FLUOCINONIDE CREAM

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-08-16
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 21:10:55

Label at a glance#

ProductFLUOCINONIDE

Active ingredientFLUOCINONIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1393-2

Fluocinonide Cream USP, 0.1%

Rx only

30 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
485647	fluocinonide 0.1 % Topical Cream	PSN	4
485647	fluocinonide 1 MG/ML Topical Cream	SCD	4
485647	fluocinonide 0.1 % Topical Cream	SY	4
485647	fluocinonide 1 MG per 1 GM Topical Cream	SY	4

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
de14082b-1b4a-48ac-b75c-4ee3ff8a29be	Product name	1	20180809
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1393-2	FLUOCINONIDE	30 g in 1 TUBE	CREAM	30	4
70771-1393-3	FLUOCINONIDE	60 g in 1 TUBE	CREAM	60	4
70771-1393-5	FLUOCINONIDE	120 g in 1 TUBE	CREAM	120	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1393	FLUOCINONIDE CREAM [ZYDUS LIFESCIENCES LIMITED]	4	Current NDC, Legacy NDC, 3 package rows	20240821_08d69d3f-c628-4b08-a7ae-0f7ec5599d3a.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

FLUOCINONIDE
ANHYDROUS CITRIC ACID
CARBOMER HOMOPOLYMER TYPE C
DIETHYLENE GLYCOL MONOETHYL ETHER
DIISOPROPANOLAMINE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
PROPYLENE GLYCOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1393	70771-1393-2, 70771-1393-3, 70771-1393-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FLUOCINONIDE	2W4A77YPAN	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
CARBOMER HOMOPOLYMER TYPE C	4Q93RCW27E	IACT
DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	IACT
DIISOPROPANOLAMINE	0W44HYL8T5	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	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 43.

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
A208989-001	FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB		2020-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208989-001	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208989-001	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	2020-02-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208989-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208989-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208989-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208989-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208989-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208989-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208989-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208989-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208989-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208989-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208989-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208989-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208989-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208989-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208989-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208989-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208989-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208989-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208989-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208989-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208989-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208989-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208989-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208989-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208989-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208989-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208989-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208989-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208989-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208989-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208989-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208989-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208989-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208989-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208989-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208989-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208989-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208989-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208989-001	AB	1	`a50c72e98297…`

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	08d69d3f-c628-4b08-a7ae-0f7ec5599d3a	2024-08-16		Exact identifier ndc (package): 70771-1393-2 ndc (package): 70771-1393-3 ndc (package): 70771-1393-5 ndc (product): 70771-1393 ndc11 (package): 70771139302 ndc11 (package): 70771139303 ndc11 (package): 70771139305 spl id: 785b93c3-9489-4d35-9dc5-5f64d5c604ee spl set id: 08d69d3f-c628-4b08-a7ae-0f7ec5599d3a

Reported adverse events (FAERS/openFDA)#

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