Fluocinonide

Product NDC
45802-151
Requested package NDC
45802-151-96
11-digit product format
458020151
Labeler code
45802
Product ID
45802-151_72c72409-e1bc-4058-8957-4361d7f94d22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA090256
Marketing category
ANDA
Marketing start
2014-01-14
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage45802-15145802-151-96DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45802-15145802-151-96DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45802-15145802-151-96DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090256-001FLUOCINONIDEFLUOCINONIDE0.1%CREAM / TOPICAL2014-01-14

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-143f01610625f2…
2019-09-15 20:21 UTC2019-09A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090256-001FLUOCINONIDE0.1%CREAM / TOPICAL2014-01-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090256-001FLUOCINONIDE0.1%CREAM / TOPICALAB2014-01-14e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090256-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090256-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090256-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090256-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090256-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090256-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090256-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090256-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090256-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090256-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090256-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090256-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090256-001AB1ea99ee380514…
2023-12-20 04:57 UTC2023-12A090256-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090256-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090256-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090256-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090256-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090256-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090256-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090256-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090256-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090256-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090256-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-151-94Fluopar1 in 1 CARTONCREAM1 mg in 1g5
45802-151-94Fluopar30 g in 1 TUBECREAM30 g1 mg in 1g5
45802-151-94Fluocinol Pak1 in 1 CARTONCREAM1 mg in 1g4
45802-151-94Fluocinol Pak30 g in 1 TUBECREAM30 g1 mg in 1g4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-151-53GM - Gram45802-1512f23ca90-e048-4a7a-bf90-aed5a0098c4512014-02-04
45802-151-94GM - Gram45802-1514854416e-88e8-4fbb-9c24-824a1377f2ab12014-02-04
45802-151-96GM - Gram45802-151bfe9b540-5012-446b-84d7-8c7cc8ac8fbf12014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluocinonideACTIVE INGREDIENT2W4A77YPANFLUOCINONIDE CREAM [PERRIGO NEW YORK INC]3
FluocinonideACTIVE MOIETY2W4A77YPANFLUOCINONIDE CREAM [PERRIGO NEW YORK INC]3
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EFLUOCINONIDE CREAM [PERRIGO NEW YORK INC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFLUOCINONIDE CREAM [PERRIGO NEW YORK INC]3
DIISOPROPANOLAMINEINACTIVE INGREDIENT0W44HYL8T5FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLUOCINONIDE CREAM [PERRIGO NEW YORK INC]3
GLYCERYL 1-STEARATEINACTIVE INGREDIENT258491E1RZFLUOCINONIDE CREAM [PERRIGO NEW YORK INC]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]3
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]3
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RFLUOCINONIDE CREAM [PERRIGO NEW YORK INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]3
WATERINACTIVE INGREDIENT059QF0KO0RFLUOCINONIDE CREAM [PERRIGO NEW YORK INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-151FLUOPAR (FLUOCINONIDE, DIMETHICONE) KIT [PURETEK CORPORATION]5Legacy NDC20241215_9ff7fa78-0fca-976f-e053-2995a90a4641.zip
45802-151FLUOCINOL PAK (FLUOCINONIDE) KIT [PURETEK CORPORATION]4Legacy NDC20230112_a9c88a41-3ff8-78f7-e053-2995a90adb8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259090dimethicone 5 % Topical CreamPSN9ff7fa78-0fca-976f-e053-2995a90a46415
485647fluocinonide 0.1 % Topical CreamPSN9ff7fa78-0fca-976f-e053-2995a90a46415
259090dimethicone 50 MG/ML Topical CreamSCD9ff7fa78-0fca-976f-e053-2995a90a46415
485647fluocinonide 1 MG/ML Topical CreamSCD9ff7fa78-0fca-976f-e053-2995a90a46415
259090dimethicone 5 % Topical CreamSY9ff7fa78-0fca-976f-e053-2995a90a46415
485647fluocinonide 0.1 % Topical CreamSY9ff7fa78-0fca-976f-e053-2995a90a46415
485647fluocinonide 1 MG per 1 GM Topical CreamSY9ff7fa78-0fca-976f-e053-2995a90a46415
485647fluocinonide 0.1 % Topical CreamPSNa9c88a41-3ff8-78f7-e053-2995a90adb8f4
485647fluocinonide 1 MG/ML Topical CreamSCDa9c88a41-3ff8-78f7-e053-2995a90adb8f4
485647fluocinonide 0.1 % Topical CreamSYa9c88a41-3ff8-78f7-e053-2995a90adb8f4
485647fluocinonide 1 MG per 1 GM Topical CreamSYa9c88a41-3ff8-78f7-e053-2995a90adb8f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-151-96458020151961 TUBE in 1 CARTON (45802-151-96) > 60 g in 1 TUBE1 tube2014-01-140000-00-00NoNoCurrent