FDA.reportPublic FDA data

Fluticasone Propionate

Product NDC
72657-159
Requested package NDC
72657-159-36
11-digit product format
726570159
Labeler code
72657
Product ID
72657-159_282e11b5-3962-4e31-87c0-18163fa04f92
Type
HUMAN OTC DRUG
Nonproprietary name
fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
GLENMARK THERAPEUTICS INC., USA
Application
ANDA218742
Marketing category
ANDA
Marketing start
2026-03-16
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
5494106f-6792-409e-b63f-b63b98140959Available 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
72657-159-12Fluticasone PropionateALLERGY RELIEF1 in 1 CARTONSPRAY, METERED12
72657-159-12Fluticasone PropionateALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED1202
72657-159-14Fluticasone PropionateALLERGY RELIEF1 in 1 CARTONSPRAY, METERED12
72657-159-14Fluticasone PropionateALLERGY RELIEF144 in 1 BOTTLESPRAY, METERED1442
72657-159-24Fluticasone PropionateALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED1202
72657-159-24Fluticasone PropionateALLERGY RELIEF2 in 1 CARTONSPRAY, METERED22
72657-159-28Fluticasone PropionateALLERGY RELIEF2 in 1 CARTONSPRAY, METERED22
72657-159-28Fluticasone PropionateALLERGY RELIEF144 in 1 BOTTLESPRAY, METERED1442
72657-159-36Fluticasone PropionateALLERGY RELIEF3 in 1 CARTONSPRAY, METERED32
72657-159-36Fluticasone PropionateALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED1202
72657-159-42Fluticasone PropionateALLERGY RELIEF144 in 1 BOTTLESPRAY, METERED1442
72657-159-42Fluticasone PropionateALLERGY RELIEF3 in 1 CARTONSPRAY, METERED32
72657-159-48Fluticasone PropionateALLERGY RELIEF4 in 1 CARTONSPRAY, METERED42
72657-159-48Fluticasone PropionateALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED1202
72657-159-60Fluticasone PropionateALLERGY RELIEF60 in 1 BOTTLESPRAY, METERED602
72657-159-60Fluticasone PropionateALLERGY RELIEF1 in 1 CARTONSPRAY, METERED12
72657-159-72Fluticasone PropionateALLERGY RELIEF72 in 1 BOTTLESPRAY, METERED722
72657-159-72Fluticasone PropionateALLERGY RELIEF1 in 1 CARTONSPRAY, METERED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-159-12ML - Milliliter72657-1593d2ebf15-b646-4fe8-9f0f-a8165943c9d212026-04-20
72657-159-14ML - Milliliter72657-15906d254c1-b66a-4bcf-bf2c-02b69ed8d95712026-04-20
72657-159-28ML - Milliliter72657-1590ceda1bd-2f45-45da-9142-d46656e0171312026-04-20
72657-159-72ML - Milliliter72657-159d2b6ce8b-ed4d-4ac9-930f-7bdf6a172a9912026-04-20

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
Fluticasone Propionate ALLERGY RELIEFFLUTICASONE PROPIONATEGLENMARK THERAPEUTICS INC., USA5494106f-6792-409e-b63f-b63b981409592026-05-05WarningsExact identifier
application applno (ANDA): 218742
application number: ANDA218742
ndc (package): 72657-159-36
ndc (product): 72657-159
ndc11 (package): 72657015936

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN5494106f-6792-409e-b63f-b63b981409592
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD5494106f-6792-409e-b63f-b63b981409592
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY5494106f-6792-409e-b63f-b63b981409592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72657-159-36726570159363 BOTTLE in 1 CARTON (72657-159-36) / 120 SPRAY, METERED in 1 BOTTLE3 bottle2026-03-16NoNoCurrent