Home NDC 51672-1253-4 Fluocinonide
Product NDC 51672-1253
Requested package NDC 51672-1253-4
11-digit product format 516721253
Labeler code 51672
Product ID 51672-1253_2b0274c4-7f1e-479c-a172-f1bd22c22797
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluocinonide
Dosage form CREAM
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application NDA019117
Marketing category NDA
Marketing start 1984-06-26
Marketing end 0000-00-00
Substance FLUOCINONIDE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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date N019117-001 FLUOCINONIDE FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26
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UTC 2026-02 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019117-001 FLUOCINONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1984-06-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL RLD 1984-06-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL RLD 1984-06-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL RLD 1984-06-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL RLD 1984-06-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL RLD 1984-06-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019117-001 FLUOCINONIDE 0.05% CREAM / TOPICAL AB1 RLD, RS 1984-06-26 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Fluocinonide ACTIVE INGREDIENT 2W4A77YPAN FLUOCINONIDE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 Fluocinonide ACTIVE INGREDIENT 2W4A77YPAN FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 Fluocinonide ACTIVE MOIETY 2W4A77YPAN FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 Fluocinonide ACTIVE MOIETY 2W4A77YPAN FLUOCINONIDE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 1,2,6-hexanetriol INACTIVE INGREDIENT W45XXM0XWE FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 1,2,6-hexanetriol INACTIVE INGREDIENT W45XXM0XWE FLUOCINONIDE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 carbomer homopolymer type c INACTIVE INGREDIENT 4Q93RCW27E FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP FLUOCINONIDE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 edetate disodium INACTIVE INGREDIENT 7FLD91C86K FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX FLUOCINONIDE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 mineral oil INACTIVE INGREDIENT T5L8T28FGP FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 petrolatum INACTIVE INGREDIENT 4T6H12BN9U FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 polyethylene glycol 3350 INACTIVE INGREDIENT G2M7P15E5P FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 polyethylene glycol 3350 INACTIVE INGREDIENT G2M7P15E5P FLUOCINONIDE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 polyethylene glycol 8000 INACTIVE INGREDIENT Q662QK8M3B FLUOCINONIDE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 polyethylene glycol 8000 INACTIVE INGREDIENT Q662QK8M3B FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 propyl gallate INACTIVE INGREDIENT 8D4SNN7V92 FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene carbonate INACTIVE INGREDIENT 8D08K3S51E FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINONIDE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y FLUOCINONIDE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 white wax INACTIVE INGREDIENT 7G1J5DA97F FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 Fluocinonide ACTIVE INGREDIENT 2W4A77YPAN FLUOCINONIDE CREAM [REBEL DISTRIBUTORS CORP] 1 Fluocinonide ACTIVE INGREDIENT 2W4A77YPAN FLUOCINONIDE CREAM [PROFICIENT RX LP] 1 Fluocinonide ACTIVE MOIETY 2W4A77YPAN FLUOCINONIDE CREAM [REBEL DISTRIBUTORS CORP] 1 Fluocinonide ACTIVE MOIETY 2W4A77YPAN FLUOCINONIDE CREAM [PROFICIENT RX LP] 1 1,2,6-hexanetriol INACTIVE INGREDIENT W45XXM0XWE FLUOCINONIDE CREAM [REBEL DISTRIBUTORS CORP] 1 1,2,6-hexanetriol INACTIVE INGREDIENT W45XXM0XWE FLUOCINONIDE CREAM [PROFICIENT RX LP] 1 citric acid INACTIVE INGREDIENT 2968PHW8QP FLUOCINONIDE CREAM [REBEL DISTRIBUTORS CORP] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP FLUOCINONIDE CREAM [PROFICIENT RX LP] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX FLUOCINONIDE CREAM [REBEL DISTRIBUTORS CORP] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX FLUOCINONIDE CREAM [PROFICIENT RX LP] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P FLUOCINONIDE CREAM [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P FLUOCINONIDE CREAM [PROFICIENT RX LP] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B FLUOCINONIDE CREAM [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B FLUOCINONIDE CREAM [PROFICIENT RX LP] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINONIDE CREAM [PROFICIENT RX LP] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 FLUOCINONIDE CREAM [REBEL DISTRIBUTORS CORP] 1 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y FLUOCINONIDE CREAM [REBEL DISTRIBUTORS CORP] 1 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y FLUOCINONIDE CREAM [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1253 FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 5 Legacy NDC, 8 package rows 20240823_b0bc89a9-c9d5-4adb-9785-2d4487c4c656.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 51672-1253-4 51672125304 1 TUBE in 1 CARTON (51672-1253-4) > 120 g in 1 TUBE 1 tube 1984-06-26 0000-00-00 No No Current