FLONASE SENSIMIST

Product NDC
0135-0616
11-digit product format
001350616
Labeler code
0135
Product ID
0135-0616_6970c7c1-6d1e-42d1-a4e2-712b1bef7bc9
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
2017-07-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0616-012023-04-20C16284748780-1f386c64a-2c81-0266-e053-dadaa90a7c1aDrug Facts
0135-0616-032023-04-20C16284748780-1f386c64a-2c81-0266-e053-dadaa90a7c1aDrug Facts
0135-0616-012023-01-30C16284748780-1f386c64a-2c81-0266-e053-dadaa90a7c1aDrug Facts
0135-0616-032023-01-30C16284748780-1f386c64a-2c81-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0616-01FLONASE SENSIMISTALLERGY RELIEF60 in 1 BOTTLESPRAY, METERED607
0135-0616-01FLONASE SENSIMISTALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED17
0135-0616-03FLONASE SENSIMISTALLERGY RELIEF72 in 1 BOTTLESPRAY, METERED727
0135-0616-03FLONASE SENSIMISTALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0616-01ML - Milliliter0135-06161cfb8022-9daa-4a7e-87c6-6c630966476212017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0616FLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) SPRAY, METERED [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 4 package rows20240307_893234b5-be82-4425-b850-2b884637b18e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1869712FLONASE SENSIMIST 27.5 MCG/ACTUAT Metered Dose Nasal SprayPSN893234b5-be82-4425-b850-2b884637b18e7
1797890fluticasone furoate 27.5 MCG/ACTUAT Metered Dose Nasal SprayPSN893234b5-be82-4425-b850-2b884637b18e7
1869712fluticasone furoate 0.0275 MG/ACTUAT Metered Dose Nasal Spray [Flonase Sensimist]SBD893234b5-be82-4425-b850-2b884637b18e7
1797890fluticasone furoate 0.0275 MG/ACTUAT Metered Dose Nasal SpraySCD893234b5-be82-4425-b850-2b884637b18e7
1869712Flonase Sensimist 0.0275 MG/ACTUAT Metered Dose Nasal SpraySY893234b5-be82-4425-b850-2b884637b18e7
1869712Flonase Sensimist 27.5 MCG/ACTUAT Metered Dose Nasal SpraySY893234b5-be82-4425-b850-2b884637b18e7
1797890fluticasone furoate 27.5 MCG/ACTUAT Metered Dose Nasal SpraySY893234b5-be82-4425-b850-2b884637b18e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0616-01001350616011 BOTTLE in 1 PACKAGE (0135-0616-01) / 60 SPRAY, METERED in 1 BOTTLE1 bottle2017-07-010000-00-00NoNoCurrent
0135-0616-03001350616031 BOTTLE in 1 PACKAGE (0135-0616-03) / 72 SPRAY, METERED in 1 BOTTLE1 bottle2021-07-010000-00-00NoNoCurrent