Sanitex Antibacterial Hand Wipes

Product NDC: 53118-002
11-digit product format: 531180002
Labeler code: 53118
Product ID: 53118-002_453a544a-99f3-bcdc-e063-6394a90ab429
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: SWAB
Route: TOPICAL
Labeler: Precare Corp
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-06-17
Substance: BENZALKONIUM CHLORIDE
Active strength: .13 g/100g
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 · 3 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	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	53118-002		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53118-002	53118-002-02	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53118-002	53118-002-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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: Sanitex Antibacterial Hand Wipes
Brand name suffix: Fresh Scent
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	.13 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1038558	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
48907146-ca66-46e1-928b-a8f968a6bff8	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53118-002-01	2020-07-08	Drug Facts
53118-002-02	2020-07-08	Drug Facts
53118-002-01	2020-01-31	Drug Facts
53118-002-02	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53118-002-01	Sanitex Antibacterial Hand WipesFresh Scent	3 g in 1 PACKAGE	SWAB	3	8
53118-002-01	Sanitex Antibacterial Hand WipesFresh Scent	40 in 1 CANISTER	SWAB	40	8
53118-002-02	Sanitex Antibacterial Hand WipesFresh Scent	3 g in 1 POUCH	SWAB	3	8
53118-002-02	Sanitex Antibacterial Hand WipesFresh Scent	20 in 1 BAG	SWAB	20	8
53118-002-03	Sanitex Antibacterial Hand WipesFresh Scent	1 in 1 PACKAGE	SWAB	1	8
53118-002-03	Sanitex Antibacterial Hand WipesFresh Scent	3 g in 1 PACKAGE	SWAB	3	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]	1
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]	1
DECYL GLUCOSIDE	INACTIVE INGREDIENT	Z17H97EA6Y	SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53118-002	SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PRECARE CORP]	7	Current NDC, Legacy NDC, 6 package rows	20241211_48907146-ca66-46e1-928b-a8f968a6bff8.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 81 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Unguentine	PHENOL, ZINC OXIDE	Oakhurst Company	327038a1-b825-1199-e063-6394a90a7f5f	2025-04-10	Warnings	Exact identifier application number: M003
Northside Hospital Grey Amenity Kit	SODIUM MONOFLUOROPHOSPATE	ASP Global, LLC	a3cc89df-be1b-4d9a-8ba3-857885325422	2025-04-09	Warnings	Exact identifier application number: M003
Isopropyl alcohol 70 percent	ISOPROPYL ALCOHOL	TOP CARE (Topco Associates LLC)	afe23634-27a4-46cf-b428-8fa3a274712c	2025-04-09	Warnings	Exact identifier application number: M003
Isopropyl Alcohol 91 percent	ISOPROPYL ALCOHOL	TOP CARE (Topco Associates LLC)	3c70ba1c-b12f-4a98-b993-1179ebe3e070	2025-04-09	Warnings	Exact identifier application number: M003
Band Aid Antiseptic Cleansing	BENZALKONIUM CHLORIDE	Kenvue Brands LLC	d3190050-d646-5957-e053-2995a90ad521	2025-04-08	Warnings	Exact identifier application number: M003
mart Care Assorted Hand Sanitizer 0.94oz-Sweet Pea 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	322b90e8-be38-7237-e063-6394a90a488f	2025-04-07	Warnings	Exact identifier application number: M003
Meijer Hydrating Hand Sanitizer 1oz - Watermelon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	322c0bdd-4dc5-52e7-e063-6294a90a1380	2025-04-07	Warnings	Exact identifier application number: M003
Meijer Hydrating Hand Sanitizer 1oz - Berry	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	322c56b0-7eb6-c33a-e063-6394a90a15fb	2025-04-07	Warnings	Exact identifier application number: M003
Meijer Hydrating Hand Sanitizer 1oz - Vanilla	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	322ce179-c528-0f62-e063-6394a90ac560	2025-04-07	Warnings	Exact identifier application number: M003
MEDI-FIRST First Aid Antiseptic	HYDROGEN PEROXIDE	Ultra Distributors Inc	b6f7b346-3d6b-5953-e053-2995a90a878f	2025-04-07	Warnings	Exact identifier application number: M003
MEDI-FIRST First Aid Antiseptic	ISOPROPYL ALCOHOL	Ultra Distributors Inc	b6c88941-9982-3a37-e053-2995a90a8a5a	2025-04-07	Warnings	Exact identifier application number: M003
Walgreens Max Strength Burn Gel	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Walgreens Co.	25a1e89b-bafd-4770-e063-6294a90a14d2	2025-04-07	Warnings	Exact identifier application number: M003
Eye Wash	WATER	CMC Group Inc.	6158a1f5-a6bc-4a3e-9d1d-0a310d9dc561	2025-04-02	Warnings	Exact identifier application number: M003
Standard ANSI First Aid	WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE	CMC Group, Inc.	e1ef74bf-8895-4200-a411-f726dcdaa945	2025-04-02	Warnings	Exact identifier application number: M003
Clear Defense	ETHYL ALCOHOL	Melaleuca, Inc.	a2178a68-780e-e69b-e053-2a95a90ab7d6	2025-04-02	Warnings	Exact identifier application number: M003
Large ANSI First Aid Kit	WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE	CMC Group, Inc.	fa8578c2-a0bc-4e2e-a4f9-d48debfff378	2025-04-02	Warnings	Exact identifier application number: M003
ETHYL ALCOHOL	ALCOHOL	ASP Global LLC	67a4b949-ce8a-4841-a965-fcc94165135c	2025-04-02	Warnings	Exact identifier application number: M003
Sanitizing Hand Mist	ETHYL ALCOHOL	ALO New York LLC	31baefe1-2521-9ef3-e063-6294a90a450e	2025-04-01	Warnings	Exact identifier application number: M003
Deconimo	HAND SANITIZING WIPES	IMAGINE AMAZON LLC	311c670d-8f87-b746-e063-6294a90afd5e	2025-04-01	Warnings	Exact identifier application number: M003
Meijer Antibacterial Foaming Hand Wash	0.13% BENZALKONIUM CHLORIDE SOLUTION	Meijer, Inc.	1eb6b603-ef96-dfda-e063-6294a90ae468	2025-03-31	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038558	benzalkonium chloride 0.13 % Medicated Pad	PSN	48907146-ca66-46e1-928b-a8f968a6bff8	8
1038558	benzalkonium chloride 1.3 MG/ML Medicated Pad	SCD	48907146-ca66-46e1-928b-a8f968a6bff8	8
1038558	benzalkonium chloride 0.13 % Topical Cloth	SY	48907146-ca66-46e1-928b-a8f968a6bff8	8
1038558	benzalkonium chloride 0.13 % Topical Swab	SY	48907146-ca66-46e1-928b-a8f968a6bff8	8
1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Pad	SY	48907146-ca66-46e1-928b-a8f968a6bff8	8
1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Swab	SY	48907146-ca66-46e1-928b-a8f968a6bff8	8
1038558	benzalkonium chloride 1 ML per 750 ML Topical Swab	SY	48907146-ca66-46e1-928b-a8f968a6bff8	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53118-002-01	53118000201	40 PACKAGE in 1 CANISTER (53118-002-01) / 3 g in 1 PACKAGE	40 package	2015-06-17	0000-00-00	No	No	Current
53118-002-02	53118000202	20 POUCH in 1 BAG (53118-002-02) / 3 g in 1 POUCH	20 pouch	2015-06-17	0000-00-00	No	No	Current
53118-002-03	53118000203	1 PACKAGE in 1 PACKAGE (53118-002-03) / 3 g in 1 PACKAGE	1 package	2020-07-10	0000-00-00	No	No	Current