miconazole 3

Product NDC: 37808-242
11-digit product format: 378080242
Labeler code: 37808
Product ID: 37808-242_5a63c87d-9f46-4ddc-b662-a0ec944d7798
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole nitrate
Dosage form: KIT
Labeler: H E B
Application: ANDA075329
Marketing category: ANDA
Marketing start: 2006-03-14
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
A075329-001	MICONAZOLE NITRATE COMBINATION PACK	MICONAZOLE NITRATE	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL			1999-04-20

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	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
miconazole 3	MICONAZOLE NITRATE	Kroger Company	063153cc-00fd-4390-bc68-90b21203678a	2026-02-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
dg health miconazole 3	MICONAZOLE NITRATE	Dolgencorp Inc	d84aa78d-b408-4d51-a54c-c66f6cef33f1	2025-11-01	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Miconazole 3	MICONAZOLE NITRATE	Safeway	b32aec61-32c0-4c7f-b843-348243332583	2025-11-01	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
VAGISTAT 3	MICONAZOLE NITRATE	Combe Incorporated	e15a28cd-9e64-4e9e-8df9-829d84f1816c	2025-11-01	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
miconazole 3	MICONAZOLE NITRATE	H E B	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	2025-10-31	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 37808-242
CareOne Miconazole 3	MICONAZOLE NITRATE	American Sales Company	84c43793-98e4-4e68-a3bc-3e7222135568	2025-10-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Miconazole 3	MICONAZOLE NITRATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	689ad530-48f9-4044-baa3-4f8b0657aeef	2025-10-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Equate Miconazole 3	MICONAZOLE NITRATE	WALMART INC.	5ade4c65-5757-4f20-b5be-f95d86363d11	2025-09-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Equaline Miconazole 3	MICONAZOLE NITRATE	United Natural Foods, Inc. dba UNFI	89328324-72d9-4b3d-bec7-cc2e4e62f034	2025-09-18	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
miconazole 3 day	MICONAZOLE NITRATE	Publix Super Markets Inc	9ff23f06-e97f-46ad-8601-97ca05c260a0	2025-09-16	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
topcare miconazole 3 combination pack	MICONAZOLE NITRATE	Topco Associates LLC	0af4c06a-aa79-48ab-9857-e0f56317d8f3	2025-09-16	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
miconazole 3	MICONAZOLE NITRATE	Meijer Distribution Inc	feaa0d07-013e-433f-8db4-550dc9ff737e	2025-09-11	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Foster and Thrive Miconazole 3	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	ba5d5b13-5604-4b8c-92b9-9f4174458029	2025-08-12	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Good Neighbor Pharmacy Miconazole 3	MICONAZOLE NITRATE	Amerisource Bergen	5b87b837-3f52-40ca-b2b6-9c1f1262d90d	2025-06-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Good Sense Miconazole 3	MICONAZOLE NITRATE	L. Perrigo Company	9aeac709-001b-4617-8046-186264847ec8	2025-05-15	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
miconazole 3	MICONAZOLE NITRATE	Rite Aid Corporation	4abee369-e8c5-4971-9545-8c015ff6eaad	2023-11-08	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Signature Care Miconazole 3	MICONAZOLE NITRATE	Safeway	191e448b-0410-4102-82ae-a3387b27b227	2021-02-04	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329

Additional Listing Data#

Finished product: Yes
Brand name base: miconazole 3
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992765	Internal RxNorm lookup
992766	Internal RxNorm lookup
998483	Internal RxNorm lookup
998540	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
f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	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
37808-242-00	miconazole 3	1 in 1 CARTON	KIT	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]	1
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]	1
COTTONSEED OIL	INACTIVE INGREDIENT	H3E878020N	MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]	1
PEG-5 OLEATE	INACTIVE INGREDIENT	0240V77G50	MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]	1
PEGOXOL 7 STEARATE	INACTIVE INGREDIENT	3EW5AXE5X5	MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-242	MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [H E B]	4	Current NDC, Legacy NDC, 1 package rows	20210424_f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6.zip

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
992766	{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } Pack	GPCK	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	5
998483	miconazole nitrate 2 % Topical Cream	PSN	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	5
998540	miconazole nitrate 2 % Vaginal Cream	PSN	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	5
992765	miconazole nitrate 200 MG Vaginal Insert	PSN	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	5
992766	miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) Pack	PSN	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	5
998483	miconazole nitrate 20 MG/ML Topical Cream	SCD	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	5
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	5
992765	miconazole nitrate 200 MG Vaginal Insert	SCD	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	5
992766	miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)	SY	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	5
992766	miconazole 3 Day Vaginal Insert Combination Pack	SY	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	5
998483	miconazole nitrate 2 % Topical Cream	SY	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	5
998540	miconazole nitrate 2 % Vaginal Cream	SY	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-242-00	37808024200	1 KIT in 1 CARTON (37808-242-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE	1 kit	2006-03-14	0000-00-00	No	No	Current