Anti-Fungal Powder

Product NDC: 51316-980
Requested package NDC: 51316-980-01
11-digit product format: 513160980
Labeler code: 51316
Product ID: 51316-980_5de7b8bb-8b67-cea5-e063-6294a90a2357
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: POWDER
Route: TOPICAL
Labeler: CVS Pharmacy
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-04-17
Substance: MICONAZOLE NITRATE
Active strength: 20 mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Anti-Fungal Powder
Listing expiration: 2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
51316-980-01	Anti-Fungal Powder	71 g in 1 BOTTLE, PLASTIC	POWDER	71		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-980	ANTI-FUNGAL POWDER (MICONAZOLE NITRATE) POWDER [CVS PHARMACY]	2	Current NDC, 1 package rows	20241207_1651bdd7-ab15-7a2d-e063-6294a90a8b91.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 39 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Cardinal Health 110 dba LEADER	34f4c733-2eb2-0db0-e063-6394a90a6431	2025-05-13	Warnings	Exact identifier application number: M005
Dr CANUSO fungal nail eraser	TOLNAFTATE OIL	Renu Laboratories, LLC	2083f9ed-09d6-26e6-e054-00144ff88e88	2025-05-13	Warnings	Exact identifier application number: M005
Dr. Canuso foot repair serum	TOLNAFTATE SERUM	Renu Laboratories, LLC	1fcc52c5-7030-13cb-e054-00144ff8d46c	2025-05-13	Warnings	Exact identifier application number: M005
Private Label Antifungal Barrier Cream	MICONAZOLE NITRATE ANTIFUNGAL CREAM	Swiss-American CDMO, LLC	2ee40c37-504b-43ed-960a-535015407492	2025-05-09	Warnings	Exact identifier application number: M005
Osimoon Fungal Nail Treatment Kit	OSIMOON FUNGAL NAIL TREATMENT KIT	Guangzhou Zanming Trading Co., Ltd.	34aec10d-a0d0-d956-e063-6394a90a39b2	2025-05-09	Warnings	Exact identifier application number: M005
ANTIFUNGAL	MICONAZOLE	VIVE HEALTH LLC	33d9c724-d4c4-2597-e063-6294a90aa5f3	2025-04-28	Warnings	Exact identifier application number: M005
ANTIFUNGAL	CLOTRIMAZOLE	VIVE HEALTH LLC	33db98f5-f6d9-742a-e063-6394a90a2a03	2025-04-28	Warnings	Exact identifier application number: M005
Foot Cure Nail Repair Pen	ANTIFUNGAL NAIL REPAIR PEN	SANSAR, LLC	9c823e27-8bb3-4ccd-bf7e-a99d45908e88	2025-04-25	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER CUCUMBER MELON	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3380404d-9499-e9fb-e063-6394a90a0f27	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER SWEET GUAVA FRESH COCONUT	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3380fe6d-e059-401a-e063-6394a90a787a	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER DRAGONFRUIT JASMINE	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3381cefb-281c-9b85-e063-6294a90acfd9	2025-04-24	Warnings	Exact identifier application number: M005
Wish Hand Sanitizer Coconut Cream White Florals	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	33826aef-6e50-2730-e063-6394a90a727b	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER GOLDEN CITRUS	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3391a78e-525d-c2ba-e063-6394a90a1e99	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER SALTED CARAMEL PISTACHIO	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	33927939-a9dc-ab67-e063-6394a90a71cc	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER BLACK PLUM VANILLA	ALCOHOL HAND SANITIZER	PT. SUPER HOME PRODUCT INDONESIA	336c751f-6a33-ca55-e063-6394a90a9749	2025-04-23	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER VIOLET ORCHID SANDALWOOD	ALCOHOL HAND SANITIZER	PT. SUPER HOME PRODUCT INDONESIA	337e4526-238a-bc2d-e063-6394a90a5a27	2025-04-23	Warnings	Exact identifier application number: M005
ELLEN HAND SANITIZER2	ETHYL ALCOHOL	PT. SUPER HOME PRODUCT INDONESIA	334574b6-6d4a-bd37-e063-6394a90a67d6	2025-04-21	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	GERI-GENTLE CORPORATION	e6734616-c16b-430c-e053-2a95a90a18f8	2025-04-21	Warnings	Exact identifier application number: M005
Clotrimazole 1% Athletes Foot	CLOTRIMAZOLE	GERI-GENTLE CORPORATION	e673748f-d00b-4ce8-e053-2995a90a9220	2025-04-21	Warnings	Exact identifier application number: M005
PHYTOZINE RINGWORM TREATMENT MAXIMUM STRENGTH	TOLNAFTATE	The Sisquoc Healthcare Corporation	5dff6ee7-f7a9-4841-8357-6b0801d253f1	2025-04-21	Warnings	Exact identifier application number: M005

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
998461	miconazole nitrate 2 % Topical Powder	PSN	1651bdd7-ab15-7a2d-e063-6294a90a8b91	4
998461	miconazole nitrate 0.02 MG/MG Topical Powder	SCD	1651bdd7-ab15-7a2d-e063-6294a90a8b91	4
998461	miconazole nitrate 2 % Topical Powder	SY	1651bdd7-ab15-7a2d-e063-6294a90a8b91	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51316-980-01	51316098001	71 g in 1 BOTTLE, PLASTIC (51316-980-01)	71 g	2024-04-17	No	No	Current