Fluocinonide topical solution USP, 0.05%

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 21:18:24

Label at a glance#

ProductFluocinonide

Active ingredientFLUOCINONIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1375-8

Fluocinonide topical solution USP, 0.05%

Rx only

20 mL

Fluocinonide topical solution USP, 0.05%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310364	fluocinonide 0.05 % Topical Solution	PSN	5
310364	fluocinonide 0.5 MG/ML Topical Solution	SCD	5
310364	fluocinonide 0.05 % Topical Solution	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FLUOCINONIDE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70771-1375-3	Fluocinonide	60 mL in 1 BOTTLE	SOLUTION	60		5
70771-1375-8	Fluocinonide	20 mL in 1 BOTTLE	SOLUTION	20		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1375	FLUOCINONIDE SOLUTION [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20241201_72b19e31-49e8-4bd7-8205-997f0c6a43f1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Fluocinonide
ALCOHOL
CITRIC ACID MONOHYDRATE
DIISOPROPYL ADIPATE
PROPYLENE GLYCOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1375	70771-1375-8, 70771-1375-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FLUOCINONIDE	2W4A77YPAN	ACTIB
ALCOHOL	3K9958V90M	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
DIISOPROPYL ADIPATE	P7E6YFV72X	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A208948-001	FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT		2018-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A208948-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208948-001	FLUOCINONIDE	0.05%	SOLUTION / TOPICAL	AT	2018-07-17	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A208948-001	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208948-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208948-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208948-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208948-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208948-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208948-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208948-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208948-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208948-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208948-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208948-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208948-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208948-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208948-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208948-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208948-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208948-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208948-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208948-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208948-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208948-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208948-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208948-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208948-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208948-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208948-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208948-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208948-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208948-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208948-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208948-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208948-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208948-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208948-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208948-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208948-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208948-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208948-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208948-001	AT	1	`3a93d1ddd44b…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluocinonide	FLUOCINONIDE	Zydus Lifesciences Limited	72b19e31-49e8-4bd7-8205-997f0c6a43f1	2024-11-30		Exact identifier ndc (package): 70771-1375-8 ndc (package): 70771-1375-3 ndc (product): 70771-1375 ndc11 (package): 70771137503 ndc11 (package): 70771137508 spl id: 1a414d04-9c98-460f-8c89-93b98698206e spl set id: 72b19e31-49e8-4bd7-8205-997f0c6a43f1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.