FDA.reportPublic FDA data

Saline Ampoules

Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Effective date
2025-10-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:39:00

Label at a glance#

ProductSaline Ampoules
Active ingredientSODIUM CHLORIDE
Label structure14 sections

Dosage and administration

For Adults and children 4 years and older. Use as often as needed. Children under 4 years of age consult a doctor. Hold vial gently and twist top off Squeeze vial to dispense Discard after use

Storage and handling

Store at controlled room temperature 20º-25ºC (68º-77ºF) and protect from sunlight and sources of heat. See bottom of carton for Lot No. and Expiration data No Bacteriostatic or other preservatives added

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 0.9%

Purpose

OTC - PURPOSE SECTION

Moisturizer

INDICATIONS & USAGE SECTION

This product may be used for conditions in the respiratory passages, nasal cavity or as directed by your healthcare provider.

Warnings

WARNINGS SECTION

For External Use Only

Not for parenteral administration

When using this product

OTC - WHEN USING SECTION

When using this product a mild and temporary irritation may be experienced at the beginning of use.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a doctor before use.

Do Not Use

OTC - DO NOT USE SECTION

  • Same applicator on more than one individual
  • If sensitive to any of the components

Directions

DOSAGE & ADMINISTRATION SECTION

For Adults and children 4 years and older. Use as often as needed.

Children under 4 years of age consult a doctor.

Hold vial gently and twist top off

Squeeze vial to dispense

Discard after use

Other information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 20º-25ºC (68º-77ºF) and protect from sunlight and sources of heat.
  • See bottom of carton for Lot No. and Expiration data
  • No Bacteriostatic or other preservatives added

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Distributed By

SPL UNCLASSIFIED SECTION

Distributed By

Enjoy Good Health

15900 La Cantera Pkwy Ste 20210

San Antonio, TX 78256

Questions: support@enjoygoodhealth.com

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Single Use Saline Physiological 5ml 093025 CDER 2Single Use Saline Physiological 5ml 093025 CDER 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
351179sodium chloride 0.9 % Nasal SprayPSN3
351179sodium chloride 9 MG/ML Nasal SpraySCD3
351179NaCl 9 MG/ML Nasal SpraySY3
351179sodium chloride 0.9 % Nasal SpraySY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130764613934663GTIN-13: 0764613934663
EAN-13: 0764613934663
GTIN-12: 764613934663
UPC-A: 764613934663
GTIN storage (14 digits): 00764613934663		Single Use Saline Physiological 5ml 093025 CDER 2.jpg

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
69396-116-05Saline Ampoules5 mL in 1 VIALSPRAY53
69396-116-05Saline Ampoules60 in 1 CARTONSPRAY603

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-11669396-116-05

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
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12022-11-22full-release2026-06-01 01:15:53

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
Saline AmpoulesSODIUM CHLORIDE 0.9%Trifecta Pharmaceuticals USA, LLC.ee18ef7c-bb5d-30ec-e053-2a95a90a964e2025-10-13WarningsExact identifier
ndc (package): 69396-116-05
ndc (product): 69396-116
ndc11 (package): 69396011605
spl id: 410d90c1-c459-8577-e063-6394a90a8254
spl set id: ee18ef7c-bb5d-30ec-e053-2a95a90a964e

Reported adverse events (FAERS/openFDA)#

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