Ecoza

Product NDC: 81811-100
Requested package NDC: 81811-100-70
11-digit product format: 818110100
Labeler code: 81811
Product ID: 81811-100_0bb5d729-5109-e387-e063-6394a90a1fce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: econazole nitrate
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: Resilia Pharmaceuticals, Inc.
Application: NDA205175
Marketing category: NDA
Marketing start: 2023-12-04
Substance: ECONAZOLE NITRATE
Active strength: 10 mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
N205175-001	ECOZA	ECONAZOLE NITRATE	1%	AEROSOL, FOAM / TOPICAL		RLD, RS	2013-10-24

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205175-001	10071054	2031-08-08		Drug product	2018-09-27

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	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205175-001	ECOZA	1%	AEROSOL, FOAM / TOPICAL	RLD, RS	2013-10-24	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205175-001	10071054	2031-08-08	Drug product	2018-09-27	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ecoza
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ECONAZOLE NITRATE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
H438WYN10E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1442585	Internal RxNorm lookup
1442590	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0bb5fa27-32ed-ed13-e063-6394a90a1577	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e3a04dc3-1a9e-4fba-b2b4-a18279351082	Product name	2	20180620
aa7deb41-117b-479c-8362-130fd1c222de	Product name	1	20160112

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81811-100-70	Ecoza	1 in 1 CARTON	AEROSOL, FOAM	1		1
81811-100-70	Ecoza	70 g in 1 CANISTER	AEROSOL, FOAM	70		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81811-100-70	GM - Gram	81811-100	d96c9f17-01ab-4e31-bc02-c24d582259ce	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81811-100	ECOZA (ECONAZOLE NITRATE) AEROSOL, FOAM [RESILIA PHARMACEUTICALS, INC.]	1	Current NDC, 2 package rows	20231219_0bb5fa27-32ed-ed13-e063-6394a90a1577.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
Econazole Nitrate	ECONAZOLE NITRATE	Trifluent Pharma, LLC	3eb40c94-f369-ce4b-e063-6294a90abed4	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205175 application number: NDA205175
Ecoza	ECONAZOLE NITRATE	Resilia Pharmaceuticals, Inc.	0bb5fa27-32ed-ed13-e063-6394a90a1577	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205175 application number: NDA205175 ndc (package): 81811-100-70 ndc (product): 81811-100 ndc11 (package): 81811010070

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H438WYN10E	ECONAZOLE NITRATE	24169-02-6	ECONAZOLE NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1442585	econazole nitrate 1 % Topical Foam	PSN	0bb5fa27-32ed-ed13-e063-6394a90a1577	1
1442590	ecoza 1 % Topical Foam	PSN	0bb5fa27-32ed-ed13-e063-6394a90a1577	1
1442590	econazole nitrate 10 MG/ML Topical Foam [Ecoza]	SBD	0bb5fa27-32ed-ed13-e063-6394a90a1577	1
1442585	econazole nitrate 10 MG/ML Topical Foam	SCD	0bb5fa27-32ed-ed13-e063-6394a90a1577	1
1442585	econazole nitrate 1 % Topical Foam	SY	0bb5fa27-32ed-ed13-e063-6394a90a1577	1
1442590	Ecoza 1 % Topical Foam	SY	0bb5fa27-32ed-ed13-e063-6394a90a1577	1
1442590	Ecoza 10 MG/ML Topical Foam	SY	0bb5fa27-32ed-ed13-e063-6394a90a1577	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81811-100-70	81811010070	1 CANISTER in 1 CARTON (81811-100-70) / 70 g in 1 CANISTER	1 canister	2023-12-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ecoza - Resilia Pharmaceuticals, Inc. \| DPT Laboratories, Ltd.	Resilia Pharmaceuticals, Inc. \| DPT Laboratories, Ltd.	2023-12-04	HUMAN PRESCRIPTION DRUG LABEL	1