Home NDC 36800-222 topcare fluticasone propionate nasal
Product NDC 36800-222
11-digit product format 368000222
Labeler code 36800
Product ID 36800-222_343d4087-6c6d-430a-a927-d1c0cedf420e
Type HUMAN OTC DRUG
Nonproprietary name Fluticasone propionate
Dosage form SPRAY, METERED
Route NASAL
Labeler Topco Associates LLC
Application ANDA207957
Marketing category ANDA
Marketing start 2016-06-24
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 A207957-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26
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 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-05-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207957-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL RS 2016-05-26 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base topcare fluticasone propionate nasal
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797907 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-222-01 topcare fluticasone propionate nasal 1 in 1 CARTON SPRAY, METERED 1 5 36800-222-01 topcare fluticasone propionate nasal 120 in 1 BOTTLE SPRAY, METERED 120 5 36800-222-03 topcare fluticasone propionate nasal 2 in 1 CARTON SPRAY, METERED 2 5 36800-222-03 topcare fluticasone propionate nasal 120 in 1 BOTTLE SPRAY, METERED 120 5 36800-222-09 topcare fluticasone propionate nasal 1 in 1 CARTON SPRAY, METERED 1 5 36800-222-09 topcare fluticasone propionate nasal 144 in 1 BOTTLE SPRAY, METERED 144 5 36800-222-10 topcare fluticasone propionate nasal 144 in 1 BOTTLE SPRAY, METERED 144 5 36800-222-10 topcare fluticasone propionate nasal 2 in 1 CARTON SPRAY, METERED 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-222 TOPCARE FLUTICASONE PROPIONATE NASAL (FLUTICASONE PROPIONATE) SPRAY, METERED [TOPCO ASSOCIATES LLC] 5 Current NDC, Legacy NDC, 8 package rows 20221102_f7c425d2-4afb-478f-83bc-eb336910233b.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 3 · 42 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-222-01 36800022201 1 BOTTLE in 1 CARTON (36800-222-01) / 120 SPRAY, METERED in 1 BOTTLE 1 bottle 2016-06-24 0000-00-00 No No Current 36800-222-03 36800022203 2 BOTTLE in 1 CARTON (36800-222-03) / 120 SPRAY, METERED in 1 BOTTLE 2 bottle 2017-10-19 0000-00-00 No No Current 36800-222-09 36800022209 1 BOTTLE in 1 CARTON (36800-222-09) / 144 SPRAY, METERED in 1 BOTTLE 1 bottle 2021-05-26 0000-00-00 No No Current 36800-222-10 36800022210 2 BOTTLE in 1 CARTON (36800-222-10) / 144 SPRAY, METERED in 1 BOTTLE 2 bottle 2021-05-26 0000-00-00 No No Current