XHANCE

Product NDC: 71143-375
Requested package NDC: 71143-375-01
11-digit product format: 711430375
Labeler code: 71143
Product ID: 71143-375_4650025f-0f79-6a7b-e063-6294a90ab7f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluticasone propionate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: OptiNose US, Inc.
Application: NDA209022
Marketing category: NDA
Marketing start: 2017-10-03
Marketing end: 2028-07-31
Substance: FLUTICASONE PROPIONATE
Active strength: 93 ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209022-001	XHANCE	FLUTICASONE PROPIONATE	0.093MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2017-09-18

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N209022-001	12083270	2031-04-04	U-2133	2024-10-02
N209022-001	11554229	2036-02-23	U-2133	2023-02-08
N209022-001	12616806	2036-02-23	U-4524	2026-05-29
N209022-001	12616806	2036-02-23	U-4525	2026-05-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209022-001	I-940	2027-03-15

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209022-001	XHANCE	0.093MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209022-001	XHANCE	0.093MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209022-001	XHANCE	0.093MG	SPRAY, METERED / NASAL	RLD, RS	2017-09-18	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 555 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209022-001	12083270	2031-04-04	U-2133		2024-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209022-001	11554229	2036-02-23	U-2133		2023-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209022-001	12616806	2036-02-23	U-4524		2026-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209022-001	12616806	2036-02-23	U-4525		2026-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209022-001	12083270	2031-04-04	U-2133		2024-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209022-001	11554229	2036-02-23	U-2133		2023-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209022-001	12616806	2036-02-23	U-4524		2026-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209022-001	12616806	2036-02-23	U-4525		2026-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209022-001	12083270	2031-04-04	U-2133		2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209022-001	11554229	2036-02-23	U-2133		2023-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209022-001	12083270	2031-04-04	U-2133		2024-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209022-001	11554229	2036-02-23	U-2133		2023-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209022-001	7975690	2025-12-29	U-2133		2017-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	10124132	2027-03-06	U-2133	Drug product	2018-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	11602603	2028-10-27	U-2133	Drug product	2023-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	10076615	2029-07-30	U-2133		2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	8550073	2029-10-22		Drug product	2017-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	8978647	2030-12-06		Drug product	2017-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	10252010	2031-02-07		Drug product	2019-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	12083270	2031-04-04	U-2133		2024-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	11033696	2033-05-20		Drug product	2021-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	10179216	2033-07-08	U-2133	Drug product	2019-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	10478574	2033-11-04	U-2133		2019-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	10076614	2034-10-20		Drug product	2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	10300229	2035-07-07	U-2133	Drug product	2019-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209022-001	11554229	2036-02-23	U-2133		2023-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	7975690	2025-12-29	U-2133		2017-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	10124132	2027-03-06	U-2133	Drug product	2018-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	11602603	2028-10-27	U-2133	Drug product	2023-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	10076615	2029-07-30	U-2133		2018-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	8550073	2029-10-22		Drug product	2017-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	8978647	2030-12-06		Drug product	2017-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	10252010	2031-02-07		Drug product	2019-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	12083270	2031-04-04	U-2133		2024-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	11033696	2033-05-20		Drug product	2021-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	10179216	2033-07-08	U-2133	Drug product	2019-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	10478574	2033-11-04	U-2133		2019-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	10076614	2034-10-20		Drug product	2018-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	10300229	2035-07-07	U-2133	Drug product	2019-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	11554229	2036-02-23	U-2133		2023-02-08	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N209022-001	I-940	2027-03-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209022-001	I-940	2027-03-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209022-001	I-940	2027-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209022-001	I-940	2027-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209022-001	I-940	2027-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209022-001	I-940	2027-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209022-001	I-940	2027-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209022-001	I-940	2027-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209022-001	I-940	2027-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209022-001	I-940	2027-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209022-001	I-940	2027-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209022-001	I-940	2027-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209022-001	I-940	2027-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209022-001	I-940	2027-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209022-001	I-940	2027-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209022-001	I-940	2027-03-15	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	N209022-001	NP	2020-09-18	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N209022-001	NP	2020-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209022-001	NP	2020-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209022-001	NP	2020-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209022-001	NP	2020-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209022-001	NP	2020-09-18	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209022-001	I-940	2027-03-15	`a50c72e98297…`

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: XHANCE

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUTICASONE PROPIONATE	93 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
1946583	Internal RxNorm lookup
1946589	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
c79bbb9f-e483-4093-8c92-ea978e7bf278	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	SPL version
71143-375-01	XHANCE	120 in 1 BOTTLE	SPRAY, METERED	120	18
71143-375-01	XHANCE	1 in 1 CARTON	SPRAY, METERED	1	18
71143-375-98	XHANCE	28 in 1 BOTTLE	SPRAY, METERED	28	18
71143-375-98	XHANCE	1 in 1 CARTON	SPRAY, METERED	1	18
71143-375-99	XHANCE	1 in 1 CARTON	SPRAY, METERED	1	18
71143-375-99	XHANCE	120 in 1 BOTTLE	SPRAY, METERED	120	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71143-375-01	ML - Milliliter	71143-375	ebe6c1f8-467a-4e16-ae6b-b5293ff7829c	1	2017-11-06
71143-375-99	ML - Milliliter	71143-375	36911206-afb3-4a17-bdf5-e34130b56a9a	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71143-375	XHANCE (FLUTICASONE PROPIONATE) SPRAY, METERED [OPTINOSE US, INC.]	16	Current NDC, Legacy NDC, 6 package rows	20241103_c79bbb9f-e483-4093-8c92-ea978e7bf278.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XHANCE	FLUTICASONE PROPIONATE	Paratek Pharmaceuticals, Inc.	44fcea33-8cfa-3a5c-e063-6394a90aafb2	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209022 application number: NDA209022
XHANCE	FLUTICASONE PROPIONATE	OptiNose US, Inc.	c79bbb9f-e483-4093-8c92-ea978e7bf278	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209022 application number: NDA209022 ndc (package): 71143-375-01 ndc (product): 71143-375 ndc11 (package): 71143037501

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
1946583	fluticasone propionate 93 MCG/ACTUAT Metered Dose Nasal Spray	PSN	c79bbb9f-e483-4093-8c92-ea978e7bf278	18
1946589	XHANCE 93 MCG/ACTUAT Metered Dose Nasal Spray	PSN	c79bbb9f-e483-4093-8c92-ea978e7bf278	18
1946589	fluticasone propionate 0.093 MG/ACTUAT Metered Dose Nasal Spray [Xhance]	SBD	c79bbb9f-e483-4093-8c92-ea978e7bf278	18
1946583	fluticasone propionate 0.093 MG/ACTUAT Metered Dose Nasal Spray	SCD	c79bbb9f-e483-4093-8c92-ea978e7bf278	18
1946583	fluticasone propionate 93 MCG/ACTUAT Metered Dose Nasal Spray	SY	c79bbb9f-e483-4093-8c92-ea978e7bf278	18
1946589	Xhance 0.093 MG/ACTUAT Metered Dose Nasal Spray	SY	c79bbb9f-e483-4093-8c92-ea978e7bf278	18
1946589	Xhance 93 MCG/ACTUAT Metered Dose Nasal Spray	SY	c79bbb9f-e483-4093-8c92-ea978e7bf278	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71143-375-01	71143037501	1 BOTTLE in 1 CARTON (71143-375-01) / 120 SPRAY, METERED in 1 BOTTLE	1 bottle	2017-10-03	2028-07-31	No	No	Current