Image Essentials Miconazole Treatment

Product NDC: 49738-599
11-digit product format: 497380599
Labeler code: 49738
Product ID: 49738-599_63790f1f-8fac-4c46-b734-867c80d308b4
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole nitrate
Dosage form: KIT
Labeler: Kmart Corporation
Application: ANDA076357
Marketing category: ANDA
Marketing start: 2015-02-04
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2019-12-31
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	49738-599		D	Discontinued by firm		2026-08-11
excluded package	package	49738-599	49738-599-00	D	Discontinued by firm		2026-08-11

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	49738-599-00	`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	49738-599-00	`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	49738-599-00	`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	49738-599-00	`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	49738-599-00	`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	49738-599-00	`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	49738-599-00	`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	49738-599-00	`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	49738-599-00	`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	49738-599-00	`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	49738-599-00	`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	49738-599-00	`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
A076357-001	MICONAZOLE 3 COMBINATION PACK	MICONAZOLE NITRATE	2%,4%	CREAM / TOPICAL, VAGINAL			2004-03-30

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	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076357-001	MICONAZOLE 3 COMBINATION PACK	2%,4%	CREAM / TOPICAL, VAGINAL	2004-03-30	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
PEG-5 OLEATE	INACTIVE INGREDIENT	0240V77G50	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
PEGOXOL 7 STEARATE	INACTIVE INGREDIENT	3EW5AXE5X5	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	IMAGE ESSENTIALS MICONAZOLE TREATMENT (MICONAZOLE NITRATE) KIT [KMART CORPORATION]	3

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 3	MICONAZOLE NITRATE	Rite Aid Corporation	78b6ac87-3de0-44e9-9e28-b4c7ab028fd5	2026-07-07	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357
Miconazole 3	MICONAZOLE NITRATE	Meijer Distribution Inc	c915a495-8eac-4a1a-83a4-c874682433c8	2026-05-07	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357
Rugby Miconazole 3	MICONAZOLE NITRATE	Rugby Laboratories	2d7035fa-9695-4d66-89f5-bd26420450ef	2026-02-25	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357
Up and Up Miconazole 3	MICONAZOLE NITRATE	Target Corporation	9a186532-ee69-428e-98a9-8ee69f4d667a	2026-01-30	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357
foster and thrive miconazole 3	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	4c536e07-5e88-4bdd-a5b2-10226d5486ed	2025-12-16	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357
Leader Miconazole 3	MICONAZOLE NITRATE	Cardinal Health 110, LLC. dba Leader	7f6df893-f404-4b2d-ab2b-696c8a2d36fa	2025-09-29	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357
Miconazole 3	MICONAZOLE NITRATE	CVS Pharmacy	9f506f59-e435-465d-90c7-9b0edc44160d	2025-04-24	Warnings	Exact identifier application applno (ANDA): 076357 application number: ANDA076357

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kmart Corporation Miconazole Treatment Drug Facts	Kmart Corporation	2015-06-16	HUMAN OTC DRUG LABEL	3