FDA.reportPublic FDA data

Sodium Chloride

Manufacturer
Rite Aid Corporation | Akorn Operating Company LLC | Akorn
Effective date
2022-01-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:47:46

Label at a glance#

ProductSodium Chloride
Active ingredientSodium Chloride
Label structure11 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 5%

Purpose

OTC - PURPOSE SECTION

Hypertonicity Agent

Use

INDICATIONS & USAGE SECTION

  • for temporary relief of corneal edema.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • this product except under the advice and supervision of a doctor.
  • if imprinted seal is broken or missing.
  • if solution changes color or becomes cloudy.

When using this product

OTC - WHEN USING SECTION

  • temporary burning and irritation upon being instilled into eye may occur.
  • to avoid contamination, do not touch tip of container to any surface.
  • replace cap after each use.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

SPL UNCLASSIFIED SECTION

  • Store at 20° to 25°C (68° to77°F) [see USP Controlled Room Temperature].
  • Keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Boric Acid, Hypromellose 2906, Methylparaben 0.23 mg (0.023%), Propylparaben 0.1 mg (0.01%), Propylene Glycol, Sodium Borate, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH (6.0 to 8.0), and Purified Water USP.

Questions

OTC - QUESTIONS SECTION

call 1-800-579-8327

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

RITE
AID®
PHARMACY

eye care
ophthalmic
solution
sodium chloride USP 5%
hypertonicity
eye drops
Sterile
0.5 FL OZ (15 mL)

Principal Display Panel Text for Container Label:
Principal Display Panel Text for Container Label:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

RITE                      Compare to the active
AID®                     ingredient in Muro-128®*
PHARMACY         NDC 11822-5458-1
eye care
ophthalmic
solution
sodium chloride USP 5%
hypertonicity
eye drops
temporary relief
of corneal edema
doctor recommended
Sterile
0.5 FL OZ (15 mL)

Principal Display Panel Text for Carton Label:
Principal Display Panel Text for Carton Label:

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
730780sodium chloride 5 % Ophthalmic SolutionPSN4
730780sodium chloride 0.854 MEQ/ML Ophthalmic SolutionSCD4
730780NaCl 0.854 MEQ/ML Ophthalmic SolutionSY4
730780NaCl 5 % Ophthalmic SolutionSY4

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-5458-12024-01-30C16284748780-11030e365-3095-111a-e063-dadaa90a10e2c7acc338-2b84-4929-9b23-3abc35a3edcd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-5458-1Sodium Chloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
11822-5458-1Sodium Chloride1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-5458SODIUM CHLORIDE SOLUTION/ DROPS [RITE AID CORPORATION]4Legacy NDC, 2 package rows20220129_c7acc338-2b84-4929-9b23-3abc35a3edcd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X1
Sodium CationACTIVE MOIETYLYR4M0NH371
Boric AcidINACTIVE INGREDIENTR57ZHV85D41
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB1
HypromellosesINACTIVE INGREDIENT3NXW29V3WO1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
Sodium BorateINACTIVE INGREDIENT91MBZ8H3QO1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-545811822-5458-1

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
Hypromelloses3NXW29V3WOIACT
Propylene Glycol6DC9Q167V3IACT
Sodium Borate91MBZ8H3QOIACT
Sodium Hydroxide55X04QC32IIACT
Hydrochloric AcidQTT17582CBIACT
Water059QF0KO0RIACT
MethylparabenA2I8C7HI9TIACT
PropylparabenZ8IX2SC1OHIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 10 · 600 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, DELAYED RELEASE / ORAL0.25 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVENOUS78 mgExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, EMULSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INFILTRATION0.37 %w/vExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR3.6 mgExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBLOTION / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION, CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii candidate
68 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / SOFT TISSUEADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4JELLY / VAGINAL1 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOINSERT / VAGINAL54.21 mgExact identifier — unii candidate
27 equally ranked IID candidates
Sodium BorateSODIUM BORATE91MBZ8H3QOSUSPENSION/ DROPS / OPHTHALMIC0.03 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOCREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION, CONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IPOWDER / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRACAUDALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBLIQUID / ORAL4.46 mg/1mlExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / RECTALNAExact identifier — unii candidate
174 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTERIAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / ORAL9120 mgExact identifier — unii candidate
174 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBCREAM / TOPICAL38 mgExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SUBCUTANEOUS22 mgExact identifier — unii candidate
79 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii candidate
27 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBAEROSOL, METERED / RESPIRATORY (INHALATION)0.7 %w/wExact identifier — unii candidate
148 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR5 mgExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / SUBMUCOSALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii candidate
174 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / SUBCONJUNCTIVALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IFILM / BUCCAL0.09 mgExact identifier — unii candidate
174 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii candidate
27 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOGEL / RECTAL348 mgExact identifier — unii candidate
27 equally ranked IID candidates

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
19400574-c997-475d-b454-a1d3a213948dc7acc338-2b84-4929-9b23-3abc35a3edcd2022-01-27WarningsExact identifier
spl id: 19400574-c997-475d-b454-a1d3a213948d
spl set id: c7acc338-2b84-4929-9b23-3abc35a3edcd

Reported adverse events (FAERS/openFDA)#

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