FLONASE SENSIMIST

Product NDC
0135-0615
11-digit product format
001350615
Labeler code
0135
Product ID
0135-0615_85fd731d-433f-4eba-aad8-6eda4550138e
Type
HUMAN OTC DRUG
Nonproprietary name
fluticasone furoate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Haleon US Holdings LLC
Application
NDA022051
Marketing category
NDA
Marketing start
2017-02-01
Substance
FLUTICASONE FUROATE
Active strength
27.5 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022051-002FLONASE SENSIMIST ALLERGY RELIEFFLUTICASONE FUROATE0.0275MG/SPRAYSPRAY, METERED / NASALRLD, RS2016-08-02

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022051-00280622642026-04-05Drug product2016-08-31
N022051-00283478792028-07-15Drug product2016-08-31
N022051-00281474612028-10-15Drug product2016-08-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLONASE SENSIMIST ALLERGY RELIEFFLUTICASONE FUROATEHaleon US Holdings LLC107100af-7ca2-44e8-b067-c0ab0a19a6dc2024-12-19WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Only for use in the nose. Do not spray into your eyes or mouth. Do not use • in children under 2 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.

Additional Listing Data#

Finished product
Yes
Brand name base
FLONASE SENSIMIST
Brand name suffix
ALLERGY RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE FUROATE27.5 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJS86977WNV
Rxcui1797890, 1869712

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
0135-0615-01FLONASE SENSIMISTALLERGY RELIEF30 in 1 BOTTLESPRAY, METERED3011
0135-0615-01FLONASE SENSIMISTALLERGY RELIEF1 in 1 CARTONSPRAY, METERED111
0135-0615-02FLONASE SENSIMISTALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED111
0135-0615-02FLONASE SENSIMISTALLERGY RELIEF60 in 1 BOTTLESPRAY, METERED6011
0135-0615-03FLONASE SENSIMISTALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED12011
0135-0615-03FLONASE SENSIMISTALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED111
0135-0615-04FLONASE SENSIMISTALLERGY RELIEF3 in 1 PACKAGESPRAY, METERED311
0135-0615-04FLONASE SENSIMISTALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED12011
0135-0615-05FLONASE SENSIMISTALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED12011
0135-0615-05FLONASE SENSIMISTALLERGY RELIEF2 in 1 PACKAGESPRAY, METERED211
0135-0615-06FLONASE SENSIMISTALLERGY RELIEF72 in 1 BOTTLESPRAY, METERED7211
0135-0615-06FLONASE SENSIMISTALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0615-02ML - Milliliter0135-06152920fd47-0bde-486a-a669-ec6d75386b1712017-03-06
0135-0615-03ML - Milliliter0135-0615e1d1dcab-8308-414e-8169-9e3bdc51e4cc12017-03-06
0135-0615-04ML - Milliliter0135-061569ff5e4b-afdb-4e64-82f3-a086fe1851b412017-03-06
0135-0615-05ML - Milliliter0135-0615bfcb9519-ab43-4b25-99d7-a9168861133012017-07-07
0135-0615-06ML - Milliliter0135-06158e22a1ec-1bf4-436e-8e3b-dc0b647685ea12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0615FLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) SPRAY, METERED [HALEON US HOLDINGS LLC]11Current NDC, Legacy NDC, 12 package rows20241222_107100af-7ca2-44e8-b067-c0ab0a19a6dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1869712FLONASE SENSIMIST 27.5 MCG/ACTUAT Metered Dose Nasal SprayPSN107100af-7ca2-44e8-b067-c0ab0a19a6dc11
1797890fluticasone furoate 27.5 MCG/ACTUAT Metered Dose Nasal SprayPSN107100af-7ca2-44e8-b067-c0ab0a19a6dc11
1869712fluticasone furoate 0.0275 MG/ACTUAT Metered Dose Nasal Spray [Flonase Sensimist]SBD107100af-7ca2-44e8-b067-c0ab0a19a6dc11
1797890fluticasone furoate 0.0275 MG/ACTUAT Metered Dose Nasal SpraySCD107100af-7ca2-44e8-b067-c0ab0a19a6dc11
1869712Flonase Sensimist 0.0275 MG/ACTUAT Metered Dose Nasal SpraySY107100af-7ca2-44e8-b067-c0ab0a19a6dc11
1869712Flonase Sensimist 27.5 MCG/ACTUAT Metered Dose Nasal SpraySY107100af-7ca2-44e8-b067-c0ab0a19a6dc11
1797890fluticasone furoate 27.5 MCG/ACTUAT Metered Dose Nasal SpraySY107100af-7ca2-44e8-b067-c0ab0a19a6dc11
1869712FLONASE SENSIMIST 27.5 MCG/ACTUAT Metered Dose Nasal SprayPSN51fe1787-6425-4df0-9890-e7f34651be355
1797890fluticasone furoate 27.5 MCG/ACTUAT Metered Dose Nasal SprayPSN51fe1787-6425-4df0-9890-e7f34651be355
1869712fluticasone furoate 0.0275 MG/ACTUAT Metered Dose Nasal Spray [Flonase Sensimist]SBD51fe1787-6425-4df0-9890-e7f34651be355
1797890fluticasone furoate 0.0275 MG/ACTUAT Metered Dose Nasal SpraySCD51fe1787-6425-4df0-9890-e7f34651be355
1869712Flonase Sensimist 0.0275 MG/ACTUAT Metered Dose Nasal SpraySY51fe1787-6425-4df0-9890-e7f34651be355
1869712Flonase Sensimist 27.5 MCG/ACTUAT Metered Dose Nasal SpraySY51fe1787-6425-4df0-9890-e7f34651be355
1797890fluticasone furoate 27.5 MCG/ACTUAT Metered Dose Nasal SpraySY51fe1787-6425-4df0-9890-e7f34651be355
1869712FLONASE SENSIMIST 27.5 MCG/ACTUAT Metered Dose Nasal SprayPSNa008dc12-c21b-456e-9824-fcc5ce64d4ba3
1797890fluticasone furoate 27.5 MCG/ACTUAT Metered Dose Nasal SprayPSNa008dc12-c21b-456e-9824-fcc5ce64d4ba3
1869712fluticasone furoate 0.0275 MG/ACTUAT Metered Dose Nasal Spray [Flonase Sensimist]SBDa008dc12-c21b-456e-9824-fcc5ce64d4ba3
1797890fluticasone furoate 0.0275 MG/ACTUAT Metered Dose Nasal SpraySCDa008dc12-c21b-456e-9824-fcc5ce64d4ba3
1869712Flonase Sensimist 0.0275 MG/ACTUAT Metered Dose Nasal SpraySYa008dc12-c21b-456e-9824-fcc5ce64d4ba3
1869712Flonase Sensimist 27.5 MCG/ACTUAT Metered Dose Nasal SpraySYa008dc12-c21b-456e-9824-fcc5ce64d4ba3
1797890fluticasone furoate 27.5 MCG/ACTUAT Metered Dose Nasal SpraySYa008dc12-c21b-456e-9824-fcc5ce64d4ba3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0615-01001350615011 BOTTLE in 1 CARTON (0135-0615-01) / 30 SPRAY, METERED in 1 BOTTLE1 bottle2017-02-010000-00-00NoNoCurrent
0135-0615-02001350615021 BOTTLE in 1 PACKAGE (0135-0615-02) / 60 SPRAY, METERED in 1 BOTTLE1 bottle2017-02-010000-00-00NoNoCurrent
0135-0615-03001350615031 BOTTLE in 1 PACKAGE (0135-0615-03) / 120 SPRAY, METERED in 1 BOTTLE1 bottle2017-02-010000-00-00NoNoCurrent
0135-0615-04001350615043 BOTTLE in 1 PACKAGE (0135-0615-04) / 120 SPRAY, METERED in 1 BOTTLE3 bottle2017-02-010000-00-00NoNoCurrent
0135-0615-05001350615052 BOTTLE in 1 PACKAGE (0135-0615-05) / 120 SPRAY, METERED in 1 BOTTLE2 bottle2017-07-010000-00-00NoNoCurrent
0135-0615-06001350615061 BOTTLE in 1 PACKAGE (0135-0615-06) / 72 SPRAY, METERED in 1 BOTTLE1 bottle2019-01-220000-00-00NoNoCurrent