topcare miconazole 1

Product NDC: 36800-199
11-digit product format: 368000199
Labeler code: 36800
Product ID: 36800-199_aae0dcb7-6128-4681-b2c0-12be5aff38a1
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole nitrate
Dosage form: KIT
Labeler: Topco Associates LLC
Application: ANDA079114
Marketing category: ANDA
Marketing start: 2010-06-17
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
A079114-001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL			2010-06-02

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	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`cb3db0bc1861…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOSTER AND THRIVE MICONAZOLE 1	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	0d3fcb1a-54dd-49b7-b776-4366fc2147b3	2025-10-01	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
equate miconazole 1	MICONAZOLE NITRATE	Wal-Mart Stores Inc	5c5b0486-9ec2-4e14-a35c-80da8e62c59e	2025-07-02	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
miconazole 1	MICONAZOLE NITRATE	Meijer Distribution Inc	c34d9917-ee79-4afb-9338-6f18e63b2b09	2025-01-13	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
up and up miconazole	MICONAZOLE NITRATE	Target Corporation	b626313a-b8aa-43fe-b8a9-475009ea5b53	2024-12-11	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
miconazole 1	MICONAZOLE NITRATE	Kroger Company	11878a63-93e7-464f-97fc-54899884d7fe	2024-12-11	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
topcare miconazole 1	MICONAZOLE NITRATE	Topco Associates LLC	8138de63-c7e9-4b2c-a0e2-c62292a0b320	2024-12-11	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114 ndc (product): 36800-199
miconazole 1 yeast infection relief	MICONAZOLE NITRATE	CVS Pharmacy	b0e5320b-73d5-4e96-8ce4-9a858e9d2ed3	2024-12-10	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
Basic Care Miconazole	MICONAZOLE NITRATE	Amazon.com Services LLC	962bef75-1583-4782-bfba-52a68876eedc	2024-11-04	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
careone miconazole 1	MICONAZOLE NITRATE	American Sales Company	f51af8e2-fb06-4842-8021-b7efd515022e	2023-10-23	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
exchange select miconazole 1	MICONAZOLE NITRATE	Army & Air Force Exchange Service	672d935f-0807-44d1-8faa-94d416907095	2022-11-29	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
Signature Care Miconazole 1	MICONAZOLE NITRATE	Safeway	5129e042-421e-41e3-a0be-90f12d12b40b	2022-11-15	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
miconazole 1	MICONAZOLE NITRATE	H E B	40cc911b-2c35-4382-a979-fb1a165049db	2022-11-12	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
Good Neighbor Pharmacy Miconazole 1	MICONAZOLE NITRATE	Amerisource Bergen	12c400dc-4fbf-4a10-9a4d-5156d65b509a	2022-11-09	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114

Additional Listing Data#

Finished product: Yes
Brand name base: topcare miconazole 1
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
992774	Internal RxNorm lookup
992775	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
8138de63-c7e9-4b2c-a0e2-c62292a0b320	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
36800-199-00	topcare miconazole 1	1 in 1 CARTON	KIT	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-199-00	EA - Each	36800-199	69e80fea-1bee-42d9-aca0-4b5491a8f1e0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
PEG-5 OLEATE	INACTIVE INGREDIENT	0240V77G50	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
PEGOXOL 7 STEARATE	INACTIVE INGREDIENT	3EW5AXE5X5	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-199	TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]	8	Current NDC, Legacy NDC, 1 package rows	20241219_8138de63-c7e9-4b2c-a0e2-c62292a0b320.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
992775	{1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } Pack	GPCK	8138de63-c7e9-4b2c-a0e2-c62292a0b320	8
992775	miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) Pack	PSN	8138de63-c7e9-4b2c-a0e2-c62292a0b320	8
992774	miconazole nitrate 1200 MG Vaginal Insert	PSN	8138de63-c7e9-4b2c-a0e2-c62292a0b320	8
998483	miconazole nitrate 2 % Topical Cream	PSN	8138de63-c7e9-4b2c-a0e2-c62292a0b320	8
998540	miconazole nitrate 2 % Vaginal Cream	PSN	8138de63-c7e9-4b2c-a0e2-c62292a0b320	8
992774	miconazole nitrate 1200 MG Vaginal Insert	SCD	8138de63-c7e9-4b2c-a0e2-c62292a0b320	8
998483	miconazole nitrate 20 MG/ML Topical Cream	SCD	8138de63-c7e9-4b2c-a0e2-c62292a0b320	8
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	8138de63-c7e9-4b2c-a0e2-c62292a0b320	8
992774	miconazole nitrate 1.2 GM Vaginal Insert	SY	8138de63-c7e9-4b2c-a0e2-c62292a0b320	8
998483	miconazole nitrate 2 % Topical Cream	SY	8138de63-c7e9-4b2c-a0e2-c62292a0b320	8
998540	miconazole nitrate 2 % Vaginal Cream	SY	8138de63-c7e9-4b2c-a0e2-c62292a0b320	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-199-00	36800019900	1 KIT in 1 CARTON (36800-199-00) * 1 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE	1 kit	2010-06-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Miconazole 1 Drug Facts	Topco Associates LLC	2024-12-11	HUMAN OTC DRUG LABEL	8