MedPath

KROGER Saline

Saline Nasal Spray

Approved
Approval ID

c84b242b-f46e-4ea8-a3c1-109a47644646

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

KROGER COMPANY

DUNS: 006999528

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Nasal

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41226-759
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Nasal
Product Specifications
Route of AdministrationNASAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (7)

ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 6.5 mg in 1 mL
Code: 451W47IQ8X
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/19/2024

Saline Nasal Spray

Compare to the active ingredient in Ocean®*

NDC: 41226-759-30

Saline Nasal Spray

**+**Soothing Aloe

Sodium Chloride 0.65%

  • Instantly relieves dry nasal passages caused by sinus, cold and allergy medications and dry air
  • Gentle enough for infants
  • Relief for stuffy noses

3 FL O.Z. (89 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL AROUND CAP IS BROKEN OR MISSING.

Distributed by:

KROGER Saline Nasal Spray

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/19/2024

Uses

provides instant, soothing relief to dry irritated nasal passages due to colds, allergies, dry air, pollution, smoke, air travel and use of decongestants/steroidal sprays.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/19/2024

Drug Facts

Active Ingredients

Sodium Chloride 0.65%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/19/2024

Purpose

Moisturizer

WARNINGS SECTION

LOINC: 34071-1Updated: 1/19/2024

Warnings

**If pregnant or breast-feeding,**ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/19/2024

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/19/2024

Directions

**For children and adults,**squeeze bottle twice in each nostril as often as needed or as directed by physician.**For infants,**use drop application. Hold bottle upright for spray, horizontally for stream, and upside down for drop. The use of this dispenser by more than one person may spread infection.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 1/19/2024

Other Information

  • store at room temperature

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/19/2024

Inactive Ingredients

Aloe barbadensis leaf juice (aloe vera gel), benzalkonium chloride, benzyl alcohol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/19/2024

Questions or comments?

1-866-467-2748

*This product is not manufactured or distributed by Valeant Pharmaceuticals North America LLC, owners of the registered trademark Ocean®.

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KROGER Saline - FDA Drug Approval Details