FDA.reportPublic FDA data

ENTSOL ® SPRAY Buffered Hypertonic Saline Nasal Spray

Manufacturer
PharmaDerm, A division of Fougera Pharmaceuticals Inc.
Effective date
2012-04-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:47:24

Label at a glance#

ProductENTSOL
Active ingredientSODIUM CHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Recommended by leading ENTs, Allergists, and Pediatricians for fastacting, temporary relief...to enhance ciliary flow...as a pre-treatment for nasal steroid use. Reliable uniformity of dosage, buffered hypertonic saline nasal spray under pressure. Washes away allergens, dust, dirt and pollens.

Improves breathing. Clears congestion. Helps reduce nasal swelling. Helps relieve symptoms of sinusitis, allergies/ rhinitis, headaches, congestion, postnasal drip, and coughs due to postnasal drip. Effective treatment for preand post-surgical care. Pre-treatment for nasal steroid use.

Directions:

For best results, keep spray can in vertical position during use. Insert nozzle in one nostril. Lightly press down on applicator with finger to create spray.Repeat same procedure in other nostril. Spray 2 to 6 times daily or as instructed by a physician. Wipe nozzle clean after each use.

Ingredients:

Purified Water, Sodium Chloride, Sodium Phosphate - Dibasic, Potassium Phosphate - Monobasic.

Caution:

Contents under pressure. Do not dent or puncture can. Keep out of direct sunlight. Store and use at room temperature, between 15°- 30°C (59°-86°F). Please properly dispose of the container when the propellant is depleted. Note: It is not unusual that some liquid might remain in the container after all of the propellant is depleted. Use at room temperature only. Do not use if nose is completely blocked. Avoid oral consumption.

No CFCs - Environment Friendly

IL 133B R10/11

AN0795 0004

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Sodium chloride (3%)

Purpose:

OTC - PURPOSE SECTION

Moisturizer

INDICATIONS & USAGE SECTION

Uses:

  • wash away allergens, dust, dirt & pollens
  • increse ciliary flow
  • improve breathing
  • clear congestion
  • help reduce nasal swelling

WARNINGS SECTION

Warnings:

  • Use at room temperature only
  • Do not use if nose is completely blocked
  • Avoid oral consumption

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Important - Keep container in vertical position during use. Insert nozzle in one nostril.
  • Lightly press down on applicator with finger.
  • Repeat the same in other nostril.
  • Spray 2 to 6 times daily or as instructed by a physician.
  • Wipe nozzle clean after each use.

SPL UNCLASSIFIED SECTION

Other information:

  • Contents under air pressure. Do not dent or puncture container.
  • Keep container out of direct sunlight.
  • Store at room temperature, 15° - 30°C (59° and 86°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Sodium Phosphate - Dibasic, Potassium Phosphate - Monobasic.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

CARTON SEALED FOR YOUR PROTECTION.

SPL UNCLASSIFIED SECTION

Manufactured for

PharmaDerm®

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747 USA

www.pharmaderm.com

Manufactured by:

Laboratoires Chemineau

Vouvray, France

CE

0459

IC 142B R11/11

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10337-311-10

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – LABEL
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – LABEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10337-311-10

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10337-311-102024-08-27C16284748780-19d75b9d0-3f88-f424-e053-dadaa90a57ceENTSOL ® SPRAY Buffered Hypertonic Saline Nasal Spray
10337-311-102020-01-31C16284748780-19d75b9d0-3f88-f424-e053-dadaa90a57ceENTSOL ® SPRAY Buffered Hypertonic Saline Nasal Spray

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10337-311-10ML - Milliliter10337-311396ab365-8c22-4d6f-bb96-63be48899fee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL511
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA741
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10337-31110337-311-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 33 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SYRUP / ORAL19 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS40 mgExact identifier — unii candidate
14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SUSPENSION / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION / INTRA-ARTICULAR0.3 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74SYRUP / ORAL70 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / INTRAVENOUS200 mgExact identifier — unii candidate
14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51CAPSULE, DELAYED RELEASE PELLETS / ORAL272 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74SOLUTION / ORAL40 mg/1mlExact identifier — unii candidate
14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74CREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION, SOLUTION / INTRAVESICAL29.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS110 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SOLUTION / OPHTHALMIC0.2 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51TABLET / ORAL25 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION / INTRAMUSCULAR0.3 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION / SUBCUTANEOUS8 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51CAPSULE, COATED PELLETS / ORAL272 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SPRAY / NASAL3 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SOLUTION / ORAL287 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SOLUTION / AURICULAR (OTIC)0.2 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74SUSPENSION / OPHTHALMIC0.43 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SOLUTION / NASAL680 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74FILM, SOLUBLE / ORAL9 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74CONCENTRATE / ORAL17 mg/5mlExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51SUSPENSION / ORAL50 mg/5mlExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION, SOLUTION / INTRAVENOUS1.36 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS2.98 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / INTRADERMAL0.2 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74TABLET, EXTENDED RELEASE / ORAL143 mgExact identifier — unii candidate
14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASICMONOBASIC POTASSIUM PHOSPHATE4J9FJ0HL51INJECTION / INTRAVENOUS68 mgExact identifier — unii candidate
19 equally ranked IID candidates

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
1df8476e-2479-401f-8c2f-1408f8338bc89ecb95a8-f5e6-477b-b040-747c77513ace2012-04-25WarningsExact identifier
spl set id: 9ecb95a8-f5e6-477b-b040-747c77513ace

Reported adverse events (FAERS/openFDA)#

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