FDA.reportPublic FDA data

CHILDRENS FLONASE

Product NDC
0135-0582
11-digit product format
001350582
Labeler code
0135
Product ID
0135-0582_19c67359-3ee5-440b-82c3-efa11b775cdb
Type
HUMAN OTC DRUG
Nonproprietary name
fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Haleon US Holdings LLC
Application
NDA205434
Marketing category
NDA
Marketing start
2016-02-29
Substance
FLUTICASONE PROPIONATE
Active strength
50 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
CHILDRENS FLONASE
Brand name suffix
ALLERGY RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui1797907, 1797933

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0582-012020-12-02C16284748780-19d75b9d0-1ecd-f424-e053-dadaa90a57ceDrug Facts
0135-0582-022020-12-02C16284748780-19d75b9d0-1ecd-f424-e053-dadaa90a57ceDrug Facts
0135-0582-032020-12-02C16284748780-19d75b9d0-1ecd-f424-e053-dadaa90a57ceDrug Facts
0135-0582-012020-01-31C16284748780-19d75b9d0-1ecd-f424-e053-dadaa90a57ceDrug Facts
0135-0582-022020-01-31C16284748780-19d75b9d0-1ecd-f424-e053-dadaa90a57ceDrug Facts
0135-0582-032020-01-31C16284748780-19d75b9d0-1ecd-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0582-01CHILDRENS FLONASEALLERGY RELIEF60 in 1 BOTTLESPRAY, METERED609
0135-0582-01CHILDRENS FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED19
0135-0582-02CHILDRENS FLONASEALLERGY RELIEF60 in 1 BOTTLESPRAY, METERED609
0135-0582-02CHILDRENS FLONASEALLERGY RELIEF2 in 1 PACKAGESPRAY, METERED29
0135-0582-03CHILDRENS FLONASEALLERGY RELIEF30 in 1 BOTTLESPRAY, METERED309
0135-0582-03CHILDRENS FLONASEALLERGY RELIEF1 in 1 CARTONSPRAY, METERED19
0135-0582-05CHILDRENS FLONASEALLERGY RELIEF90 in 1 BOTTLESPRAY, METERED909
0135-0582-05CHILDRENS FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED19
0135-0582-04CHILDRENS FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED15
0135-0582-04CHILDRENS FLONASEALLERGY RELIEF72 in 1 BOTTLESPRAY, METERED725

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0582-01ML - Milliliter0135-0582470ae558-b239-4ade-9c47-67e894c77f7e12016-03-04
0135-0582-02ML - Milliliter0135-058237d09e02-34fc-43d1-ab8f-004cb4618ffe12016-05-16
0135-0582-04ML - Milliliter0135-058295e0d1d6-10b3-4efd-9bd6-9fa08d72955812021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0582CHILDRENS FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [HALEON US HOLDINGS LLC]9Current NDC, Legacy NDC, 8 package rows20240209_3adff80f-fca7-4cc5-b106-0f68f71c85b0.zip
0135-0582CHILDRENS FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 2 package rows20240307_fab7a1f4-75e0-416f-9644-07aff08e6ab0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797933FLONASE 50 MCG/ACTUAT Metered Dose Nasal SprayPSN3adff80f-fca7-4cc5-b106-0f68f71c85b09
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN3adff80f-fca7-4cc5-b106-0f68f71c85b09
1797933fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Flonase]SBD3adff80f-fca7-4cc5-b106-0f68f71c85b09
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD3adff80f-fca7-4cc5-b106-0f68f71c85b09
1797933Flonase 0.05 MG/ACTUAT Metered Dose Nasal SpraySY3adff80f-fca7-4cc5-b106-0f68f71c85b09
1797933Flonase 50 MCG/ACTUAT Metered Dose Nasal SpraySY3adff80f-fca7-4cc5-b106-0f68f71c85b09
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY3adff80f-fca7-4cc5-b106-0f68f71c85b09
1797933FLONASE 50 MCG/ACTUAT Metered Dose Nasal SprayPSNfab7a1f4-75e0-416f-9644-07aff08e6ab05
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNfab7a1f4-75e0-416f-9644-07aff08e6ab05
1797933fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Flonase]SBDfab7a1f4-75e0-416f-9644-07aff08e6ab05
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDfab7a1f4-75e0-416f-9644-07aff08e6ab05
1797933Flonase 0.05 MG/ACTUAT Metered Dose Nasal SpraySYfab7a1f4-75e0-416f-9644-07aff08e6ab05
1797933Flonase 50 MCG/ACTUAT Metered Dose Nasal SpraySYfab7a1f4-75e0-416f-9644-07aff08e6ab05
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYfab7a1f4-75e0-416f-9644-07aff08e6ab05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0582-01001350582011 BOTTLE in 1 PACKAGE (0135-0582-01) / 60 SPRAY, METERED in 1 BOTTLE1 bottle2016-02-290000-00-00NoNoCurrent
0135-0582-02001350582022 BOTTLE in 1 PACKAGE (0135-0582-02) / 60 SPRAY, METERED in 1 BOTTLE2 bottle2016-02-290000-00-00NoNoCurrent
0135-0582-03001350582031 BOTTLE in 1 CARTON (0135-0582-03) / 30 SPRAY, METERED in 1 BOTTLE1 bottle2016-06-300000-00-00NoNoCurrent
0135-0582-04001350582041 BOTTLE in 1 PACKAGE (0135-0582-04) / 72 SPRAY, METERED in 1 BOTTLE1 bottle2016-02-290000-00-00NoNoCurrent
0135-0582-05001350582051 BOTTLE in 1 PACKAGE (0135-0582-05) / 90 SPRAY, METERED in 1 BOTTLE1 bottle2021-07-010000-00-00NoNoCurrent