Drug Facts

Manufacturer
P & L Development, LLC
Effective date
2026-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-18 02:02:49

Label at a glance#

ProductFluticasone Propionate
Active ingredientFLUTICASONE PROPIONATE
Label structure10 sections

Indications and uses

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

Dosage and administration

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 - a...

Label contents#

Full prescribing information#

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Fluticasone propionate (glucocorticoid) 50 mcg.

Purpose

OTC - PURPOSE SECTION

Allergy symptom reliever

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • nasal congestion 
  • runny nose
  • sneezing 
  • itchy nose
  • itchy, watery eyes

Warnings

WARNINGS SECTION

Only for use in the nose. Do not spray into your eyes or mouth.

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

have or had glaucoma or cataracts

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

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

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

SPL UNCLASSIFIED SECTION

  • you may start to feel relief the first day and full effect after several days of regular, once-a-day use
  •  store between 4°C to 30°C (39° and 86°F)
  • keep this label and enclosed materials. They contain important additional information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Flonase® Allergy Relief††

24 HOUR RELIEF

Allergy

Nasal Spray

Fluticasone Propionate

50 mcg per spray

allergy symptom reliever

(Glucocorticoid)**

Non-Drowsy Relief of 

  • Nasal congestion
  • Itchy, watery eyes
  • itchy nose
  • Runny nose
  • Sneezing

Full Prescription Strength 

Metered Sprays

*Fluticasone propionate is a steroid medicine know as a glucocorticoid.

††This product is not manufactured or distributed by Haleon US Holdings LLC, Distributor of Flonase® Allergy Relief.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED, TORN OR BROKEN OR IF THE SEAL AROUND THE PRODUCT LABELED "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING

DISTRIBUTED BY:

Package label (72 ms)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WELLNESS BASICS Allergy Relief Nasal Spray
WELLNESS BASICS Allergy Relief Nasal Spray

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130000000000000GTIN-13: 0000000000000
EAN-13: 0000000000000
GTIN-12: 000000000000
UPC-A: 000000000000
GTIN storage (14 digits): 00000000000000
fluticasone-propionate-allergy-relief-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59726-35059726-350-54, 59726-350-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208150-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-2984e616aacf4f…
2026-08-18 06:07:402026-07A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-293f01610625f2…
2019-09-15 20:21 UTC2019-09A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29f41ea6bd6efb…

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
Fluticasone PropionateFLUTICASONE PROPIONATEP & L Development, LLCe3347976-facd-49b6-9ae1-7ed3cd02ba962026-07-02WarningsExact identifier
ndc (package): 59726-350-38
ndc (package): 59726-350-54
ndc (product): 59726-350
ndc11 (package): 59726035054
ndc11 (package): 59726035038
spl id: 643792c9-892a-4e0c-91a5-8186c78ed5ac
spl set id: e3347976-facd-49b6-9ae1-7ed3cd02ba96

Reported adverse events (FAERS/openFDA)#

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