Home NDC 0713-0223-60 Fluocinolone Acetonide
Product NDC 0713-0223
Requested package NDC 0713-0223-60
11-digit product format 007130223
Labeler code 0713
Product ID 0713-0223_0abbbbe6-b694-1260-e063-6294a90a6f81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinolone Acetonide
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA089526
Marketing category ANDA
Marketing start 1988-07-26
Substance FLUOCINOLONE ACETONIDE
Active strength .1 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 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 A089526-001 FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089526-001 AT
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 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fluocinolone Acetonide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOCINOLONE ACETONIDE .1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0CD5FD6S2M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191256 Internal RxNorm lookup 1191302 Internal RxNorm lookup 1191315 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 0713-0223-15 Fluocinolone Acetonide 15 g in 1 TUBE CREAM 15 18 0713-0223-15 Fluocinolone Acetonide 1 in 1 CARTON CREAM 1 18 0713-0223-60 Fluocinolone Acetonide 1 in 1 CARTON CREAM 1 18 0713-0223-60 Fluocinolone Acetonide 60 g in 1 TUBE CREAM 60 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Fluocinolone Acetonide ACTIVE INGREDIENT 0CD5FD6S2M FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Fluocinolone Acetonide ACTIVE MOIETY 0CD5FD6S2M FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Isopropyl Palmitate INACTIVE INGREDIENT 8CRQ2TH63M FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Lanolin Alcohols INACTIVE INGREDIENT 884C3FA9HE FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Light Mineral Oil INACTIVE INGREDIENT N6K5787QVP FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Mineral Oil INACTIVE INGREDIENT T5L8T28FGP FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Polyoxyl 40 Stearate INACTIVE INGREDIENT 13A4J4NH9I FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Propylene Glycol Stearate INACTIVE INGREDIENT MZM1I680W0 FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Sorbic Acid INACTIVE INGREDIENT X045WJ989B FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Sorbitan Monostearate INACTIVE INGREDIENT NVZ4I0H58X FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10 Water INACTIVE INGREDIENT 059QF0KO0R FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0223 FLUOCINOLONE ACETONIDE CREAM FLUOCINOLONE ACETONIDE OINTMENT [COSETTE PHARMACEUTICALS, INC.] 18 Current NDC, Legacy NDC, 4 package rows 20231123_de5b78ab-ff79-3e0f-cad4-ecab11ebbdcd.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 0713-0223-60 00713022360 1 TUBE in 1 CARTON (0713-0223-60) / 60 g in 1 TUBE 1 tube 1988-07-26 0000-00-00 No No Current