Sunmark Miconazole 7

Product NDC: 49348-530
11-digit product format: 493480530
Labeler code: 49348
Product ID: 49348-530_c271896e-5b14-4589-85d9-55fa7b0e57b7
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole nitrate
Dosage form: CREAM
Route: VAGINAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA074760
Marketing category: ANDA
Marketing start: 2003-07-31
Marketing end: 0000-00-00
Substance: MICONAZOLE NITRATE
Active strength: 2 g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49348-530		D	Discontinued by firm		2026-08-07
excluded package	package	49348-530	49348-530-77	D	Discontinued by firm		2026-08-07

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
A074760-001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	2%	CREAM / VAGINAL			1997-05-15

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	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074760-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-05-15	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-530-77	GM - Gram	49348-530	cde6c188-aaeb-440d-be20-b51e491b7d41	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	SUNMARK MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [MCKESSON]	1
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	SUNMARK MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [MCKESSON]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49348-530	SUNMARK MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [STRATEGIC SOURCING SERVICES LLC]	6	Legacy NDC	20241225_8191186c-ba90-4c35-b40c-2944c2f49ee7.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense miconazole 7	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	9e0af5f8-249e-434a-a9c6-eb2f4045d9f6	2026-06-08	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
miconazole 7	MICONAZOLE NITRATE	HyVee Inc	53b9bcb3-ff43-4849-9f72-84febe255328	2026-06-04	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
MICONAZOLE 7	MICONAZOLE NITRATE	Safeway	2f19d76f-1348-483e-8720-612d30928bb5	2026-05-26	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Miconazole 7	MICONAZOLE NITRATE	Meijer Distribution Inc	b8417956-4c53-444e-823a-a87748eb0a08	2026-05-05	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
up and up miconazole 7	MICONAZOLE NITRATE	Target Corporation	b6216f21-4af8-40ab-8151-a9367a42b82c	2025-07-17	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
vagisil brand vagistat	MICONAZOLE NITRATE	Combe Incorporated	833a5e4d-0591-4300-8f9c-fd00ffaf6041	2025-04-15	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
miconazole 7	MICONAZOLE NITRATE	H E B	9741b8c0-716a-4c54-9793-387866faf766	2023-11-13	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
foster and thrive miconazole 7	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	b06590b5-1dcf-47b7-8e81-5887b1c3893a	2023-11-05	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
foster and thrive miconazole	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	09c4f6c9-ba51-47f4-95b4-d236fa45778b	2023-10-25	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Miconazole 7	MICONAZOLE NITRATE	Kroger Company	9fc3df65-c441-44ab-aaac-f63b565ca2f5	2023-09-13	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Equaline Miconazole 7	MICONAZOLE NITRATE	United Natural Foods, Inc. dba UNFI	7ebd51d9-8578-48c8-804a-e80fbe514fa1	2023-08-02	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Basic Care Miconazole 7	MICONAZOLE NITRATE	Amazon.com Services LLC	4a828083-f5a9-46c3-a07a-3d151f155025	2021-08-13	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
DG Health Miconazole	MICONAZOLE NITRATE	Dolgencorp, LLC	12a36975-ebfe-4fcb-a9de-981a21325632	2021-06-09	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Topcare Miconazole 7	MICONAZOLE NITRATE	Topco Associates LLC	351905b1-f78c-4838-a036-23b2bfc775f2	2021-02-08	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
signature care miconazole 7	MICONAZOLE NITRATE	Safeway	2e04ac2d-cfbc-4261-a8f9-03715f819c1c	2021-02-08	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Good Neighbor Pharmacy Miconazole 7	MICONAZOLE NITRATE	Amerisource Bergen	5a3441e8-f4fc-404f-8e9e-6d2aee2b8cec	2021-01-27	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Good Sense Miconazole 7	MICONAZOLE NITRATE	L Perrigo Company	4902029e-47dd-483b-af03-b1b5936e98ea	2021-01-27	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
good sense miconazole 7	MICONAZOLE NITRATE	L. Perrigo Company	090ee644-7f73-4a43-aa5e-bfa74b0d5130	2021-01-06	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760
Careone miconazole 7	MICONAZOLE NITRATE	American Sales Company	fced0f7f-31b8-4975-836e-3f38c496a450	2021-01-06	Warnings	Exact identifier application applno (ANDA): 074760 application number: ANDA074760

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	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-530-77	49348053077	1 TUBE, WITH APPLICATOR in 1 CARTON (49348-530-77) > 45 g in 1 TUBE, WITH APPLICATOR	2003-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Miconazole 7 Drug Facts	Strategic Sourcing Services LLC	2024-12-23	HUMAN OTC DRUG LABEL	6