FDA.reportPublic FDA data

Unither -VentureSaline Solution 0.9% Sodium Chloride

Manufacturer
Laboratoire Unither
Effective date
2025-03-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:28

Label at a glance#

ProductHYDRA NEB
Active ingredientSODIUM CHLORIDE
Label structure6 sections

Indications and uses

For dry nasal membranes

Dosage and administration

If using with an OTC ear, nose, or throat device, then follow the directions provided with the device and only use as directed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 0.9%

Purpose

OTC - PURPOSE SECTION

Moisturizer

Uses:

INDICATIONS & USAGE SECTION

For dry nasal membranes

Warnings

WARNINGS SECTION

NOT FOR INJECTION

Only use sealed vials do not use if vial is broken or already open

Keep out of reach of children
Do not use after expiration date

If you experience any adverse reaction discontinue use and call your physician

•  Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

•  Do not use 

OTC - DO NOT USE SECTION

after expiration date

  • Discontinue if you experience any adverse reaction and call your physician

Directions

DOSAGE & ADMINISTRATION SECTION

If using with an OTC ear, nose, or throat device, then follow the directions provided with the device and only use as directed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

USP Water

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HYDRA 2.5HYDRA 2.52.5 mL NDC: 43014-1111-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2709009HYDRA-NEB 0.9 % Inhalation SolutionPSN2
312997sodium chloride 0.9 % Inhalation SolutionPSN2
2709009sodium chloride 9 MG/ML Inhalation Solution [Hydra-Neb]SBD2
312997sodium chloride 9 MG/ML Inhalation SolutionSCD2
2709009Hydra-Neb 0.9 % Inhalation SolutionSY2
2709009Hydra-Neb 9 MG/ML Inhalation SolutionSY2
312997NaCl 9 MG/ML Inhalation SolutionSY2
2709009NaCl 9 MG/ML Inhalation Solution [Hydra-Neb]SY2
312997sodium chloride 0.9 % Inhalation SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
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
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct 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
43014-1111-1HYDRA NEB20 in 1 CARTONLIQUID202
43014-1111-1HYDRA NEB2.5 mL in 1 VIALLIQUID2.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43014-1111HYDRA NEB (SODIUM CHLORIDE) LIQUID [LABORATOIRE UNITHER]2Current NDC, 2 package rows20250322_30b244c0-84bb-a0a0-e063-6394a90a9dee.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43014-111143014-1111-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDRA NEBSODIUM CHLORIDELaboratoire Unither30b244c0-84bb-a0a0-e063-6394a90a9dee2025-03-19WarningsExact identifier
ndc (package): 43014-1111-1
ndc (product): 43014-1111
ndc11 (package): 43014111101
spl id: 30b34932-0838-0e54-e063-6394a90a12f9
spl set id: 30b244c0-84bb-a0a0-e063-6394a90a9dee

Reported adverse events (FAERS/openFDA)#

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