FLUTICARE

Product NDC: 57483-180
11-digit product format: 574830180
Labeler code: 57483
Product ID: 57483-180_38944633-aed4-4136-ab93-335d250d4e87
Type: HUMAN OTC DRUG
Nonproprietary name: fluticasone propionate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: INNOVUS PHARMACEUTICALS, INC.
Application: ANDA217088
Marketing category: ANDA
Marketing start: 2025-02-28
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217088-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL			2024-05-10

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217088-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2024-05-10	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: FLUTICARE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUTICASONE PROPIONATE	50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O2GMZ0LF5W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1797907	Internal RxNorm lookup
1996212	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
fed545ab-6a85-4ce3-8651-370e279db49e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33	Product name	3	20260126
343e8617-eb68-1e10-cfa9-8c30af285764	Product name	3	20240513
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
a31ad3df-8021-2ea1-94eb-0fe2f49b7729	Product name	4	20220719
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
813fe018-3e3c-40e4-8f71-7ab50f3dfe81	Product name	2	20180723
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
3bcd721e-0555-4bc3-96c6-690471ff9d94	Product name	1	20171113
9f9452df-fa34-43d4-97fe-c6605344c5a8	Product name	1	20171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202	Product name	1	20170426
f3c5232f-03de-44f5-996a-90cd9c08bc60	Product name	1	20170426
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1cb17fbb-0da4-2841-37bc-e7079783e1a2	Product name	1	20140508
667f427a-8698-a508-767a-53ed61b4c2e9	Product name	1	20140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9	Product name	1	20140508
6df84e13-2223-fa46-1e26-17e2f58a1e1c	Product name	1	20140508
90fec588-984c-4375-cfd4-7e40114bdf80	Product name	1	20140508
9c1d3c48-b162-204b-f55b-e0f25c31c52e	Product name	1	20140508
9fdb6139-394b-1510-4baf-bde68c419789	Product name	1	20140508
aef26912-037b-9a4e-db49-225ef6dfd8f1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57483-180-01	FLUTICARE	120 in 1 BOTTLE	SPRAY, METERED	120	3
57483-180-11	FLUTICARE	1 in 1 CARTON	SPRAY, METERED	1	3
57483-180-12	FLUTICARE	2 in 1 CARTON	SPRAY, METERED	2	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57483-180	FLUTICARE (FLUTICASONE PROPIONATE) SPRAY, METERED [INNOVUS PHARMACEUTICALS, INC.]	1	Current NDC, 3 package rows	20250305_fed545ab-6a85-4ce3-8651-370e279db49e.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Family Dollar Stores, LLC	4dd65267-9905-4f45-e063-6294a90a2516	2026-06-17	Warnings	Exact identifier application applno (ANDA): 217088 application number: ANDA217088
Mucinex Nasal Congestion and Allergy Relief	FLUTICASONE PROPIONATE	Reckitt Benckiser LLC	47d8bb65-0bff-f24d-e063-6394a90affaf	2026-05-20	Warnings	Exact identifier application applno (ANDA): 217088 application number: ANDA217088
365 WHOLE FOODS MARKET FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Whole Foods Market, Inc.	313517bd-cb08-49a5-8ef1-e5522cc21c80	2026-01-22	Warnings	Exact identifier application applno (ANDA): 217088 application number: ANDA217088
CHILDRENS FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Aurohealth LLC	180ef101-dca6-496f-8376-63449d82d083	2025-12-08	Warnings	Exact identifier application applno (ANDA): 217088 application number: ANDA217088
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Aurohealth LLC	044a06a1-74fc-43ff-b136-37ad41220941	2025-12-08	Warnings	Exact identifier application applno (ANDA): 217088 application number: ANDA217088
FLUTICARE	FLUTICASONE PROPIONATE	INNOVUS PHARMACEUTICALS, INC.	fed545ab-6a85-4ce3-8651-370e279db49e	2025-07-16	Warnings	Exact identifier application applno (ANDA): 217088 application number: ANDA217088 ndc (product): 57483-180

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O2GMZ0LF5W	FLUTICASONE PROPIONATE	80474-14-2	FLUTICASONE PROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1996212	FlutiCare 50 MCG/ACTUAT Metered Dose Nasal Spray	PSN	fed545ab-6a85-4ce3-8651-370e279db49e	3
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	PSN	fed545ab-6a85-4ce3-8651-370e279db49e	3
1996212	fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Fluticare]	SBD	fed545ab-6a85-4ce3-8651-370e279db49e	3
1797907	fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray	SCD	fed545ab-6a85-4ce3-8651-370e279db49e	3
1996212	Fluticare 0.05 MG/ACTUAT Metered Dose Nasal Spray	SY	fed545ab-6a85-4ce3-8651-370e279db49e	3
1996212	Fluticare 50 MCG/ACTUAT Metered Dose Nasal Spray	SY	fed545ab-6a85-4ce3-8651-370e279db49e	3
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	SY	fed545ab-6a85-4ce3-8651-370e279db49e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
57483-180-01	57483018001	120 in 1 BOTTLE					Historical
57483-180-11	57483018011	1 BOTTLE in 1 CARTON (57483-180-11) / 120 SPRAY, METERED in 1 BOTTLE (57483-180-01)	1 bottle	2025-02-28	No	No	Current
57483-180-12	57483018012	2 BOTTLE in 1 CARTON (57483-180-12) / 120 SPRAY, METERED in 1 BOTTLE (57483-180-01)	2 bottle	2025-06-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluticasone Propionate Nasal Spray USP, 50 mcg per spray	INNOVUS PHARMACEUTICALS, INC. \| Aurohealth LLC \| APL HEALTHCARE LIMITED	2025-07-16	Human OTC Drug Label	3