FDA.reportPublic FDA data

Aqua Maris Throat

Manufacturer
JGL North America LLC
Effective date
2011-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:49:48

Label at a glance#

ProductAqua Maris Throat
Active ingredientSODIUM CHLORIDE
Label structure8 sections

Indications and uses

For alleviation of sore throat and bad breath resulting from blocked nose or salivary gland diseases For maintaining oral hygiene after surgical interventions in the oral cavity, pharynx and after tonsillectomy

Dosage and administration

Turn the dispenser into the horizontal position Direct the dispenser towards the throat and apply 3-4 dispersions 4-6 times per day The procedure can be repeated as often as required to obtain the desired result

Storage and handling

Store between 59° and 77° F (15° to 25°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Purified Sea Water 		Purpose
Relieves symptoms of sore throat

Uses

INDICATIONS & USAGE SECTION

  • For alleviation of sore throat and bad breath resulting from blocked nose or salivary gland diseases
  • For maintaining oral hygiene after surgical interventions in the oral cavity, pharynx and after tonsillectomy

Directions

OTC - WHEN USING SECTION

  • Turn the dispenser into the horizontal position
  • Direct the dispenser towards the throat and apply 3-4 dispersions 4-6 times per day
  • The procedure can be repeated as often as required to obtain the desired result

Warnings

WARNINGS SECTION

  • For external use only, do not inject
  • Do not use if seal is broken or missing

When using this product

OTC - PURPOSE SECTION

  • Use only as directed
  • Avoid contamination, do not touch tip of container to any surface
  • The use of this dispenser by more than one person may spread infection.

Other information

STORAGE AND HANDLING SECTION

Store between 59° and 77° F (15° to 25°C)

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Purified Water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Throat Spray


AQUA®
MARIS
hypertonic

Adriatic
sea water

30 mle

Carton
Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76260-105-302023-02-28C16284748780-197449f38-bfd5-f6ea-e053-dbdaa90aa703Aqua Maris Throat Drug Facts
76260-105-302019-11-13C16284748780-197449f38-bfd5-f6ea-e053-dbdaa90aa703Aqua Maris Throat Drug Facts

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 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76260-10576260-105-30

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 CHLORIDE451W47IQ8XACTIM
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
f547ffaf-592e-89fe-e053-2995a90af4355d386ab7-f2a7-410f-b6f1-9526361da8d72023-02-22WarningsExact identifier
spl set id: 5d386ab7-f2a7-410f-b6f1-9526361da8d7

Reported adverse events (FAERS/openFDA)#

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