FDA.reportPublic FDA data

Sodium Chloride Inhalation Solution

Manufacturer
Nephron Pharmaceuticals Corporation
Effective date
2014-09-17
Label type
MEDICAL DEVICE
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:59

Label at a glance#

ProductSodium Chloride
Active ingredientSodium Chloride
Label structure3 sections

Label contents#

Full prescribing information#

Sodium Chloride Inhalation Solution, USP 3%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0487-9003-60

Sodium Chloride
Inhalation Solution, USP 3%

Sterile, Preservative-free, Non-pyrogenic
FOR RESPIRATORY THERAPY
NOT FOR INJECTION

Rx Only
60 x 4 mL Sterile Unit-Dose Vials

Manufactured By:
nephron
pharmaceuticals
corporation
Orlando, FL 32811

For Customer Service,
Call 1-800-443-4313

Each single-use vial contains 4ml sterile, preservative-free, non-pyrogenic Sodium Chloride Solution 3% for respiratory therapy.

INDICATIONS: To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.

WARNING: Not for injection or parenteral administration.

DIRECTIONS FOR USE: Hold vial gently twist and pull off top. Invert and squeeze to dispense prescribed volume.

Discard any unused solution of this single-use vial and any unused solution remaining in the nebulizer cup.

HOW SUPPLIED: Single-use plastic vials containing 4ml solution in cartons of 60 vials.

NDC# 0487-9003-60

STORAGE: Store at room temperature 15° to 30° C (59° to 86° F). Avoid excessive heat and protect from freezing.

CAUTION: Rx Only

Please Recycle

IC 441
Rev. 12-20-11

Sodium Chloride Inhalation Solution, USP 3%
Sodium Chloride Inhalation Solution, USP 3%

Sodium Chloride Inhalation Solution, USP 7%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0487-9007-60

Sodium Chloride
Inhalation Solution, USP 7%

Sterile, Preservative-free, Non-pyrogenic
FOR RESPIRATORY THERAPY
NOT FOR INJECTION

Rx Only
60 x 4 mL Sterile Unit-Dose Vials

Manufactured By:
nephron
pharmaceuticals
corporation
Orlando, FL 32811

For Customer Service,
Call 1-800-443-4313

Each single-use vial contains 4ml sterile, preservative-free, non-pyrogenic Sodium Chloride Solution 7% for respiratory therapy.

INDICATIONS: To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.

WARNING: Not for injection or parenteral administration.

DIRECTIONS FOR USE: Hold vial gently twist and pull off top. Invert and squeeze to dispense prescribed volume.

Discard any unused solution of this single-use vial and any unused solution remaining in the nebulizer cup.

HOW SUPPLIED: Single-use plastic vials containing 4ml solution in cartons of 60 vials.

NDC# 0487-9007-60

STORAGE: Store at room temperature 15° to 30° C (59° to 86° F). Avoid excessive heat and protect from freezing.

CAUTION: Rx Only

Please Recycle

IC 442
Rev. 12-20-11

Sodium Chloride Inhalation Solution, USP 7%
Sodium Chloride Inhalation Solution, USP 7%

Sodium Chloride Inhalation Solution, USP 10%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0487-9010-60

Sodium Chloride
Inhalation Solution, USP 10%

Sterile, Preservative-free, Non-pyrogenic
FOR RESPIRATORY THERAPY
NOT FOR INJECTION

Rx Only
60 x 4 mL Sterile Unit-Dose Vials

Manufactured By:
nephron
pharmaceuticals
corporation
Orlando, FL 32811

For Customer Service,
Call 1-800-443-4313

Each single-use vial contains 4ml sterile, preservative-free, non-pyrogenic Sodium Chloride Solution 10% for respiratory therapy.

INDICATIONS: To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.

WARNING: Not for injection or parenteral administration.

DIRECTIONS FOR USE: Hold vial gently twist and pull off top. Invert and squeeze to dispense prescribed volume.

Discard any unused solution of this single-use vial and any unused solution remaining in the nebulizer cup.

HOW SUPPLIED: Single-use plastic vials containing 4ml solution in cartons of 60 vials.

NDC# 0487-9010-60

STORAGE: Store at room temperature 15° to 30° C (59° to 86° F). Avoid excessive heat and protect from freezing.

CAUTION: Rx Only

Please Recycle

IC 443
Rev. 12-20-11

Sodium Chloride Inhalation Solution, USP 10%
Sodium Chloride Inhalation Solution, USP 10%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
724592sodium chloride 10 % Inhalation SolutionPSN1
724590sodium chloride 3 % Inhalation SolutionPSN1
706943sodium chloride 7 % Inhalation SolutionPSN1
724592sodium chloride 100 MG/ML Inhalation SolutionSCD1
724590sodium chloride 30 MG/ML Inhalation SolutionSCD1
706943sodium chloride 70 MG/ML Inhalation SolutionSCD1
724592NaCl 10 % Inhalation SolutionSY1
724592NaCl 100 MG/ML Inhalation SolutionSY1
724590NaCl 30 MG/ML Inhalation SolutionSY1
706943NaCl 70 MG/ML Inhalation SolutionSY1
724590sodium chloride 3 % Inhalation SolutionSY1
706943sodium chloride 7 % Inhalation SolutionSY1

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
0487-9003-60Sodium Chloride60 in 1 CARTON601
0487-9003-60Sodium Chloride4 mL in 1 VIAL, SINGLE-USE41
0487-9007-60Sodium Chloride60 in 1 CARTONSOLUTION601
0487-9007-60Sodium Chloride4 mL in 1 VIAL, SINGLE-USESOLUTION41
0487-9010-60Sodium Chloride60 in 1 CARTONSOLUTION601
0487-9010-60Sodium Chloride4 mL in 1 VIAL, SINGLE-USESOLUTION41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0487-9003SODIUM CHLORIDE () SODIUM CHLORIDE () SOLUTION SODIUM CHLORIDE () SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]12 package rows20140922_34375b61-0af7-4ed9-8bdb-0538ecc9068c.zip
0487-9007SODIUM CHLORIDE () SODIUM CHLORIDE () SOLUTION SODIUM CHLORIDE () SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]12 package rows20140922_34375b61-0af7-4ed9-8bdb-0538ecc9068c.zip
0487-9010SODIUM CHLORIDE () SODIUM CHLORIDE () SOLUTION SODIUM CHLORIDE () SOLUTION [NEPHRON PHARMACEUTICALS CORPORATION]12 package rows20140922_34375b61-0af7-4ed9-8bdb-0538ecc9068c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0487-9003-60ML - Milliliter0487-9003c0cf3e7c-5f4c-46e3-a11a-474f96434eeb12014-10-03
0487-9007-60ML - Milliliter0487-9007be5296ad-f449-43a5-a870-739b92e227a912014-10-03
0487-9010-60ML - Milliliter0487-901000da6a82-a099-433a-93ff-b7f06ca8cf2c12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X1
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0487-90030487-9003-60
0487-90070487-9007-60
0487-90100487-9010-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium Chloride451W47IQ8XACTIB
Water059QF0KO0RIACT
Sodium Chloride451W47IQ8XACTIB
Water059QF0KO0RIACT
Sodium Chloride451W47IQ8XACTIB
Water059QF0KO0RIACT

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 9 · 176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsName fallback
brand name: Sodium Chloride
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsName fallback
brand name: Sodium Chloride
generic name: SODIUM CHLORIDE
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsName fallback
generic name: SODIUM CHLORIDE
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsName fallback
brand name: Sodium Chloride
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsName fallback
brand name: Sodium Chloride
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsName fallback
brand name: Sodium Chloride
generic name: SODIUM CHLORIDE
WHWSWB 0.9% SalineSODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd4e9c21e5-f2f9-90e4-e063-6394a90acfe22026-07-11WarningsName fallback
generic name: SODIUM CHLORIDE
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsName fallback
generic name: SODIUM CHLORIDE
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsName fallback
generic name: SODIUM CHLORIDE
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC107af8bc-b6af-4b85-8c8a-ea757dcef1da2026-06-12Adverse reactionsName fallback
brand name: Sodium Chloride
generic name: SODIUM CHLORIDE
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsName fallback
brand name: Sodium Chloride
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsName fallback
brand name: Sodium Chloride
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsName fallback
brand name: Sodium Chloride
generic name: SODIUM CHLORIDE
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsName fallback
generic name: SODIUM CHLORIDE
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEHanlim4ee80e16-1bb1-8238-e063-6294a90aa7192026-04-04WarningsName fallback
generic name: SODIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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