alcohol .5 g/100mL; Povidone .6 g/100mL	Solution/ dropsOphthalmic	Best Choice	63941-015
Dry Eye Reliefcarboxymethylcellulose sodium	Carboxymethylcellulose sodium, Unspecified 10 mg/mL	GelOphthalmic	CARDINAL HEALTH 110, LLC. DBA LEADER	70000-0089
Equate Lubricant Eye Dropscarboxymethylcellulose sodium	Carboxymethylcellulose sodium .5 mg/100mL	Solution/ dropsOphthalmic	Walmart	79903-364
Lubricant Dropscarboxymethylcellulose sodium	Carboxymethylcellulose sodium, Unspecified 5 mg/mL	Solution/ dropsOphthalmic	CARDINAL HEALTH 110, LLC. DBA LEADER	70000-0090
Sodium Chloride Hypertonicity Ophthalmicsodium chloride	Sodium chloride 50 mg/g	OintmentOphthalmic	Rugby Laboratories	0536-1253
Meijer Redness Relieftetrahydrozoline hci	Tetrahydrozoline hydrochloride .05 g/100mL	Solution/ dropsOphthalmic	Meijer Distribution, Inc.	41250-814

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Splash Tears (Hypromellose) NDC 57619-303