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 3 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a4ac18e-8ba5-bef6-e063-6394a90a8811	2026-08-31	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a4d11fa-3f65-b41f-e063-6394a90a30ae	2026-08-31	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,2pk -Gingerbread and Cherry Cobbler	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a52731b-5e8c-5ae6-e063-6394a90a8b04	2026-08-31	Warnings	Exact identifier application number: M003
70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	UpLift Brands, LLC	8ae12375-3a95-475c-9600-17c51a9103f7	2026-08-31	Warnings, Adverse reactions	Exact identifier application number: M003
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggets	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	f875e065-7b3e-45dc-8a33-b893ab830695	2026-08-31	Warnings	Exact identifier application number: M003
hydrating mist hand sanitizer with silicone keychain holder - signature scent	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	30e11bf0-1a21-45b1-adf9-cf3845419a98	2026-08-31	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer(Oval Shape)with Beaded Wristlet - Cherry Blossom	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a4fb4b6-ba9e-5b82-e063-6294a90a4734	2026-08-30	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer with Woven Lanyard and Chainendants- Watermelon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a503581-061b-0050-e063-6294a90af48a	2026-08-30	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,2pk-Christmas Rose and Candy Cane	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a50402b-e4d7-3c0b-e063-6394a90a5e52	2026-08-30	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,2pk -Bourbon Peacan and Mistletoe	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a508fad-c7a4-82e8-e063-6294a90a0de1	2026-08-30	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer with Beaded Wristlet - Espresso	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	59f160d3-7e42-ef07-e063-6394a90a6f8f	2026-08-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,4pk with Silicone Case,Cherry Blossom /Gardenia /Lavender Vanilla/ Coconut Honey	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a2ab646-2dba-5111-e063-6394a90acc4f	2026-08-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Strawberry Dream/ Berry Bliss	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a2b50a2-6ee2-04d4-e063-6294a90a1c65	2026-08-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Cherry and Honey Vanilla	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a2c11e6-a105-5362-e063-6394a90a132f	2026-08-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case,2pk Vanilla Chai and Espresso	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	59ef14d6-1a40-ea3c-e063-6394a90af442	2026-08-28	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case , 2pk Champagne Toast and Sparkling Pomegranate	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	597530cb-03f6-b72d-e063-6394a90a0d6c	2026-08-28	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,4pk with Silicone Case,Rosewater/Raspberry Fizz/Strawberry Vanilla/Pink Peony	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	59f1521c-ad5c-e2d6-e063-6394a90a4e2b	2026-08-28	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Sparkling Watermelon/ Pomegranate Raspberry	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a2a89f4-838e-e3ea-e063-6294a90a1ac2	2026-08-27	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	59ed87d5-dab1-abab-e063-6394a90a024d	2026-08-26	Warnings	Exact identifier application number: M003
Povidone Iodine Swabstick	POVIDONE IODINE 10%	Trifecta Pharmaceuticals USA LLC	59f82f9d-8c39-6890-e063-6294a90a090e	2026-08-26	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