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Childrens Fluticasone Propionate

fluticasone propionate · Spray, Metered

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Childrens Fluticasone Propionate ALLERGY RELIEF
Generic name
fluticasone propionate
Dosage form
Spray, Metered
Route
Nasal
Marketing category
ANDA · ANDA
Labeler
GLENMARK THERAPEUTICS INC., USA
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
5
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
7

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@FDANDC Directory
Application number
218742
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 16, 2026
Sponsor
GLENMARK SPECLT
Products on application
1
Submissions recorded
1
Products approved under application 218742.
Product Trade name Form Strength Ingredient Status TE Flags
218742-001 FLUTICASONE PROPIONATE SPRAY, METERED FLUTICASONE PROPIONATE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 218742.
Type No. Action Status Date Review
Original application 1 Approved March 16, 2026 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260630). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260630 HUMAN OTC DRUG · 20251208

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 Allergy symptom reliever

Dosage and Administration

openFDA Drug Labeling

Directions • read the Quick Start Guide for how to: o prime the bottle o use the spray o 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 Only for use in the nose. Do not spray into your eyes or mouth.

FLUTICASONE PROPIONATE NASAL SPRAY, USP QUICK START GUIDE HOW TO START GETTING ALLERGY RELIEF RIGHT NOW USE THE RIGHT DOSE Fluticasone Propionate Nasal Spray, USP works best when you use it daily. Here’s how to get started. Children age 4 to 11 An adult should supervise use Use one spray in each nostril once daily. Don’t use more than one spray in each nostril per day. If you miss a dose , just use your regular dose the next day. Don’t add an extra dose. Check with a doctor if a child needs to use Fluticasone Propionate Nasal Spray, USP for longer than two months a year. Users age 12 or older In your first week Use two sprays in each nostril every day. Don’t use more than two sprays in each nostril per day. After your first week If your symptoms are under control, you may reduce to one spray in each nostril every day. If your symptoms get worse, go back to two sprays in each nostril. If you miss a dose, just use your regular dose the next day. Don’t add an extra dose. WARNING: Do not spray in your eyes. Only for use in your nose. KEEP IT CLEAN A clean spray nozzle helps ensure a full dose. Clean it weekly, or if it’s clogged. Don’t try to unblock nozzle with pin or sharp object – that can damage it. Remove spray nozzle by grasping at base and pulling up. Rinse under running tap, and dry at room temperature. Aim away from your face and gently replace spray nozzle until you hear a soft click. If spray nozzle is clogged, soak in warm water. Then repeat steps 2 and 3 . GET THE RELIEF YOU NEED Fluticasone Propionate Nasal Spray, USP can relieve your allergy symptoms. For best results, it’s important to get a full dose. Here’s how, in five easy steps. 1 Shake Gently shake spray bottle. Remove translucent cap. 2 Prime Do this when: • Starting new bottle • Haven’t used it in a week • Just cleaned nozzle Otherwise go to Step 3. Aim away from face. Grasp spray bottle as shown. Pump until fine mist appears. Pumped six times and still no mist? Spray nozzle may be clogged. See KEEP IT CLEAN. 3 Blow Blow nose gently to clear nostrils. 4 Aim Close one nostril and put tip of spray nozzle in other nostril. Put just the tip into your nose. Aim slightly away from center of nose. 5 Breathe and Spray While sniffing gently, press down on spray nozzle once or twice (according to dosing instructions). You’ll feel a light mist in your nose. Breathe out through your mouth. Repeat in other nostril. Wipe spray nozzle with clean tissue and replace cap. Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016 Revised: 12/2025 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 Figure 23

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

Ask a Doctor

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

WHAT TO EXPECT What it’s like to use Fluticasone Propionate Nasal Spray, USP. How soon will I get relief? You may start to feel relief the first day you use Fluticasone Propionate Nasal Spray, USP. Keep using it every day, though. It takes several days before Fluticasone Propionate Nasal Spray, USP builds up to full effectiveness. How long will the relief last? Fluticasone Propionate Nasal Spray, USP is meant to control your symptoms every day, all day and all night. To help you get this lasting relief, it’s important to use Fluticasone Propionate Nasal Spray, USP regularly, once a day. Does Fluticasone Propionate Nasal Spray, USP cause a "rebound" effect? No, Fluticasone Propionate Nasal Spray, USP does not cause a rebound effect. Some nasal decongestant sprays may cause your nasal passages to swell up even more when you use them too often or for longer than their label says you should (three days). This is sometimes called a “rebound effect.” Fluticasone Propionate Nasal Spray, USP is a different kind of medicine and does not cause any rebound effect. You can use Fluticasone Propionate Nasal Spray, USP for up to six months if you are age 12 or older or up to two months a year if you are age 4 to 11 before checking with a doctor. Will Fluticasone Propionate Nasal Spray, USP make me drowsy? No, Fluticasone Propionate Nasal Spray, USP does not cause drowsiness. Some allergy medications can cause drowsiness, but Fluticasone Propionate Nasal Spray, USP does not. Why does Fluticasone Propionate Nasal Spray, USP have a smell? The light floral scent you may notice comes from one of the important ingredients in the Fluticasone Propionate Nasal Spray, USP formula. No fragrance is added to Fluticasone Propionate Nasal Spray, USP. What if little or nothing is spraying out? Try priming the spray bottle. It may take a few pumps to get the dispenser spraying again. If that doesn’t work, the spray nozzle may be clogged. You can clean it following the directions in the Quick Start Guide on the other side. What if I feel stinging in my nose, or I sneeze? Some people may feel a slight stinging, or may sneeze, after spraying Fluticasone Propionate Nasal Spray, USP in their nostrils. This feeling should go away in a few seconds. What if I feel or taste the medicine in my throat? Generally, you can avoid this by taking a shallower breath next time you spray Fluticasone Propionate Nasal Spray, USP into your nostrils. For example, take the kind of breath you would use to smell a flower. What if I have chicken pox, measles or tuberculosis or come into contact with someone who does? Stop using Fluticasone Propionate Nasal Spray, USP and ask your doctor. What if I’m having severe sinus pain? If you feel severe pain in your face, have thick nasal discharge, or think you may have a sinus infection, stop using Fluticasone Propionate Nasal Spray, USP and see your doctor. Your doctor may want to consider if other medicines are needed. What if my symptoms aren’t better after one week? If you have used Fluticasone Propionate Nasal Spray, USP for a week and your allergy symptoms are not getting better, stop use and ask your doctor. You may have an infection. Does Fluticasone Propionate Nasal Spray, USP have side effects? Serious side effects are rare with Fluticasone Propionate Nasal Spray, USP because Fluticasone Propionate Nasal Spray, USP works in your nose, and barely any of it travels through your body. However, like all medicines, Fluticasone Propionate Nasal Spray, USP can cause side effects in some people. Here are some side effects that have been reported when using Fluticasone Propionate Nasal Spray, USP. If you have any concerns about side effects, talk with your doctor. Side effect What could happen What to do Allergic reaction to the product • Sudden swelling of face or tongue • A rash • Wheezing or feeling faint If you feel any of these symptoms, stop using Fluticasone Propionate Nasal Spray, USP and see a doctor right away. Nose injury • Severe …

Active Ingredient

openFDA Drug Labeling

Drug Facts Active ingredient (in each spray) Fluticasone propionate USP (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
58602-018-04 58602-018 Aurohealth LLC 3 BOTTLE in 1 CARTON (58602-018-04) / 72 SPRAY, METERED in 1 BOTTLE December 16, 2025
58602-018-42 58602-018 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-018-42) / 60 SPRAY, METERED in 1 BOTTLE May 10, 2024
58602-018-45 58602-018 Aurohealth LLC 2 BOTTLE in 1 CARTON (58602-018-45) / 72 SPRAY, METERED in 1 BOTTLE December 16, 2025
58602-018-51 58602-018 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-018-51) / 72 SPRAY, METERED in 1 BOTTLE December 16, 2025
72657-166-72 72657-166 GLENMARK THERAPEUTICS INC., USA 1 BOTTLE in 1 CARTON (72657-166-72) / 72 SPRAY, METERED in 1 BOTTLE June 30, 2026
58602-018 58602-018 Aurohealth LLC — May 10, 2024
72657-166 72657-166 GLENMARK THERAPEUTICS INC., USA — June 30, 2026

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 · 10 sections on this page.