FDA.reportPublic FDA data

Sodium Chloride Hypertonicity Ophthalmic Solution, 5%

Manufacturer
Reliable 1 Laboritories LLC
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:54

Label at a glance#

ProductSodium Chloride Hypertonicity Ophthalmic Solution, 5%
Active ingredientSODIUM CHLORIDE
Label structure12 sections

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a doctor.

Label contents#

Full prescribing information#

Active ingredient & purpose

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

Active ingredient

Sodium chloride 5%

OTC - PURPOSE SECTION

Hypertonicity agent

USE

INDICATIONS & USAGE SECTION

temporary relief of corneal edema

WARNINGS

WARNINGS SECTION

For external use only

Save box for complete information

When using this product

OTC - WHEN USING SECTION

When using this product

  • keep tightly closed
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after use
  • this product may cause temporary burning and irritation on being instilled into the eye.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

  • you experience eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a doctor.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information

  • replace cap after using, and keep tightly closed
  • store upright at 15–30 °C (59–86 °F)
  • remove contact lenses before using

INACTIVE INGREDIENT SECTION

Boric Acid, Hypromellose Methylparaben, Propylene Glycol, Proplyparaben, purified water and sodium Borate, Sodium Hydroxide, and/or Hydrochloric Acid maybe added to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-516-341-0666

8:30AM-4:30PM

Monday – Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 696180-077-55

Reliable 1 Laboratories

Temporary relief of corneal edema

Compare to Muro 128® active ingredient*

Sodium Chloride Hypertonicity Ophthalmic Solution, 5%

Sterile

0.5 fl oz (15mL)

*This product is not manufactured by Bausch & Lomb, the owner of the registered trademark Muro 128®

Distributed by

Reliable 1 Laboratories LLC

Valley Stream, NY 11580

Reliable1labs.com

Sodium Chloride bottle LabelSodium Chloride bottle Label

carton labelcarton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
730780sodium chloride 5 % Ophthalmic SolutionPSN2
730780sodium chloride 0.854 MEQ/ML Ophthalmic SolutionSCD2
730780NaCl 0.854 MEQ/ML Ophthalmic SolutionSY2
730780NaCl 5 % Ophthalmic SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-077-55Sodium Chloride Hypertonicity Ophthalmic Solution, 5%1 in 1 CARTONSOLUTION/ DROPS12
69618-077-55Sodium Chloride Hypertonicity Ophthalmic Solution, 5%15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-077SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5% SOLUTION/ DROPS [RELIABLE 1 LABORITORIES LLC]2Current NDC, 2 package rows20250213_29175c17-223e-5e92-e063-6294a90a71d2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-077-55ML - Milliliter69618-0776046d206-70e0-4578-8e02-5f282ad13a4512025-01-14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-07769618-077-55

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB
BORIC ACIDR57ZHV85D4IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Chloride Hypertonicity Ophthalmic Solution, 5%SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%Reliable 1 Laboritories LLC29175c17-223e-5e92-e063-6294a90a71d22025-01-15WarningsExact identifier
ndc (package): 69618-077-55
ndc (product): 69618-077
ndc11 (package): 69618007755
spl id: 2bc84e6b-f871-1be7-e063-6294a90ac878
spl set id: 29175c17-223e-5e92-e063-6294a90a71d2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.