FDA.reportPublic FDA data

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

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