FDA.reportPublic FDA data

CHILDRENS FLUTICASONE PROPIONATE

Product NDC
58602-018
11-digit product format
586020018
Labeler code
58602
Product ID
58602-018_0bdbc9dc-56d3-478b-97bc-7e8a43d200b0
Type
HUMAN OTC DRUG
Nonproprietary name
fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Aurohealth LLC
Application
ANDA217088
Marketing category
ANDA
Marketing start
2024-05-10
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A217088-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-101e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217088-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2024-05-10a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
CHILDRENS FLUTICASONE PROPIONATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O2GMZ0LF5WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1797907Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
180ef101-dca6-496f-8376-63449d82d083Available on FDA.report

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
58602-018-04CHILDRENS FLUTICASONE PROPIONATE3 in 1 CARTONSPRAY, METERED33
58602-018-04CHILDRENS FLUTICASONE PROPIONATE72 in 1 BOTTLESPRAY, METERED723
58602-018-42CHILDRENS FLUTICASONE PROPIONATE60 in 1 BOTTLESPRAY, METERED603
58602-018-42CHILDRENS FLUTICASONE PROPIONATE1 in 1 CARTONSPRAY, METERED13
58602-018-45CHILDRENS FLUTICASONE PROPIONATE2 in 1 CARTONSPRAY, METERED23
58602-018-45CHILDRENS FLUTICASONE PROPIONATE72 in 1 BOTTLESPRAY, METERED723
58602-018-51CHILDRENS FLUTICASONE PROPIONATE1 in 1 CARTONSPRAY, METERED13
58602-018-51CHILDRENS FLUTICASONE PROPIONATE72 in 1 BOTTLESPRAY, METERED723

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-018CHILDRENS FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) SPRAY, METERED [AUROHEALTH LLC]2Current NDC, 8 package rows20250528_180ef101-dca6-496f-8376-63449d82d083.zip

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEFamily Dollar Stores, LLC4dd65267-9905-4f45-e063-6294a90a25162026-06-17WarningsExact identifier
application applno (ANDA): 217088
application number: ANDA217088
Mucinex Nasal Congestion and Allergy ReliefFLUTICASONE PROPIONATEReckitt Benckiser LLC47d8bb65-0bff-f24d-e063-6394a90affaf2026-05-20WarningsExact identifier
application applno (ANDA): 217088
application number: ANDA217088
365 WHOLE FOODS MARKET FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEWhole Foods Market, Inc.313517bd-cb08-49a5-8ef1-e5522cc21c802026-01-22WarningsExact identifier
application applno (ANDA): 217088
application number: ANDA217088
CHILDRENS FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEAurohealth LLC180ef101-dca6-496f-8376-63449d82d0832025-12-08WarningsExact identifier
application applno (ANDA): 217088
application number: ANDA217088
ndc (product): 58602-018
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEAurohealth LLC044a06a1-74fc-43ff-b136-37ad412209412025-12-08WarningsExact identifier
application applno (ANDA): 217088
application number: ANDA217088
FLUTICAREFLUTICASONE PROPIONATEINNOVUS PHARMACEUTICALS, INC.fed545ab-6a85-4ce3-8651-370e279db49e2025-07-16WarningsExact identifier
application applno (ANDA): 217088
application number: ANDA217088

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN180ef101-dca6-496f-8376-63449d82d0833
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD180ef101-dca6-496f-8376-63449d82d0833
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY180ef101-dca6-496f-8376-63449d82d0833

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-018-04586020018043 BOTTLE in 1 CARTON (58602-018-04) / 72 SPRAY, METERED in 1 BOTTLE3 bottle2025-12-16NoNoCurrent
58602-018-42586020018421 BOTTLE in 1 CARTON (58602-018-42) / 60 SPRAY, METERED in 1 BOTTLE1 bottle2024-05-10NoNoCurrent
58602-018-45586020018452 BOTTLE in 1 CARTON (58602-018-45) / 72 SPRAY, METERED in 1 BOTTLE2 bottle2025-12-16NoNoCurrent
58602-018-51586020018511 BOTTLE in 1 CARTON (58602-018-51) / 72 SPRAY, METERED in 1 BOTTLE1 bottle2025-12-16NoNoCurrent