FDA.reportPublic FDA data

Kids Nasal Allergy Relief

Manufacturer
Similasan AG
Effective date
2021-04-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:13

Label at a glance#

ProductKids Nasal Allergy Relief
Active ingredientCARDIOSPERMUM HALICACABUM FLOWERING TOP, GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT, SCHOENOCAULON OFFICINALE SEED
Label structure10 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as: • allergies accompanied by runny nose, itching and/or burning of the nose, watery eyes, sneezing and swollen mucous membranes (congestion) • post nasal drip caused by allergies • sinus pressure caused by allergies

Dosage and administration

For adults and children ages 2 and over: • Remove tamper-evident plastic seal from bottle • Lift cap off bottle • Spray 1-3 times into each nostril • Use as needed • Replace cap after use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Cardiospermum 6X

Galphimia glauca 6X

Luffa operculata 6X

Sabadilla 6X

Purpose

OTC - PURPOSE SECTION

itching, runny nose

runny nose, watery eyes, sneezing

runny nose, sinus congestion

sneezing, itching

Uses*

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:

• allergies accompanied by runny nose, itching and/or burning of the nose, watery eyes, sneezing and swollen mucous membranes (congestion)

• post nasal drip caused by allergies

• sinus pressure caused by allergies

Warnings

WARNINGS SECTION

  • Children under 2 years of age should be seen by a physician.
  • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
  • Replace cap tightly after every use.
  • To avoid contamination, do not touch the tip of the container to any surface besides nose.
  • Discard open bottle after 6 months.
  • The use of this container by more than one person may spread infection.

If pregnant, trying to get pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Ask a doctor before use if you:

OTC - ASK DOCTOR SECTION

• are susceptible to nose bleeds

• are prone to ear, nose or throat sensitivity

Stop use and ask a doctor if:

OTC - STOP USE SECTION

• symptoms worsen or persist for more than 72 hours

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children ages 2 and over:

• Remove tamper-evident plastic seal from bottle

• Lift cap off bottle

• Spray 1-3 times into each nostril

• Use as needed

• Replace cap after use

Other information

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Sodium chloride

Questions?

OTC - QUESTIONS SECTION

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Kids Nasal
Allergy
Relief
20 ml/ 0.68 fl oz

PRINCIPAL DISPLAY PANEL Kids Nasal Allergy Relief 20 ml/ 0.68 fl ozPRINCIPAL DISPLAY PANEL Kids Nasal Allergy Relief 20 ml/ 0.68 fl oz

PRINCIPAL DISPLAY PANEL Kids Nasal Allergy Relief 20 ml/ 0.68 fl ozPRINCIPAL DISPLAY PANEL Kids Nasal Allergy Relief 20 ml/ 0.68 fl oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-245-202025-01-30C16284748780-12cef2736-5ac8-d83d-e063-dadaa90ab31fKids Nasal Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-245-20Kids Nasal Allergy Relief20 mL in 1 BOTTLE, SPRAYSPRAY202
53799-245-20Kids Nasal Allergy Relief1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-245KIDS NASAL ALLERGY RELIEF (CARDIOSPERMUM HALICACABUM FLOWERING TOP, GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT AND SCHOENOCAULON OFFICINALE SEED) SPRAY [SIMILASAN AG]2Legacy NDC, 2 package rows20230106_56a56fcb-e420-4db0-86bd-184bdd081636.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53799-24553799-245-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARDIOSPERMUM HALICACABUM FLOWERING TOPMZP2508BRRACTIB
GALPHIMIA GLAUCA FLOWERING TOP93PH5Q8M7EACTIB
LUFFA OPERCULATA FRUITC4MO6809HUACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT

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
57bf80df-3d41-45bc-9e70-febf2f6e157a56a56fcb-e420-4db0-86bd-184bdd0816362021-04-23WarningsExact identifier
spl id: 57bf80df-3d41-45bc-9e70-febf2f6e157a
spl set id: 56a56fcb-e420-4db0-86bd-184bdd081636

Reported adverse events (FAERS/openFDA)#

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