Clear Defense

Product NDC: 54473-296
Requested package NDC: 54473-296-09
11-digit product format: 544730296
Labeler code: 54473
Product ID: 54473-296_f205510b-90fb-770f-e053-2995a90a7fb0
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Melaleuca, Inc.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-04-09
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 151 g/266mL
NDC exclude flag: No
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	54473-296	54473-296-09	I	Inactivated by FDA		2026-10-15

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
54473-296-09	2025-01-30	Clear Defense Hand Gel 9oz
54473-296-16	2025-01-30	Clear Defense Hand Gel 9oz
54473-296-18	2025-01-30	Clear Defense Hand Gel 9oz
54473-296-24	2025-01-30	Clear Defense Hand Gel 9oz
54473-296-09	2020-03-19	Clear Defense Hand Gel 9oz
54473-296-09	2020-01-31	Clear Defense Hand Gel 9oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54473-296-09	Clear Defense	266 mL in 1 BOTTLE	GEL	266	6
54473-296-16	Clear Defense	473 mL in 1 BOTTLE	GEL	473	6
54473-296-18	Clear Defense	53 mL in 1 BOTTLE	GEL	53	6
54473-296-24	Clear Defense	71 mL in 1 BOTTLE	GEL	71	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-296	CLEAR DEFENSE (ETHYL ALCOHOL) GEL [MELALEUCA, INC.]	6	Legacy NDC, 4 package rows	20230112_25638ab1-afa2-4de5-af20-cdb0a08a0c50.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54473-296-09	54473029609	266 mL in 1 BOTTLE (54473-296-09)	266 ml	2018-01-01	0000-00-00	No	No	Current