Miconazole 7

Product NDC: 69842-988
11-digit product format: 698420988
Labeler code: 69842
Product ID: 69842-988_362a5224-f51c-e0fc-e063-6394a90ad176
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: CREAM
Route: VAGINAL
Labeler: CVS Pharmacy
Application: ANDA074444
Marketing category: ANDA
Marketing start: 1997-01-13
Substance: MICONAZOLE NITRATE
Active strength: 20 mg/100g
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
A074444-001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	2%	CREAM / VAGINAL			1997-01-13

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Miconazole 7
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	20 mg/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VW4H1CYW1K	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
5e7e4cf8-24ec-486e-9389-546ffea004d0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-03-13	Miconazole 7
2023-01-30	Miconazole 7
2021-04-05	Miconazole 7
2021-01-29	Miconazole 7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69842-988-07	Miconazole 7	45 g in 1 TUBE, WITH APPLICATOR	CREAM	45		7
69842-988-07	Miconazole 7	1 in 1 CARTON	CREAM	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-988	MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [CVS PHARMACY]	7	Current NDC, Legacy NDC, 2 package rows	20250529_5e7e4cf8-24ec-486e-9389-546ffea004d0.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole Nitrate	MICONAZOLE NITRATE	Sun Pharmaceutical Industries, Inc.	6b34d0be-4bcd-4dff-b732-7fbd46765019	2026-08-25	Warnings	Exact identifier application applno (ANDA): 074444 application number: ANDA074444
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	a32fc37b-bcad-4f56-8dc6-cf36a6716196	2026-02-19	Warnings	Exact identifier application applno (ANDA): 074444 application number: ANDA074444
Miconazole 7	MICONAZOLE NITRATE	TARGET Corporation	edaca770-bc76-4ac2-bad2-cf8e7de0c682	2025-05-27	Warnings	Exact identifier application applno (ANDA): 074444 application number: ANDA074444
Miconazole 7	MICONAZOLE NITRATE	CVS Pharmacy	5e7e4cf8-24ec-486e-9389-546ffea004d0	2025-05-27	Warnings	Exact identifier application applno (ANDA): 074444 application number: ANDA074444 ndc (product): 69842-988

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
69842-988-07	69842098807	1 TUBE, WITH APPLICATOR in 1 CARTON (69842-988-07) / 45 g in 1 TUBE, WITH APPLICATOR	2016-12-15	0000-00-00	No	No	Current