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 2 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walmart	ISOPROPYL ALCOHOL	Walmart, Inc.	2eff98ba-5736-b07e-e063-6394a90aeea9	2026-09-04	Warnings	Exact identifier application number: M003
Walgreen Alcohol	ISOPROPYL ALCOHOL	Walgreens Company	deeae1ea-3d81-4260-95be-c4f328e3fdef	2026-09-04	Warnings	Exact identifier application number: M003
Dollar General	ISOPROPYL ALCOHOL	Dollar General Corporation	00b2ef34-42d9-523c-e063-6294a90a753d	2026-09-03	Warnings	Exact identifier application number: M003
Signature Select Alcohol Prep Pads	ISOPROPYL ALCOHOL	Better Living Brands LLC	31ce72e3-03a3-1608-e063-6394a90ad850	2026-09-03	Warnings	Exact identifier application number: M003
SurviveX Sting Relief	STING RELIEF WIPE	Changzhou Maokang Medical Products Co., Ltd.	5a83b1f1-c8dc-cf07-e063-6394a90a20ca	2026-09-03	Warnings	Exact identifier application number: M003
Benzethonium chloride Plus Dyclonine hydrochloride	LIQUID BANDAGE	Kroger Co.	fe604470-917f-4cbd-a1e6-ac1dc7c57ff6	2026-09-02	Warnings	Exact identifier application number: M003
Alcohol	ISOPROPYL ALCOHOL	Rite Aid Corporation	5104f9ab-0b28-449f-a55a-5438713a24df	2026-09-02	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	UpLift Brands, LLC	5a81b635-d188-0b29-e063-6294a90a1e4b	2026-09-02	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	CVS Pharmacy, Inc.	7f518646-c8fe-499a-b5e4-8e5a5a90e01d	2026-09-02	Warnings, Adverse reactions	Exact identifier application number: M003
Alcohol	ISOPROPYL ALCOHOL	The Kroger Company	6551187f-5cde-4149-931f-b057bd760750	2026-09-02	Warnings	Exact identifier application number: M003
Unscented NasalGuard Antiseptic Topical	BENZALKONIUM CHLORIDE	TRUTEK CORP.	eb036e11-a28c-fdc0-e053-2a95a90a9cdb	2026-09-02	Warnings	Exact identifier application number: M003
Harris Teeter	ISOPROPYL ALCOHOL	Harris Teeter, LLC	d2bb20bd-ec83-8d80-e053-2a95a90a2bba	2026-09-02	Warnings	Exact identifier application number: M003
School Health	ISOPROPYL ALCOHOL	School Health Corporation	db5d0b22-f2d7-23e5-e053-2a95a90aeb51	2026-09-02	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Topco Associates	2642298f-607e-fdca-e063-6394a90a69d9	2026-09-02	Warnings	Exact identifier application number: M003
HUSTLE BUTTER NUMBING	LIDOCAINE HCL, BENZALKONIUM CHLORIDE	H.B.D. DIST. INC.	5b4d0390-dac6-4a71-9fdc-5c31543e7c5a	2026-09-02	Warnings	Exact identifier application number: M003
NasalGuard Antiseptic Topical Cool Menthol	BENZALKONIUM CHLORIDE	TRUTEK CORP.	e9fd3ef8-78ff-6c9f-e053-2a95a90a21a8	2026-09-01	Warnings	Exact identifier application number: M003
Maximum Strength Betadine Clear	BENZALKONIUM CL AND PRAMOXINE HCL	Atlantis Consumer Healthcare, Inc.	31b94a76-1536-47c0-ab03-e487c2625c58	2026-08-31	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a28101f-ea8e-6071-e063-6294a90aad91	2026-08-31	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a3e62ce-52dc-121b-e063-6294a90a898f	2026-08-31	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a49db18-c270-6f46-e063-6294a90afb5d	2026-08-31	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