basic care miconazole 3

Product NDC: 0113-7070
11-digit product format: 001137070
Labeler code: 0113
Product ID: 0113-7070_38f76beb-1cb7-4734-a393-9da28e7f1cc9
Type: HUMAN OTC DRUG
Nonproprietary name: miconazole nitrate
Dosage form: CREAM
Route: VAGINAL
Labeler: L. Perrigo Company
Application: ANDA091366
Marketing category: ANDA
Marketing start: 2018-11-07
Marketing end: 0000-00-00
Substance: MICONAZOLE NITRATE
Active strength: 40 mg/g
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	0113-7070		D	Discontinued by firm		2026-08-10
excluded package	package	0113-7070	0113-7070-14	D	Discontinued by firm		2026-08-10

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 · 24 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	0113-7070-14	`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	0113-7070-14	`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	0113-7070-14	`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	0113-7070-14	`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	0113-7070-14	`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	0113-7070-14	`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	0113-7070-14	`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	0113-7070-14	`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	0113-7070-14	`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	0113-7070-14	`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	0113-7070-14	`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	0113-7070-14	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A091366-001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	4%	CREAM / VAGINAL			2010-01-15

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`cb3db0bc1861…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GOOD SENSE MICONAZOLE 3	MICONAZOLE NITRATE	L. Perrigo Company	906dcf48-63d8-44cf-a699-d1f30c84a029	2025-11-29	Warnings	Exact identifier application applno (ANDA): 091366 application number: ANDA091366
miconazole 3	MICONAZOLE NITRATE	Walgreen Company	0600418d-77ec-4f2d-a08e-1bf5ec634904	2025-01-27	Warnings	Exact identifier application applno (ANDA): 091366 application number: ANDA091366
basic care miconazole 3	MICONAZOLE NITRATE	Amazon.com Services LLC	e1457c13-6d35-41b2-b1e8-7e82b647a0c7	2021-07-26	Warnings	Exact identifier application applno (ANDA): 091366 application number: ANDA091366
HERS Miconazole 3	MICONAZOLE NITRATE	Hims Inc	1b2a36fb-48dd-451e-a804-c864be4e5326	2021-03-04	Warnings	Exact identifier application applno (ANDA): 091366 application number: ANDA091366
Topco Miconazole 3	MICONAZOLE NITRATE	Topco Associates LLC	aef7be88-3cd7-484b-96a3-e9bbeca55e2a	2021-02-10	Warnings	Exact identifier application applno (ANDA): 091366 application number: ANDA091366
Miconazole	MICONAZOLE NITRATE	H E B	83305fd6-2154-4b1b-aaec-3e2e56708fdb	2021-02-09	Warnings	Exact identifier application applno (ANDA): 091366 application number: ANDA091366

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VW4H1CYW1K	MICONAZOLE NITRATE	22832-87-7	MICONAZOLE NITRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0113-7070-14	00113707014	3 APPLICATOR in 1 CARTON (0113-7070-14) > 5 g in 1 APPLICATOR	3 applicator	2018-11-07	0000-00-00	No	No	Current