FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
73581-530
Requested package NDC
73581-530-03
11-digit product format
735810530
Labeler code
73581
Product ID
73581-530_540f4233-f5e5-9b5b-e063-6394a90a9085
Type
HUMAN OTC DRUG
Nonproprietary name
fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
YYBA CORP
Application
ANDA218742
Marketing category
ANDA
Marketing start
2026-09-01
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A218742-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2026-03-16

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
2026-09-14 22:38:342026-08A218742-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2026-03-1684e616aacf4f…
2026-08-18 06:07:402026-07A218742-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2026-03-16caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218742-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2026-03-16a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Fluticasone Propionate
Brand name suffix
ALLERGY RELIEF
Listing expiration
2027-12-31

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
5348075c-63ca-20f7-e063-6394a90a3f5cAvailable on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Fluticasone Propionate ALLERGY RELIEFFLUTICASONE PROPIONATEGLENMARK THERAPEUTICS INC., USA9aaa30cf-1e3b-4382-91dc-568067a4b0ac2026-06-30WarningsExact identifier
application applno (ANDA): 218742
application number: ANDA218742
Fluticasone Propionate ALLERGY RELIEFFLUTICASONE PROPIONATEYYBA CORP5348075c-63ca-20f7-e063-6394a90a3f5c2026-06-12WarningsExact identifier
application applno (ANDA): 218742
application number: ANDA218742
ndc (package): 73581-530-03
ndc (product): 73581-530
ndc11 (package): 73581053003
Fluticasone Propionate ALLERGY RELIEFFLUTICASONE PROPIONATEGLENMARK THERAPEUTICS INC., USA5494106f-6792-409e-b63f-b63b981409592026-05-05WarningsExact identifier
application applno (ANDA): 218742
application number: ANDA218742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73581-530-03735810530033 BOTTLE in 1 CARTON (73581-530-03) / 144 SPRAY, METERED in 1 BOTTLE3 bottle2026-09-01NoNoCurrent