Home NDC 0713-0223 Fluocinolone Acetonide
Product NDC 0713-0223
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.
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 2024-11-08 22:44 UTC · 2 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…2026-08-01 22:54:32 2026-06 A089526-001 FLUOCINOLONE ACETONIDE 0.01% CREAM / TOPICAL AT 1988-07-26 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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 0713-0223-15 00713022315 1 TUBE in 1 CARTON (0713-0223-15) / 15 g in 1 TUBE 1 tube 1988-07-26 0000-00-00 No No Current 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