Miconazole

Product NDC: 37808-928
11-digit product format: 378080928
Labeler code: 37808
Product ID: 37808-928_6b7d09f4-b857-4e61-9541-2a143bd5a8ee
Type: HUMAN OTC DRUG
Nonproprietary name: miconazole nitrate
Dosage form: CREAM
Route: VAGINAL
Labeler: H E B
Application: ANDA091366
Marketing category: ANDA
Marketing start: 2020-03-17
Substance: MICONAZOLE NITRATE
Active strength: 40 mg/g
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 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	40 mg/g

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998544	Internal RxNorm lookup
2288429	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
83305fd6-2154-4b1b-aaec-3e2e56708fdb	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37808-928-14	Miconazole	1 in 1 CARTON	CREAM	1		3
37808-928-14	Miconazole	5 g in 1 TUBE	CREAM	5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-928	MICONAZOLE (MICONAZOLE NITRATE) CREAM [H E B]	3	Current NDC, Legacy NDC, 2 package rows	20210216_83305fd6-2154-4b1b-aaec-3e2e56708fdb.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 · 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 ndc (product): 37808-928

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2288429	{3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } Pack	GPCK	83305fd6-2154-4b1b-aaec-3e2e56708fdb	3
2288429	miconazole 4 % Vaginal Cream 3-Day Applicator Pack	PSN	83305fd6-2154-4b1b-aaec-3e2e56708fdb	3
998544	miconazole nitrate 4 % Vaginal Cream	PSN	83305fd6-2154-4b1b-aaec-3e2e56708fdb	3
998544	miconazole nitrate 40 MG/ML Vaginal Cream	SCD	83305fd6-2154-4b1b-aaec-3e2e56708fdb	3
2288429	miconazole 4 % 3-Day Prefilled Applicator Pack	SY	83305fd6-2154-4b1b-aaec-3e2e56708fdb	3
998544	miconazole nitrate 4 % Vaginal Cream	SY	83305fd6-2154-4b1b-aaec-3e2e56708fdb	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-928-14	37808092814	1 TUBE in 1 CARTON (37808-928-14) / 5 g in 1 TUBE	1 tube	2020-03-17	0000-00-00	No	No	Current