childrens allergy relief — Spray, Metered

Overview

Brand name

childrens allergy relief

Generic name

Fluticasone Propionate

Dosage form

Spray, Metered

Route

Nasal

Marketing category

ANDA · ANDA

Labeler

CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

3

Packages

3

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Fluticasone Propionate	50 ug/1	1797907	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Spray, Metered

Route of administration

Nasal

Presentations

6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Corticosteroid Hormone Receptor Agonists [MoA]	MoA	All 215 members
Corticosteroid [EPC]	EPC	All 215 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

207957

Application type

ANDA · Abbreviated New Drug Application

Approval date

May 26, 2016

Sponsor

HIKMA

Products on application

1

Submissions recorded

4

Products approved under application 207957.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
207957-001	FLUTICASONE PROPIONATE	SPRAY, METERED		FLUTICASONE PROPIONATE	Over-the-counter	—	RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

No

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 207957.
Type	No.	Action	Status	Date	Review
Supplement	4	Labeling	Approved	November 27, 2019	Standard
Supplement	2	Manufacturing (CMC)	Approved	December 29, 2016	Unknown
Supplement	1	Manufacturing (CMC)	Approved	August 2, 2016	Unknown
Original application	1		Approved	May 26, 2016	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260429). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260429

Indications and Usage

openFDA Drug Labeling

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • itchy nose • runny nose • itchy, watery eyes • sneezing

Purpose

openFDA Drug Labeling

Purpose Allergy symptom reliever

Dosage and Administration

openFDA Drug Labeling

Directions • read the Quick Start Guide for how to: • prime the bottle • use the spray • clean the spray nozzle • shake gently before each use • use this product only once a day • do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER • Week 1 – use 2 sprays in each nostril once daily • Week 2 through 6 months – use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms • After 6 months of daily use – ask your doctor if you can keep using CHILDREN 4 TO 11 YEARS OF AGE • the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. • an adult should supervise use • use 1 spray in each nostril once daily CHILDREN UNDER 4 YEARS OF AGE • do not use

Warnings

openFDA Drug Labeling

Warnings Only for use in the nose. Do not spray into your eyes or mouth. Do not use • in children under 4 years of age • to treat asthma • if you have an injury or surgery to your nose that is not fully healed • if you have ever had an allergic reaction to this product or any of the ingredients Ask a doctor before use if you have or had glaucoma or cataracts Ask a doctor or pharmacist before use if you are taking • medicine for HIV infection (such as ritonavir) • a steroid medicine for asthma, allergies or skin rash • ketoconazole pills (medicine for fungal infection) When using this product • the growth rate of some children may be slower • stinging or sneezing may occur for a few seconds right after use • do not share this bottle with anyone else as this may spread germs • remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if • you have, or come into contact with someone who has, chicken pox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection. • you get a constant whistling sound from your nose. This may be a sign of damage inside your nose. • you get an allergic reaction to this product. Seek medical help right away. • you get new changes to your vision that develop after starting this product • you have severe or frequent nosebleeds If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do Not Use

openFDA Drug Labeling

Do not use • in children under 4 years of age • to treat asthma • if you have an injury or surgery to your nose that is not fully healed • if you have ever had an allergic reaction to this product or any of the ingredients

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have or had glaucoma or cataracts

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if • you have, or come into contact with someone who has, chicken pox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection. • you get a constant whistling sound from your nose. This may be a sign of damage inside your nose. • you get an allergic reaction to this product. Seek medical help right away. • you get new changes to your vision that develop after starting this product • you have severe or frequent nosebleeds

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each spray) Fluticasone propionate (glucocorticoid)* 50 mcg * read the Question & Answer Leaflet

Adverse event reports

Source: openFDA FAERS

224,191

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: FLUTICASONE PROPIONATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
51316-818-08	51316-818	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	1 BOTTLE, SPRAY in 1 CARTON (51316-818-08) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY	April 13, 2026
21130-607-08	21130-607	Safeway	1 BOTTLE, SPRAY in 1 CARTON (21130-607-08) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY	March 24, 2025
0363-4023-08	0363-4023	Walgreen Company	1 BOTTLE, SPRAY in 1 CARTON (0363-4023-08) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY	July 10, 2024
51316-818	51316-818	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	—	April 13, 2026
21130-607	21130-607	Safeway	—	March 24, 2025
0363-4023	0363-4023	Walgreen Company	—	July 10, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.