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 49 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Evercare Antifungal Treatment Super Absorbent Powder	MICONAZOLE NITRATE	PANEFFORT, LLC	f91910f3-b461-43a4-9120-fda69483fffa	2023-10-26	Warnings	Exact identifier application number: M005
Thera plus Antifungal Clotrimazole	CLOTRIMAZOLE	FOURSTAR GROUP USA, INC.	1265be99-8922-4b76-bd63-19bfb42c3896	2023-10-26	Warnings	Exact identifier application number: M005
Thera plus Antifungal Tolnaftate	TOLNAFTATE	FOURSTAR GROUP USA, INC.	c628dda8-7a6d-5f3a-e053-2995a90a35f8	2023-10-26	Warnings	Exact identifier application number: M005
Povidone Iodine	POVIDONE IODINE	Jianerkang Medical Co., Ltd	e1789944-3a41-4c86-b173-3a6993ae2141	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Impregnated	POVIDONE IODINE	Jianerkang Medical Co., Ltd	14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Impregnated	POVIDONE IODINE	Jianerkang Medical Co., Ltd	b82cea56-b09f-411d-a6cf-c53b3ce0e3b6	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Scrub	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	78131b57-1ffc-4eb8-821e-f7bb73300fe9	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine	POVIDONE IODINE	Jianerkang Medical Co., Ltd	eb30e5de-9074-4760-8e92-e1d1c127227d	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine	POVIDONE IODINE	Jianerkang Medical Co., Ltd	0bd3de76-b726-41f1-87bc-14ab8a1eca8e	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Prep Pad	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	be85ec5b-eb49-4f1a-a87d-5c9705a20f23	2023-10-22	Warnings	Exact identifier application number: M005
EVERLIT CARE Hand Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	579c1ab5-50b4-4b5a-a189-c1e2827d0c3a	2023-10-14	Warnings	Exact identifier application number: M005
Micomitin Antifungal	CLOTRIMAZOLE	PureTek Corporation	dd05f5f9-2412-1295-e053-2995a90acb96	2022-02-14	Warnings	Exact identifier application number: M005
Micatin	MICONAZOLE NITRATE	WellSpring Pharmaceutical Corporation	96c56ba1-c3a8-48ce-ab58-550959485e3c	2016-04-07	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