Vite20

Product NDC: 63347-800
11-digit product format: 633470800
Labeler code: 63347
Product ID: 63347-800_d6d98f0f-58dd-4fb8-9403-5ce47b071e29
Type: HUMAN OTC DRUG
Nonproprietary name: UNDECYLENIC ACID
Dosage form: CREAM
Route: TOPICAL
Labeler: Blaine Labs Inc.
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-02-01
Substance: UNDECYLENIC ACID
Active strength: 2 mg/20mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	63347-800		E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63347-800	63347-800-01	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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: Vite20
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
UNDECYLENIC ACID	2 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K3D86KJ24N	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
18f8ea1c-360e-43c0-98df-5816af4dec66	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63347-800-01	2022-02-21	C162847	48780-1	d6a99b39-37f8-a426-e053-dadaa90af4c2	18f8ea1c-360e-43c0-98df-5816af4dec66
63347-800-01	2022-01-28	C162847	48780-1	d6a99b39-37f8-a426-e053-dadaa90af4c2	18f8ea1c-360e-43c0-98df-5816af4dec66

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63347-800-01	Vite20	20 mL in 1 TUBE	CREAM	20		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
UNDECYLENIC ACID	ACTIVE INGREDIENT	K3D86KJ24N	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
UNDECYLENIC ACID	ACTIVE MOIETY	K3D86KJ24N	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
CLOTRIMAZOLE	INACTIVE INGREDIENT	G07GZ97H65	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
COCO-CAPRYLATE	INACTIVE INGREDIENT	4828G836N6	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)	INACTIVE INGREDIENT	X70SE62ZAR	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
UREA	INACTIVE INGREDIENT	8W8T17847W	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63347-800	VITE20 (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]	5	Current NDC, Legacy NDC, 1 package rows	20241226_18f8ea1c-360e-43c0-98df-5816af4dec66.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 11 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Chain Drug Marketing Association	327095bd-a7c9-291d-e063-6394a90afafa	2026-06-09	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	Chain Drug Marketing Association	34b5c11f-710f-60e4-e063-6394a90a990d	2026-06-09	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE POWDER SPRAY	Chain Drug Marketing Association	342affe8-0a4d-6fe6-e063-6394a90a8dad	2026-06-09	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Chain Drug Marketing Association	edc2da26-ae46-4175-86ed-83e1a65f6d14	2026-06-09	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	Chain Drug Marketing Association	aa97d2ca-bcf4-3ee1-e053-2a95a90a748d	2026-06-09	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE POWDER SPRAY	Chain Drug Marketing Association	1bd8e096-1717-4656-b52c-086d2f56f070	2026-06-09	Warnings	Exact identifier application number: M005
BODYKOO JOCK ITCH Cream	CLOTRIMAZOLE1% JOCK ITCH CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	53553b31-81bb-d293-e063-6294a90aa0a5	2026-06-09	Warnings	Exact identifier application number: M005
BODYKOO ATHLETE FOOT Cream	MICONAZOLE NITRATE2% ATHLETE FOOT CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	53561903-54fe-f8ec-e063-6294a90a19fe	2026-06-09	Warnings	Exact identifier application number: M005
Clotrimazole Cream	CLOTRIMAZOLE USP1%	Aldermed Inc.	53bdd76b-6290-f1d3-e063-6394a90a9ff1	2026-06-08	Warnings	Exact identifier application number: M005
Miconazole Cream	MICONAZOLE NITRATE	Aldermed Inc.	4a7fc48a-c103-dc84-e063-6394a90ab80f	2026-06-08	Warnings	Exact identifier application number: M005
Antifungal Powder	MICONAZOLE NITRATE	Aldermed Inc.	60954089-5220-4f4c-8595-b5ee4562562c	2026-06-08	Warnings	Exact identifier application number: M005
Jock Itch Powder	MICONAZOLE NITRATE	Walgreens Company	06d2f36c-8615-af08-e063-6394a90aa424	2026-06-05	Warnings	Exact identifier application number: M005
Miconazole Nitrate 2%	JOCK ITCH SPRAY	Walgreens Company	cf6cbaf4-beba-6fdf-e053-2995a90a76d2	2026-06-04	Warnings	Exact identifier application number: M005
Charmpoo Antifungal Cream	MICONAZOLE NITRATE 2% ANTIFUNGAL CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	5368b131-7537-8679-e063-6394a90a6754	2026-06-04	Warnings	Exact identifier application number: M005
Nail Fungus Treatment Pen	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	3fe842e1-b3db-c003-e063-6394a90a46b8	2026-06-04	Warnings	Exact identifier application number: M005
Lasolex AC	MICONAZOLE NITRATE 2% ANTIFUNGAL	PureTek Corporation	52bb4bc1-e88f-f5ea-e063-6394a90ae1e8	2026-06-03	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	13a14d3c-bfce-42b5-8463-4ec69e94774e	2026-06-03	Warnings	Exact identifier application number: M005
Kopa Haiku Antifungal Cream	MICONAZOLE NITRATE 2%	Trovina Co. Ltd	43cbad59-9899-ab3b-e063-6294a90a9e12	2026-06-02	Warnings	Exact identifier application number: M005
Athletes Foot Cream	CLOTRIMAZOLE	Shenzhen Miandou Technology Co.,Ltd.	53451e74-719e-9499-e063-6394a90a9e5a	2026-06-02	Warnings	Exact identifier application number: M005
Lasolex AL	MICONAZOLE NITRATE 2% ANTIFUNGAL	PureTek Corporation	534df9be-b47a-03a1-e063-6394a90a265a	2026-06-02	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K3D86KJ24N	UNDECYLENIC ACID	112-38-9	UNDECYLENIC ACID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63347-800-01	63347080001	20 mL in 1 TUBE (63347-800-01)	20 ml	2012-02-01	0000-00-00	No	No	Current