Fluocinolone Acetonide

Product NDC: 52565-012
11-digit product format: 525650012
Labeler code: 52565
Product ID: 52565-012_088e8303-2f51-470d-86ec-dcfcee267650
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinolone Acetonide
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: NDA015296
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2012-11-27
Marketing end: 0000-00-00
Substance: FLUOCINOLONE ACETONIDE
Active strength: 0 mg/mL
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52565-012		I	Inactivated by FDA		2026-08-11
excluded package	package	52565-012	52565-012-59	I	Inactivated by FDA		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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52565-012-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52565-012-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52565-012-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52565-012-59	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52565-012-59	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52565-012-59	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52565-012-59	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52565-012-59	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52565-012-59	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52565-012-59	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52565-012-59	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52565-012-59	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52565-012-59	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52565-012-59	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52565-012-59	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52565-012-59	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52565-012-59	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52565-012-59	`bd6a592717d7…`	`303034d00443…`

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
N015296-001	SYNALAR	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N015296-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N015296-001	SYNALAR	0.01%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N015296-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N015296-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N015296-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N015296-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N015296-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N015296-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N015296-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N015296-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N015296-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N015296-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N015296-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N015296-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N015296-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N015296-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N015296-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N015296-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N015296-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N015296-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N015296-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N015296-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N015296-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N015296-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N015296-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N015296-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N015296-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N015296-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N015296-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N015296-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N015296-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N015296-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N015296-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N015296-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N015296-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N015296-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N015296-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N015296-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N015296-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N015296-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N015296-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N015296-001	AT	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0adb2af5-1ecf-4df5-912b-16ae89228294	Product name	6	20240829
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
65f6255d-41cc-425f-ba54-b1bea4947886	Product name	5	20210930
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
5ba208e4-886f-44da-e218-ab4f4cad2c49	Product name	5	20190612
e5a2793f-318b-72fd-b734-c44ecc6f6748	Product name	2	20190213
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
9e453f34-aacb-44d5-a119-c0e3dc1fca2a	Product name	1	20160622
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
7df2570a-c555-4d82-9189-9247c722b62c	Product name	1	20150402
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508
a78a3633-fd06-b0af-63b3-c714de3b3bfa	Product name	1	20140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52565-012-59	2022-01-28	C162847	48780-1	d6a99b39-6940-a426-e053-dadaa90af4c2	Fluocinolone Acetonide Topical Solution USP, 0.01%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52565-012-59	Fluocinolone Acetonide	1 in 1 CARTON	SOLUTION	1		5
52565-012-59	Fluocinolone Acetonide	60 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	60		5
52565-012-59	NOXIPAK	1 in 1 CARTON	SOLUTION		0.1 mg in 1mL	2
52565-012-59	NOXIPAK	60 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	60 mL	0.1 mg in 1mL	2
52565-012-59	XILAPAK	60 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	60 mL	0.1 mg in 1mL	1
52565-012-59	XILAPAK	1 in 1 CARTON	SOLUTION		0.1 mg in 1mL	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-012-59	ML - Milliliter	52565-012	e73c8061-3edf-4c0e-93f3-e4144c8853bc	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fluocinolone Acetonide	ACTIVE INGREDIENT	0CD5FD6S2M	FLUOCINOLONE ACETONIDE SOLUTION [TELIGENT PHARMA, INC.]	3
Fluocinolone Acetonide	ACTIVE MOIETY	0CD5FD6S2M	FLUOCINOLONE ACETONIDE SOLUTION [TELIGENT PHARMA, INC.]	3
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	FLUOCINOLONE ACETONIDE SOLUTION [TELIGENT PHARMA, INC.]	3
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	FLUOCINOLONE ACETONIDE SOLUTION [TELIGENT PHARMA, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-012	FLUOCINOLONE ACETONIDE SOLUTION [TELIGENT PHARMA, INC.]	5	Legacy NDC, 2 package rows	20181017_b859bc63-a9e3-4a6d-a3f7-711b4eeaba63.zip
52565-012	NOXIPAK (FLUOCINOLONE ACETONIDE AND UREA) KIT [SOLUTECH PHARMACEUTICALS LLC]	2	Legacy NDC	20171109_136cb37e-e939-40b5-9725-194b14a9b090.zip
52565-012	XILAPAK (FLUOCINOLONE ACETONIDE) KIT [SOLUTECH PHARMACEUTICALS LLC]	1	Legacy NDC	20171104_f1b8a26a-dc63-4701-8a78-cc1f99fca1b3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0CD5FD6S2M	FLUOCINOLONE ACETONIDE	67-73-2	FLUOCINOLONE ACETONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1191310	fluocinolone acetonide 0.01 % Topical Solution	PSN	b859bc63-a9e3-4a6d-a3f7-711b4eeaba63	5
1191310	fluocinolone acetonide 0.1 MG/ML Topical Solution	SCD	b859bc63-a9e3-4a6d-a3f7-711b4eeaba63	5
1191310	fluocinolone acetonide 0.01 % Topical Solution	SY	b859bc63-a9e3-4a6d-a3f7-711b4eeaba63	5
1191310	fluocinolone acetonide 0.01 % Topical Solution	PSN	136cb37e-e939-40b5-9725-194b14a9b090	2
198886	urea 20 % Topical Cream	PSN	136cb37e-e939-40b5-9725-194b14a9b090	2
1191310	fluocinolone acetonide 0.1 MG/ML Topical Solution	SCD	136cb37e-e939-40b5-9725-194b14a9b090	2
198886	urea 200 MG/ML Topical Cream	SCD	136cb37e-e939-40b5-9725-194b14a9b090	2
1191310	fluocinolone acetonide 0.01 % Topical Solution	SY	136cb37e-e939-40b5-9725-194b14a9b090	2
198886	urea 17 GM in 85 GM Topical Cream	SY	136cb37e-e939-40b5-9725-194b14a9b090	2
198886	urea 20 % Topical Cream	SY	136cb37e-e939-40b5-9725-194b14a9b090	2
1191310	fluocinolone acetonide 0.01 % Topical Solution	PSN	f1b8a26a-dc63-4701-8a78-cc1f99fca1b3	1
1191310	fluocinolone acetonide 0.1 MG/ML Topical Solution	SCD	f1b8a26a-dc63-4701-8a78-cc1f99fca1b3	1
1191310	fluocinolone acetonide 0.01 % Topical Solution	SY	f1b8a26a-dc63-4701-8a78-cc1f99fca1b3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-012-59	52565001259	1 BOTTLE, WITH APPLICATOR in 1 CARTON (52565-012-59) > 60 mL in 1 BOTTLE, WITH APPLICATOR	2012-12-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NOXIPAK KIT	SOLUTECH PHARMACEUTICALS LLC	2017-11-08	HUMAN PRESCRIPTION DRUG LABEL	2
XILAPAK KIT	SOLUTECH PHARMACEUTICALS LLC	2017-11-02	HUMAN PRESCRIPTION DRUG LABEL	1
Fluocinolone Acetonide Topical Solution USP, 0.01%	Teligent Pharma, Inc.	2012-12-07	HUMAN PRESCRIPTION DRUG LABEL	5