fluticasone propionate

Product NDC: 45802-441
11-digit product format: 458020441
Labeler code: 45802
Product ID: 45802-441_8a4c8510-ac39-4d97-b713-7581de6a8f0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluticasone propionate
Dosage form: LOTION
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA091553
Marketing category: ANDA
Marketing start: 2013-08-08
Substance: FLUTICASONE PROPIONATE
Active strength: .5 mg/mL
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
A091553-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL		RS	2013-07-30

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL		RS	2013-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL		RS	2013-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091553-001	FLUTICASONE PROPIONATE	0.05%	LOTION / TOPICAL	AB		2013-07-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A091553-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091553-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091553-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091553-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091553-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091553-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091553-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091553-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091553-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091553-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091553-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091553-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091553-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091553-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091553-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091553-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091553-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091553-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091553-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091553-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091553-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091553-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091553-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091553-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091553-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091553-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091553-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091553-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091553-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091553-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091553-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091553-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091553-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091553-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091553-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091553-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091553-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091553-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUTICASONE PROPIONATE	.5 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
895990	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
c4d361d4-d480-4fb2-8cc7-4cc3e57838dc	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
a31ad3df-8021-2ea1-94eb-0fe2f49b7729	Product name	4	20220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81	Product name	2	20180723
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
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	Strength	SPL version
45802-441-02	fluticasone propionate	60 mL in 1 BOTTLE	LOTION	60		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-441-02	ML - Milliliter	45802-441	67b1fa72-92de-42e2-a659-34509cd87419	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUTICASONE PROPIONATE	ACTIVE INGREDIENT	O2GMZ0LF5W	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
FLUTICASONE	ACTIVE MOIETY	CUT2W21N7U	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLUTICASONE PROPIONATE LOTION [PERRIGO NEW YORK INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-441	FLUTICASONE PROPIONATE LOTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]	10	Current NDC, Legacy NDC, 1 package rows	20240809_c4d361d4-d480-4fb2-8cc7-4cc3e57838dc.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fluticasone propionate	FLUTICASONE PROPIONATE	Padagis Israel Pharmaceuticals Ltd	c4d361d4-d480-4fb2-8cc7-4cc3e57838dc	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091553 application number: ANDA091553 ndc (product): 45802-441

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
895990	fluticasone propionate 0.05 % Topical Lotion	PSN	c4d361d4-d480-4fb2-8cc7-4cc3e57838dc	10
895990	fluticasone propionate 0.5 MG/ML Topical Lotion	SCD	c4d361d4-d480-4fb2-8cc7-4cc3e57838dc	10
895990	fluticasone propionate 0.05 % Topical Lotion	SY	c4d361d4-d480-4fb2-8cc7-4cc3e57838dc	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-441-02	45802044102	60 mL in 1 BOTTLE (45802-441-02)	60 ml	2013-08-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
fluticasone propionate	Padagis Israel Pharmaceuticals Ltd	2024-05-01	HUMAN PRESCRIPTION DRUG LABEL	10