Clear Defense

Product NDC: 54473-311
11-digit product format: 544730311
Labeler code: 54473
Product ID: 54473-311_31ce46cd-0dc8-8d08-e063-6294a90af45a
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Melaleuca, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-03-31
Substance: ALCOHOL
Active strength: 150.97 g/266mL
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 · 35 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54473-311-24	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54473-311-09	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54473-311-18	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54473-311-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54473-311-24	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54473-311-09	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54473-311-18	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54473-311-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54473-311-24	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54473-311-09	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54473-311-18	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54473-311-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54473-311-24	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54473-311-09	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54473-311-18	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54473-311-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54473-311-18	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54473-311-16	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54473-311-24	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54473-311-09	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-311-18	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-311-16	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-311-24	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-311-09	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-311-18	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-311-16	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-311-24	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-311-09	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Clear Defense
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	150.97 g/266mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	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
a2178a68-780e-e69b-e053-2a95a90ab7d6	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
54473-311-09	2025-04-07	Clear Defense Hand Gel
54473-311-16	2025-04-07	Clear Defense Hand Gel
54473-311-18	2025-04-07	Clear Defense Hand Gel
54473-311-24	2025-04-07	Clear Defense Hand Gel
54473-311-09	2025-01-30	Clear Defense Hand Gel
54473-311-16	2025-01-30	Clear Defense Hand Gel
54473-311-18	2025-01-30	Clear Defense Hand Gel
54473-311-24	2025-01-30	Clear Defense Hand Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54473-311-09	Clear Defense	266 mL in 1 BOTTLE	GEL	266	3
54473-311-16	Clear Defense	473 mL in 1 BOTTLE	GEL	473	3
54473-311-18	Clear Defense	53 mL in 1 BOTTLE	GEL	53	3
54473-311-24	Clear Defense	71 mL in 1 BOTTLE	GEL	71	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-311	CLEAR DEFENSE (ETHYL ALCOHOL) GEL [MELALEUCA, INC.]	3	Current NDC, Legacy NDC, 4 package rows	20250409_a2178a68-780e-e69b-e053-2a95a90ab7d6.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 6 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CharmTex Lightly Scented Antibacterial	BENZETHONIUM CHLORIDE	Yangzhou Jyr daily chemical Co., Ltd	4b642dfa-f044-4410-81e4-142f0497f0f3	2026-08-06	Warnings	Exact identifier application number: M003
antibacterial wipes 01	BENZALKONIUM CHLORIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	585dec39-ccb8-d2ba-e063-6394a90aec0f	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer PASSION MANGO SPLASH	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585df6ce-4625-d5d2-e063-6394a90a7fcb	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer LILY SPRINGS	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585e0c24-7f5f-4ba7-e063-6294a90a7597	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer WATERMELON POP	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585e3ced-fa45-8576-e063-6294a90af50f	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer ALOE BREEZE	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585e647c-2904-2d3f-e063-6394a90a2b79	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer LAVENDER DREAM	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585e8222-fad5-4409-e063-6394a90a9c60	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer JUICY APPLE	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585eb222-5495-65ed-e063-6394a90a7cfa	2026-08-06	Warnings	Exact identifier application number: M003
Hydrating Hand Sanitizer PEACH GLOW	ALCOHOL 75%	Guangzhou Ailizhuangsi Cosmetics Co., Ltd.	585ed56e-362e-7c50-e063-6394a90a1932	2026-08-06	Warnings	Exact identifier application number: M003
Isopropyl alcohol 70 percent ReadyInCase	ISOPROPYL ALCOHOL	P & L Development, LLC	57c496b3-10ab-4a72-8d8f-42a2256189dd	2026-08-06	Warnings	Exact identifier application number: M003
PROHEAL ALCOHOL PREP PADS	ISOPROPYL ALCOHOL	Click Industries LLC	d272c1f6-e9c9-4099-9d24-f5aae44082ae	2026-08-05	Warnings	Exact identifier application number: M003
Wish Sanitizing Hand Wipes	BENZALKONIUM CHLORIDE	Zhejiang Bright Care Co., Ltd.	c81c0924-bb01-4fa2-b933-8777358e45e7	2026-08-05	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer JAPANESE CHERRY BLOSSOM	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5833c261-021a-2db2-e063-6394a90a22b0	2026-08-04	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer Soft Petals	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	583438a6-c06c-87f5-e063-6394a90adec1	2026-08-04	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer Hibiscus and Aloe	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5834801e-20e5-bffb-e063-6394a90a0359	2026-08-04	Warnings	Exact identifier application number: M003
Medi-First Antiseptic Wipes	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	d31fe110-6d75-bf15-e053-2a95a90a8694	2026-08-03	Warnings	Exact identifier application number: M003
First Shield	HYDROGEN PEROXIDE	EVER READY FIRST AID	94307d2f-5366-4fdb-b919-4a8658dda058	2026-08-03	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer Passion Fruit Splash	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	583159a9-331a-b53b-e063-6294a90a41a3	2026-08-03	Warnings	Exact identifier application number: M003
BBlove Hand Sanitizer Fresh Squeezed Spearmint	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	581b4b8d-fe65-f297-e063-6394a90a5a43	2026-08-02	Warnings	Exact identifier application number: M003
Mistify Hand Sanitizer Cotton Candy and Gummy Bear	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5987e492-b3b6-ed57-e063-6394a90a223a	2026-08-01	Warnings	Exact identifier application number: M003

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
54473-311-09	54473031109	266 mL in 1 BOTTLE (54473-311-09)	266 ml	2020-03-31	0000-00-00	No	No	Current
54473-311-16	54473031116	473 mL in 1 BOTTLE (54473-311-16)	473 ml	2020-03-31	0000-00-00	No	No	Current
54473-311-18	54473031118	53 mL in 1 BOTTLE (54473-311-18)	53 ml	2020-03-31	0000-00-00	No	No	Current
54473-311-24	54473031124	71 mL in 1 BOTTLE (54473-311-24)	71 ml	2020-03-31	0000-00-00	No	No	Current