Naftifine hydrochloride

Product NDC: 70700-161
11-digit product format: 707000161
Labeler code: 70700
Product ID: 70700-161_7ad13433-2f93-1881-5fe6-2e0630ac70fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naftifine hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Xiromed, LLC
Application: ANDA210038
Marketing category: ANDA
Marketing start: 2021-01-15
Marketing end: 0000-00-00
Substance: NAFTIFINE HYDROCHLORIDE
Active strength: 20 mg/g
Pharmacologic classes: Allylamine [CS],Allylamine Antifungal [EPC]
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	70700-161		I	Inactivated by FDA	2026-08-17
excluded package	package	70700-161	70700-161-17	I	Inactivated by FDA	2026-08-17
excluded package	package	70700-161	70700-161-18	I	Inactivated by FDA	2026-08-17

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
A210038-001	NAFTIFINE HYDROCHLORIDE	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB		2020-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210038-001	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
2026-08-18 06:07:40	2026-07	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210038-001	NAFTIFINE HYDROCHLORIDE	2.0%	CREAM / TOPICAL	AB	2020-09-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210038-001	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	2020-09-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210038-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210038-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210038-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210038-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210038-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210038-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210038-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210038-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210038-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210038-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210038-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210038-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210038-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210038-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210038-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210038-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210038-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210038-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210038-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210038-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210038-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210038-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210038-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210038-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210038-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210038-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210038-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210038-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210038-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210038-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210038-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210038-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210038-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210038-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210038-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210038-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210038-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210038-001	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8f630d5a-8a28-4ac5-8ede-8b54b7617055	Product name	3	20210512
6aca302d-6492-4ac9-8829-e023cb64c91c	Product name	1	20190627
ba2e3195-29b1-b94a-4345-149632e97b51	Product name	3	20161117
7ac69d99-c06d-0e83-7872-6229bc9878f9	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70700-161-17	Naftifine hydrochloride	1 in 1 CARTON	CREAM	1	1
70700-161-17	Naftifine hydrochloride	60 g in 1 TUBE	CREAM	60	1
70700-161-18	Naftifine hydrochloride	1 in 1 CARTON	CREAM	1	1
70700-161-18	Naftifine hydrochloride	45 g in 1 TUBE	CREAM	45	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70700-161-17	GM - Gram	70700-161	5c13bb34-4d65-4cef-aec1-60521abc0600	1	2022-03-09
70700-161-18	GM - Gram	70700-161	82cf22ba-9cfb-4269-822b-c5daba58e07a	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70700-161	NAFTIFINE HYDROCHLORIDE CREAM [XIROMED, LLC]	1	Legacy NDC, 4 package rows	20210116_567f7418-e65c-740f-6233-741f5274fe1c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
25UR9N9041	NAFTIFINE HYDROCHLORIDE	65473-14-5	NAFTIFINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1246096	naftifine HCl 2 % Topical Cream	PSN	567f7418-e65c-740f-6233-741f5274fe1c	1
1246096	naftifine hydrochloride 20 MG/ML Topical Cream	SCD	567f7418-e65c-740f-6233-741f5274fe1c	1
1246096	naftifine hydrochloride 2 % Topical Cream	SY	567f7418-e65c-740f-6233-741f5274fe1c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70700-161-17	70700016117	1 TUBE in 1 CARTON (70700-161-17) > 60 g in 1 TUBE	1 tube	2021-01-15	0000-00-00	No	No	Current
70700-161-18	70700016118	1 TUBE in 1 CARTON (70700-161-18) > 45 g in 1 TUBE	1 tube	2021-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naftifine hydrochloride	Xiromed, LLC \| Xiromed Pharma España, S.L.	2021-01-15	HUMAN PRESCRIPTION DRUG LABEL	1