Application 019452

Type: NDA
Sponsor: HILL DERMAC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DERMA-SMOOTHE/FS	FLUOCINOLONE ACETONIDE	OIL;TOPICAL	0.01%	Yes	Yes
002	DERMA-SMOOTHE/FS	FLUOCINOLONE ACETONIDE	OIL;TOPICAL	0.01%	Yes	Yes
003	DERMOTIC	FLUOCINOLONE ACETONIDE	OIL/DROPS;OTIC	0.01%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019452-001	DERMA-SMOOTHE/FS	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03
N019452-002	DERMA-SMOOTHE/FS	FLUOCINOLONE ACETONIDE	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09
N019452-003	DERMOTIC	FLUOCINOLONE ACETONIDE	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N019452-001	AT
N019452-002	AT
N019452-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019452-002	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	2005-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019452-003	DERMOTIC	0.01%	OIL/DROPS / OTIC	AT	RLD, RS	2005-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019452-001	DERMA-SMOOTHE/FS	0.01%	OIL / TOPICAL	AT	RLD, RS	1988-02-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N019452-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019452-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019452-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019452-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019452-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019452-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019452-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019452-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019452-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019452-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019452-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019452-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019452-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019452-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019452-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019452-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019452-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019452-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019452-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019452-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019452-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019452-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019452-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019452-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019452-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019452-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019452-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019452-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019452-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019452-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019452-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019452-002	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019452-003	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019452-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019452-002	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019452-003	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019452-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019452-002	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019452-003	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019452-001	AT	1	`8072bd15b7f6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Derma-Smoothe/FS	FLUOCINOLONE ACETONIDE	Royal Pharmaceuticals, LLC	bc61c619-a71c-46f5-80f1-9e9ee71134aa	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019452 application number: NDA019452 ndc (product): 68791-101
DERMA-SMOOTHE/FS	FLUOCINOLONE ACETONIDE	Royal Pharmaceuticals	113e167a-a9fe-440e-9446-d6d87963ef46	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019452 application number: NDA019452 ndc (product): 68791-102
DERMOTIC	FLUOCINOLONE ACETONIDE	Royal Pharmaceuticals	eb00f222-8105-4e05-90e8-bbd129784364	2025-05-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019452 application number: NDA019452 ndc (product): 68791-103

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13925-506	Fluocinolone Acetonide	fluocinolone acetonide	Seton Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
13925-507	Fluocinolone Acetonide	fluocinolone acetonide	Seton Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
13925-508	Fluocinolone acetonide 0.01%	fluocinolone acetonide	Seton Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68791-101	Derma-Smoothe/FS	fluocinolone acetonide	Royal Pharmaceuticals	NDA	Current
68791-101	Derma-Smoothe/FS	fluocinolone acetonide	Royal Pharmaceuticals	NDA	Current
68791-101	Derma-Smoothe/FS	fluocinolone acetonide	Royal Pharmaceuticals	NDA	Current
68791-102	Derma-Smoothe/FS	fluocinolone acetonide	Royal Pharmaceuticals	NDA	Current
68791-102	Derma-Smoothe/FS	fluocinolone acetonide	Royal Pharmaceuticals	NDA	Current
68791-102	Derma-Smoothe/FS	fluocinolone acetonide	Royal Pharmaceuticals	NDA	Current
68791-103	DermOtic	fluocinolone acetonide	Royal Pharmaceuticals	NDA	Current
68791-103	DermOtic	fluocinolone acetonide	Royal Pharmaceuticals	NDA	Current
68791-103	DermOtic	fluocinolone acetonide	Royal Pharmaceuticals	NDA	Current
68791-103	DermOtic	fluocinolone acetonide	Royal Pharmaceuticals	NDA	Current
68791-103	DermOtic	fluocinolone acetonide	Royal Pharmaceuticals	NDA	Current
68791-103	DermOtic	fluocinolone acetonide	Royal Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79529	SUPPL	2024-09-03
79522	SUPPL	2024-09-03
63488	SUPPL	2020-06-12
63432	SUPPL	2020-06-08
51066	SUPPL	2017-12-07
17407	SUPPL	2005-11-18
1330	SUPPL	2005-11-18
1327	SUPPL	2005-11-18
33750	SUPPL	2005-11-17
33749	SUPPL	2005-11-17
11506	SUPPL	2005-11-17
33748	SUPPL	2003-05-29
1329	SUPPL	2003-05-29
20244	SUPPL	2001-10-10
11507	SUPPL	2001-10-10
1328	SUPPL	2001-10-10
33747	SUPPL	1999-08-18
20243	SUPPL	1999-08-18
1326	SUPPL	1999-08-18
64237	ORIG	1900-01-01
64236	ORIG	1900-01-01
64235	ORIG	1900-01-01