Home NDC 0713-0631 Fluticasone Propionate
Product NDC 0713-0631
11-digit product format 007130631
Labeler code 0713
Product ID 0713-0631_de485a69-2992-143b-e053-2a95a90a4b89
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluticasone Propionate
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA077055
Marketing category ANDA
Marketing start 2006-06-30
Substance FLUTICASONE PROPIONATE
Active strength .5 mg/g
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 42 .
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 A077055-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077055-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077055-001 FLUTICASONE PROPIONATE 0.05% CREAM / TOPICAL AB 2006-06-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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/g
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 895987 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 0713-0631-15 Fluticasone Propionate 1 in 1 CARTON CREAM 1 11 0713-0631-15 Fluticasone Propionate 15 g in 1 TUBE CREAM 15 11 0713-0631-31 Fluticasone Propionate 1 in 1 CARTON CREAM 1 11 0713-0631-31 Fluticasone Propionate 30 g in 1 TUBE CREAM 30 11 0713-0631-60 Fluticasone Propionate 60 g in 1 TUBE CREAM 60 11 0713-0631-60 Fluticasone Propionate 1 in 1 CARTON CREAM 1 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Fluticasone Propionate ACTIVE INGREDIENT O2GMZ0LF5W FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Fluticasone ACTIVE MOIETY CUT2W21N7U FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Ceteth-20 INACTIVE INGREDIENT I835H2IHHX FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Cetostearyl Alcohol INACTIVE INGREDIENT 2DMT128M1S FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Isopropyl Myristate INACTIVE INGREDIENT 0RE8K4LNJS FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Mineral Oil INACTIVE INGREDIENT T5L8T28FGP FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Sodium Phosphate, Dibasic INACTIVE INGREDIENT GR686LBA74 FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Water INACTIVE INGREDIENT 059QF0KO0R FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [G&W LABORATORIES, INC.] 7 Fluticasone Propionate ACTIVE INGREDIENT O2GMZ0LF5W FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 FLUTICASONE ACTIVE MOIETY CUT2W21N7U FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Ceteth-20 INACTIVE INGREDIENT I835H2IHHX FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Cetostearyl Alcohol INACTIVE INGREDIENT 2DMT128M1S FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Isopropyl Myristate INACTIVE INGREDIENT 0RE8K4LNJS FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Mineral Oil INACTIVE INGREDIENT T5L8T28FGP FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Sodium Phosphate, Dibasic INACTIVE INGREDIENT GR686LBA74 FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4 Water INACTIVE INGREDIENT 059QF0KO0R FLUTICASONE PROPIONATE CREAM [DIRECT RX] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0631 FLUTICASONE PROPIONATE CREAM [COSETTE PHARMACEUTICALS, INC.] 11 Current NDC, Legacy NDC, 6 package rows 20220616_14c8d082-b301-8f09-a509-950459ae0a28.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.
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 0713-0631-15 00713063115 1 TUBE in 1 CARTON (0713-0631-15) / 15 g in 1 TUBE 1 tube 2006-06-30 0000-00-00 No No Current 0713-0631-31 00713063131 1 TUBE in 1 CARTON (0713-0631-31) / 30 g in 1 TUBE 1 tube 2006-06-30 0000-00-00 No No Current 0713-0631-60 00713063160 1 TUBE in 1 CARTON (0713-0631-60) / 60 g in 1 TUBE 1 tube 2006-06-30 0000-00-00 No No Current