Ertaczo

Product NDC: 0187-5115
11-digit product format: 001875115
Labeler code: 0187
Product ID: 0187-5115_c5d11596-8c13-483a-93f9-f7016fb8c663
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertaconazole Nitrate
Dosage form: CREAM
Route: TOPICAL
Labeler: Bausch Health US, LLC
Application: NDA021385
Marketing category: NDA
Marketing start: 2003-12-10
Marketing end: 0000-00-00
Substance: SERTACONAZOLE NITRATE
Active strength: 20 mg/g
Pharmacologic classes: Azole Antifungal [EPC],Azoles [CS]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0187-5115		D	Discontinued by firm	2026-08-17
excluded package	package	0187-5115	0187-5115-02	D	Discontinued by firm	2026-08-17
excluded package	package	0187-5115	0187-5115-60	D	Discontinued by firm	2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021385-001	ERTACZO	SERTACONAZOLE NITRATE	2%	CREAM / TOPICAL		RLD, RS	2003-12-10

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021385-001	ERTACZO	2%	CREAM / TOPICAL	RLD, RS	2003-12-10	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-5115-60	GM - Gram	0187-5115	95aeb7fc-8b86-412d-987f-0c0ffe444ccb	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sertaconazole Nitrate	ACTIVE INGREDIENT	1DV05410M5	ERTACZO (SERTACONAZOLE NITRATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Sertaconazole	ACTIVE MOIETY	72W71I16EG	ERTACZO (SERTACONAZOLE NITRATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Ethylene Glycol	INACTIVE INGREDIENT	FC72KVT52F	ERTACZO (SERTACONAZOLE NITRATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Glyceryl Isostearate	INACTIVE INGREDIENT	HYE7O27HAO	ERTACZO (SERTACONAZOLE NITRATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Light Mineral Oil	INACTIVE INGREDIENT	N6K5787QVP	ERTACZO (SERTACONAZOLE NITRATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	ERTACZO (SERTACONAZOLE NITRATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Sorbic Acid	INACTIVE INGREDIENT	X045WJ989B	ERTACZO (SERTACONAZOLE NITRATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6
Water	INACTIVE INGREDIENT	059QF0KO0R	ERTACZO (SERTACONAZOLE NITRATE) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-5115	ERTACZO (SERTACONAZOLE NITRATE) CREAM [BAUSCH HEALTH US, LLC]	14	Legacy NDC	20210507_821073f7-33f6-464d-baed-f66d97987d6d.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
Ertaczo	SERTACONAZOLE NITRATE	Coral Way Pharma, LLC	c6fa8dc4-2620-474e-a9b4-6657d9cbfa96	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021385 application number: NDA021385
Ertaczo	SERTACONAZOLE NITRATE	Lacer Pharma, LLC	27d51f01-3282-34ea-e063-6394a90a91ed	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021385 application number: NDA021385

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1DV05410M5	SERTACONAZOLE NITRATE	99592-39-9	SERTACONAZOLE NITRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-5115-60	00187511560	1 TUBE in 1 CARTON (0187-5115-60) > 60 g in 1 TUBE	1 tube	2003-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ertaczo	Bausch Health US, LLC \| DPT Laboratories, Ltd.	2020-12-18	HUMAN PRESCRIPTION DRUG LABEL	14