FLONASE

Manufacturer
Haleon US Holdings LLC
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
21
Source
full-release
Hydrated at
2026-06-01 00:47:48

Label at a glance#

ProductFLONASE ALLERGY RELIEF
Active ingredientFLUTICASONE PROPIONATE
Label structure10 sections

Indications and uses

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

Dosage and administration

• 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...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Fluticasone propionate (glucocorticoid)* 50 mcg
*read the Question & Answer Leaflet

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

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 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

STORAGE AND HANDLING 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° and 30°C (39° and 86°F)
  • keep this label and enclosed materials. They contain important additional information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethylalcohol, polysorbate 80, purified water, sodium carboxymethylcellulose

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-844-FLONASE (1-844-356-6273)

Generic Section

SPL UNCLASSIFIED SECTION

What problems can FLONASE Allergy Relief help with?

FLONASE Allergy Relief helps relieve a broad range of uncomfortable symptoms like congestion and itchy eyes.

Nasal symptoms

Eye symptoms

These symptoms can be triggered by allergens like pollen, mold, dust or pet dander.

Outdoor allergens

Animal allergens

Indoor allergens

IMPORTANT – Peel here for complete Drug Facts label. Children 4-11: do not use for more than 2 months a year.

Be sure to read the Quick Start Guide and Question & Answer Leaflet inside package

TAMPER-EVIDENTfeatures for your protection. The product is packaged in a sealed container. Under the cap and nozzle, each bottle has an aluminum seal around bottle neck. Do not use if any of these features are torn or damaged.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FLONASE

ALLERGY RELIEF

Fluticasone Propionate Nasal Spray 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

24 HOUR RELIEF

0.62 fl oz (18.2 mL)

144 METERED SPRAYS

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

Flonase Allergy 144 sprays
Flonase Allergy 144 sprays

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1797933FLONASE 50 MCG/ACTUAT Metered Dose Nasal SprayPSN21
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN21
1797933fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Flonase]SBD21
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD21
1797933Flonase 0.05 MG/ACTUAT Metered Dose Nasal SpraySY21
1797933Flonase 50 MCG/ACTUAT Metered Dose Nasal SpraySY21
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY21

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FLUTICASONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2Product name120140508
667f427a-8698-a508-767a-53ed61b4c2e9Product name120140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9Product name120140508
6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
90fec588-984c-4375-cfd4-7e40114bdf80Product name120140508
9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0576-01FLONASEALLERGY RELIEF1 in 1 CARTONSPRAY, METERED121
0135-0576-01FLONASEALLERGY RELIEF30 in 1 BOTTLESPRAY, METERED3021
0135-0576-02FLONASEALLERGY RELIEF60 in 1 BOTTLESPRAY, METERED6021
0135-0576-02FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED121
0135-0576-03FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED121
0135-0576-03FLONASEALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED12021
0135-0576-04FLONASEALLERGY RELIEF3 in 1 PACKAGESPRAY, METERED321
0135-0576-04FLONASEALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED12021
0135-0576-12FLONASEALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED12021
0135-0576-12FLONASEALLERGY RELIEF2 in 1 PACKAGESPRAY, METERED221
0135-0576-14FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED121
0135-0576-14FLONASEALLERGY RELIEF144 in 1 BOTTLESPRAY, METERED14421
0135-0576-15FLONASEALLERGY RELIEF2 in 1 PACKAGESPRAY, METERED221
0135-0576-15FLONASEALLERGY RELIEF144 in 1 BOTTLESPRAY, METERED14421
0135-0576-16FLONASEALLERGY RELIEF144 in 1 BOTTLESPRAY, METERED14421
0135-0576-16FLONASEALLERGY RELIEF3 in 1 PACKAGESPRAY, METERED321
0135-0576-17FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED121
0135-0576-17FLONASEALLERGY RELIEF72 in 1 BOTTLESPRAY, METERED7221
0135-0576-18FLONASEALLERGY RELIEF90 in 1 BOTTLESPRAY, METERED9021
0135-0576-18FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0576FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [HALEON US HOLDINGS LLC]21Current NDC, Legacy NDC, 20 package rows20241222_b6134ba0-b70a-4eac-9a82-cef64b242c1d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0576-02ML - Milliliter0135-0576530d5343-ecd6-4d4c-8c91-009427e86b7d12015-02-02
0135-0576-03ML - Milliliter0135-0576865c93a8-8bed-4d15-9ec7-6d112b4d31e712015-02-02
0135-0576-04ML - Milliliter0135-0576d0a68cc5-b3ef-40cb-98e4-287b6f5a3b0f12015-02-02
0135-0576-14ML - Milliliter0135-0576dd0b22db-120a-4750-9412-a0b7f66f9ffb12018-08-13
0135-0576-15ML - Milliliter0135-05765048df9c-fbbf-4899-880b-a2954d70f8bf12018-03-08
0135-0576-16ML - Milliliter0135-0576f5dd4265-38d2-4dc4-9d1c-e8e9a95a69df12018-03-08
0135-0576-17ML - Milliliter0135-0576cc1b971f-e7c4-4473-adcd-85d87f59cef712020-04-20
0135-0576-18ML - Milliliter0135-05762b27c673-6c75-4a9c-babe-637772aafa2012025-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5W6
FLUTICASONEACTIVE MOIETYCUT2W21N7U6
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W76
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3116
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U6
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W26
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA74686
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H6
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

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

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 14 · 836 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii candidate
308 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SUSPENSION / ORAL560 mgExact identifier — unii candidate
484 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
308 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
308 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY, METERED / NASAL1 mgExact identifier — unii+route+dosage form
11 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, EXTENDED RELEASE / ORAL1246 mgExact identifier — unii candidate
308 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
308 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, DELAYED RELEASE / ORAL789.6 mgExact identifier — unii candidate
308 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
308 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1576 mgExact identifier — unii candidate
308 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / ORAL280 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRAMUSCULAR30 mgExact identifier — unii candidate
484 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SPRAY, METERED / NASAL50 mgExact identifier — unii+route+dosage form
11 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SOLUTION / ORAL161 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CREAM / VAGINAL0.75 %w/wExact identifier — unii candidate
484 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
308 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, FILM COATED, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
484 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
308 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii candidate
308 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAVITREAL0.5 %w/vExact identifier — unii candidate
484 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
308 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAMUSCULAR30 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GRANULE, FOR SUSPENSION / ORAL15.63 mg/5mlExact identifier — unii candidate
484 equally ranked IID candidates
PHENYLETHYL ALCOHOLPHENYLETHYL ALCOHOLML9LGA7468SPRAY, METERED / NASAL2 mgExact identifier — unii+route+dosage form
11 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAVITREAL0.5 %w/vExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAMUSCULAR30 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, DELAYED RELEASE / ORAL280 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRAMUSCULAR30 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311POWDER, FOR SOLUTION / ORAL161 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION/ DROPS / ORAL12.85 mg/2.5mlExact identifier — unii candidate
484 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
308 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, EXTENDED RELEASE / ORAL933 mgExact identifier — unii candidate
484 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii candidate
308 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SPRAY, METERED / NASAL50 mgExact identifier — unii+route+dosage form
11 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii candidate
308 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION/ DROPS / ORAL12.85 mg/2.5mlExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAVITREAL0.5 %w/vExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYRUP / ORAL26.5 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, FILM COATED / ORAL50 mgExact identifier — unii candidate
484 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii candidate
308 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii+route+dosage form
11 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii candidate
308 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
308 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, EXTENDED RELEASE / ORAL1246 mgExact identifier — unii candidate
308 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / OPHTHALMIC1 mgExact identifier — unii candidate
484 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, EXTENDED RELEASE / ORAL1246 mgExact identifier — unii candidate
308 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION / INTRA-ARTICULAR25 mgExact identifier — unii candidate
484 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, COATED PELLETS / ORAL456 mgExact identifier — unii candidate
308 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii+route+dosage form
11 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311AEROSOL, FOAM / VAGINAL0.2 %w/wExact identifier — unii candidate
484 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, DELAYED RELEASE / ORAL789.6 mgExact identifier — unii candidate
308 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / ORAL3480 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / ORAL3480 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311GEL / DENTAL0.4 %w/wExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311PASTE / DENTAL249 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, CHEWABLE / ORAL24.75 mgExact identifier — unii candidate
484 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311AEROSOL, FOAM / VAGINAL0.2 %w/wExact identifier — unii candidate
484 equally ranked IID candidates

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
N205434-001FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23

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 22:38:342026-08N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-2384e616aacf4f…
2026-08-18 06:07:402026-07N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-233f01610625f2…
2019-09-15 20:21 UTC2019-09N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-233f0d92c62455…
2023-05-13 08:27 UTC2023-05N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23053a50430f4f…
2023-01-26 05:58 UTC2023-01N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23f41ea6bd6efb…

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
FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATEHaleon US Holdings LLCb6134ba0-b70a-4eac-9a82-cef64b242c1d2024-12-19WarningsExact identifier
ndc (package): 0135-0576-01
ndc (package): 0135-0576-04
ndc (package): 0135-0576-02
ndc (package): 0135-0576-17
ndc (package): 0135-0576-18
ndc (package): 0135-0576-14
ndc (package): 0135-0576-16
ndc (package): 0135-0576-15
ndc (package): 0135-0576-12
ndc (package): 0135-0576-03
ndc (product): 0135-0576
ndc11 (package): 00135057603
ndc11 (package): 00135057601
ndc11 (package): 00135057616
ndc11 (package): 00135057618
ndc11 (package): 00135057604
ndc11 (package): 00135057615
ndc11 (package): 00135057617
ndc11 (package): 00135057612
ndc11 (package): 00135057614
ndc11 (package): 00135057602
spl id: fe356980-6a1c-4830-b69c-7adb271b2e20
spl set id: b6134ba0-b70a-4eac-9a82-cef64b242c1d

Reported adverse events (FAERS/openFDA)#

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