Fluocinonide

Product NDC: 45802-151
Requested package NDC: 45802-151-94
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	45802-151	45802-151-94	D	Discontinued by firm		2026-08-11

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 date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45802-151	45802-151-94	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45802-151	45802-151-94	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A090256-001	FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM / TOPICAL			2014-01-14

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL		2014-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090256-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2014-01-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090256-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090256-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090256-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090256-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090256-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090256-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090256-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090256-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090256-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090256-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090256-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090256-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090256-001	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A090256-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090256-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090256-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090256-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090256-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090256-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090256-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090256-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090256-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090256-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090256-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
a338afdd-91bc-4c45-5113-8b445b8e6cf2	Product name	5	20200618
f3bf4e6e-291f-4372-8e90-b4047949153a	Product name	3	20200514
934e8c63-e34a-6dfb-4224-efad2d76fafc	Product name	5	20190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfe	Product name	1	20181219
ef1d202f-16bf-4f17-a390-087db27f5314	Product name	1	20181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29be	Product name	1	20180809
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-151-94	Fluopar	1 in 1 CARTON	CREAM		1 mg in 1g	5
45802-151-94	Fluopar	30 g in 1 TUBE	CREAM	30 g	1 mg in 1g	5
45802-151-94	Fluocinol Pak	1 in 1 CARTON	CREAM		1 mg in 1g	4
45802-151-94	Fluocinol Pak	30 g in 1 TUBE	CREAM	30 g	1 mg in 1g	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-151-53	GM - Gram	45802-151	2f23ca90-e048-4a7a-bf90-aed5a0098c45	1	2014-02-04
45802-151-94	GM - Gram	45802-151	4854416e-88e8-4fbb-9c24-824a1377f2ab	1	2014-02-04
45802-151-96	GM - Gram	45802-151	bfe9b540-5012-446b-84d7-8c7cc8ac8fbf	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fluocinonide	ACTIVE INGREDIENT	2W4A77YPAN	FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]	3
Fluocinonide	ACTIVE MOIETY	2W4A77YPAN	FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]	3
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]	3
DIISOPROPANOLAMINE	INACTIVE INGREDIENT	0W44HYL8T5	FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]	3
GLYCERYL 1-STEARATE	INACTIVE INGREDIENT	258491E1RZ	FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]	3
ISOSTEARIC ACID	INACTIVE INGREDIENT	X33R8U0062	FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]	3
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLUOCINONIDE CREAM [PERRIGO NEW YORK INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-151	FLUOPAR (FLUOCINONIDE, DIMETHICONE) KIT [PURETEK CORPORATION]	5	Legacy NDC	20241215_9ff7fa78-0fca-976f-e053-2995a90a4641.zip
45802-151	FLUOCINOL PAK (FLUOCINONIDE) KIT [PURETEK CORPORATION]	4	Legacy NDC	20230112_a9c88a41-3ff8-78f7-e053-2995a90adb8f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluopar	FLUOCINONIDE, DIMETHICONE	PureTek Corporation	9ff7fa78-0fca-976f-e053-2995a90a4641	2024-12-13	Warnings, Adverse reactions	Exact identifier ndc (package): 45802-151-94 ndc11 (package): 45802015194
Fluocinol Pak	FLUOCINONIDE	PureTek Corporation	a9c88a41-3ff8-78f7-e053-2995a90adb8f	2023-01-11	Warnings, Adverse reactions	Exact identifier ndc (package): 45802-151-94 ndc11 (package): 45802015194

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2W4A77YPAN	FLUOCINONIDE	356-12-7	FLUOCINONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
259090	dimethicone 5 % Topical Cream	PSN	9ff7fa78-0fca-976f-e053-2995a90a4641	5
485647	fluocinonide 0.1 % Topical Cream	PSN	9ff7fa78-0fca-976f-e053-2995a90a4641	5
259090	dimethicone 50 MG/ML Topical Cream	SCD	9ff7fa78-0fca-976f-e053-2995a90a4641	5
485647	fluocinonide 1 MG/ML Topical Cream	SCD	9ff7fa78-0fca-976f-e053-2995a90a4641	5
259090	dimethicone 5 % Topical Cream	SY	9ff7fa78-0fca-976f-e053-2995a90a4641	5
485647	fluocinonide 0.1 % Topical Cream	SY	9ff7fa78-0fca-976f-e053-2995a90a4641	5
485647	fluocinonide 1 MG per 1 GM Topical Cream	SY	9ff7fa78-0fca-976f-e053-2995a90a4641	5
485647	fluocinonide 0.1 % Topical Cream	PSN	a9c88a41-3ff8-78f7-e053-2995a90adb8f	4
485647	fluocinonide 1 MG/ML Topical Cream	SCD	a9c88a41-3ff8-78f7-e053-2995a90adb8f	4
485647	fluocinonide 0.1 % Topical Cream	SY	a9c88a41-3ff8-78f7-e053-2995a90adb8f	4
485647	fluocinonide 1 MG per 1 GM Topical Cream	SY	a9c88a41-3ff8-78f7-e053-2995a90adb8f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-151-94	45802015194	1 TUBE in 1 CARTON (45802-151-94) > 30 g in 1 TUBE	1 tube	2014-01-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluopar	PureTek Corporation \| Perrigo New York Inc	2024-12-13	HUMAN PRESCRIPTION DRUG LABEL	5
fluocinonide cream, zinc oxide, silicone tape	Primary Pharmaceuticals, Inc.	2024-01-17	HUMAN PRESCRIPTION DRUG LABEL	3
Fluocinonide	Padagis Israel Pharmaceuticals Ltd	2023-03-01	HUMAN PRESCRIPTION DRUG LABEL	9
Fluocinol Pak	PureTek Corporation	2023-01-11	HUMAN PRESCRIPTION DRUG LABEL	4
fluocinonide cream, silicone roll, self-adhesive wrap	Primary Pharmaceuticals, Inc.	2021-01-13	HUMAN PRESCRIPTION DRUG LABEL	2
Hexicinide	PureTek Corporation \| Xttrium Laboratories, Inc. \| Perrigo New York Inc	2020-03-16	HUMAN PRESCRIPTION DRUG LABEL	2
Fluocinonide	Preferred Pharmaceuticals Inc.	2019-09-23	HUMAN PRESCRIPTION DRUG LABEL	2
Fluocinonide	Quality Care Products, LLC	2019-03-20	HUMAN PRESCRIPTION DRUG LABEL	2
Fluocinonide	REMEDYREPACK INC.	2017-11-17	HUMAN PRESCRIPTION DRUG LABEL	1