Antifungal Cream

Product NDC: 68788-8645
Requested package NDC: 68788-8645-2
11-digit product format: 687888645
Labeler code: 68788
Product ID: 68788-8645_563c9163-7990-474d-bdf3-427493fd31e2
Type: HUMAN OTC DRUG
Nonproprietary name: antifungal
Dosage form: CREAM
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-05-01
Substance: MICONAZOLE NITRATE
Active strength: 2 g/100g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Antifungal Cream
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	2 g/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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998483	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
c6098653-351a-449f-9b1a-0c617074f2b9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
68788-8645-2	Antifungal Cream	1 in 1 CARTON	CREAM	1		2
68788-8645-2	Antifungal Cream	28.4 g in 1 TUBE	CREAM	28.4		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8645-2	GM - Gram	68788-8645	5a2e575d-4bb1-4f50-abe7-7a058ee9df87	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8645	ANTIFUNGAL CREAM (ANTIFUNGAL) CREAM [PREFERRED PHARMACEUTICALS INC.]	1	Current NDC, 2 package rows	20240531_c6098653-351a-449f-9b1a-0c617074f2b9.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 49 · 974 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LUCKSKY Fungal Nail Renewal	UNDECYLENIC ACID 25% TOLNAFTATE1% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57a73b60-bbac-97e6-e063-6294a90ab9a9	2026-07-28	Warnings	Exact identifier application number: M005
Ponamfo ANTIFUNGAL TREATMENT PEN	UNDECYLENIC	Guangzhou Bixiaoyu Trading Co., Ltd.	57a9ccff-270b-9769-e063-6394a90a5e0c	2026-07-28	Warnings	Exact identifier application number: M005
FUNGAL NAIL PATCHES	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	5240412c-4257-8e9d-e063-6394a90a0a12	2026-07-28	Warnings	Exact identifier application number: M005
FFPMAM Antifungal Cream	FFPMAM ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	57b7cf61-d4cd-53f7-e063-6394a90afc54	2026-07-28	Warnings	Exact identifier application number: M005
Youggle WART REMOVER	SALICYLIC ACID	Guangzhou Huixue Biotechnology Co., Ltd.	57a3744e-316c-8a3d-e063-6294a90a15d1	2026-07-27	Warnings	Exact identifier application number: M005
antifungal pen	ANTIFUNGAL PEN	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	5756256e-ed2b-4e13-e063-6294a90a1e0f	2026-07-24	Warnings	Exact identifier application number: M005
SERYNTH ANTIFUNGAL NAIL TREATMENT PEN	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	4d59116a-bcd0-9ed4-e063-6394a90a6dbd	2026-07-24	Warnings	Exact identifier application number: M005
SERYNTH MULTI-PURPOSE FUNCUS	TOLNAFTATE 1% MULTI-PURPOSE FUNCUS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a6ea0c9-1495-8ede-e063-6294a90ad093	2026-07-23	Warnings	Exact identifier application number: M005
HELPS WITH NAGELPILZ	TOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUID	Shanghai Honghui Chuang Intelligent Technology Co., Ltd	55753a4a-a4d0-a183-e063-6394a90acf11	2026-07-22	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL CARE ESSENTIAL Oil	UNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4ff57d2d-5e74-a995-e063-6394a90a3f9a	2026-07-21	Warnings	Exact identifier application number: M005
WERPEKA FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4f7a8273-b7af-d532-e063-6394a90aa63a	2026-07-21	Warnings	Exact identifier application number: M005
HTRCSW FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% TOENAIL FUNGUS PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	523bc484-511c-b603-e063-6394a90a55ae	2026-07-21	Warnings	Exact identifier application number: M005
DERMFREE Clotrimazole	CLOTRIMAZOLE1% CLOTRIMAZOLE	Jiangxi Yudexi Pharmaceutical Co., LTD	49ab5abb-d311-505d-e063-6294a90a5616	2026-07-21	Warnings	Exact identifier application number: M005
DERMFREE FUNGI NAIL	TOLNAFTATE 1% FUNGI NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	49aba00d-9249-b403-e063-6394a90a787d	2026-07-21	Warnings	Exact identifier application number: M005
SKAPEMED SKIN REPAIR	TOLNAFTATE 1% SKIN REPAIR	Jiangxi Yudexi Pharmaceutical Co., LTD	4a20c32e-0551-aead-e063-6394a90a2aa7	2026-07-21	Warnings	Exact identifier application number: M005
REINREUDE MULTI-PURPOSE TREATMENT	TOLNAFTATE 1% MULTI-PURPOSE TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a380945-9235-783a-e063-6294a90a094d	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH Multi-Purpose Nail Solution	TOLNAFTATE 1% MULTI-PURPOSE NAIL SOLUTION	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4af770-2bba-52a8-e063-6294a90ac287	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH Clotrimazole	CLOTRIMAZOLE1% CLOTRIMAZOLE	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4b304a-1acc-9185-e063-6394a90a1176	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH FUNGI NAIL	TOLNAFTATE 1% FUNGI NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c6b7a-3c3e-1510-e063-6294a90a409a	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH HELPS WITH FUNGAL NAIL	TOLNAFTATE 1% HELPS WITH FUNGAL NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c9ad1-e652-2b3b-e063-6394a90a2935	2026-07-21	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
998483	miconazole nitrate 2 % Topical Cream	PSN	c6098653-351a-449f-9b1a-0c617074f2b9	2
998483	miconazole nitrate 20 MG/ML Topical Cream	SCD	c6098653-351a-449f-9b1a-0c617074f2b9	2
998483	miconazole nitrate 2 % Topical Cream	SY	c6098653-351a-449f-9b1a-0c617074f2b9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8645-2	68788864502	1 TUBE in 1 CARTON (68788-8645-2) / 28.4 g in 1 TUBE	1 tube	2024-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
2% Miconazole Nitrate Cream, USP	Preferred Pharmaceuticals Inc.	2026-07-08	HUMAN OTC DRUG LABEL	3