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 87 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand sanitizer 16.9oz with vitamin E	ETHYL ALCOHOL 70%	REJOICE INTERNATIONAL CORP.	03f869b3-3004-8b25-e063-6294a90a176e	2025-02-06	Warnings	Exact identifier application number: M003
Isopropyl alcohol 70 percent Wintergreen	ISOPROPYL ALCOHOL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	444cd7f4-cf61-49b6-a93e-915d250838da	2025-02-06	Warnings	Exact identifier application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON VANILLIA	ALCOHOL ANTISEPTIC GEL	Kingkey MBC Life Technology Group Co.,Ltd	2d613ab9-c87b-1f3c-e063-6394a90a3120	2025-02-05	Warnings	Exact identifier application number: M003
ORBIT INNOVATIONS HAND SANITIZER COCONUT	ALCOHOL ANTISEPTIC GEL	Kingkey MBC Life Technology Group Co.,Ltd	2d6148e2-d959-6150-e063-6294a90acba5	2025-02-05	Warnings	Exact identifier application number: M003
ORBIT INNOVATIONS HAND SANITIZER WATERMELON	ALCOHOL ANTISEPTIC GEL	Kingkey MBC Life Technology Group Co.,Ltd	2d6175c9-abe5-4c68-e063-6394a90afc36	2025-02-05	Warnings	Exact identifier application number: M003
Hand sanitizer 29ml 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	eb5d6739-ee36-cd74-e053-2a95a90ab659	2025-02-05	Warnings	Exact identifier application number: M003
Hand sanitizer 29ml 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	037b4acb-49ca-bc0a-e063-6394a90a1fcc	2025-02-05	Warnings	Exact identifier application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPES	BENZALKONIUM CHLORIDE	Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.	ecef31dc-2f36-b578-e053-2995a90a3acd	2025-02-05	Warnings	Exact identifier application number: M003
Isopropyl alcohol 91 percent	ISOPROPYL ALCOHOL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	444883fc-7ae4-4dd3-bd2b-f94c3265c170	2025-02-05	Warnings	Exact identifier application number: M003
PHARMACIST CHOICE ALCOHOL STERILE PREP PAD	ISOPROPYL ALCOHOL	Simple Diagnostics	0fc4a4b2-342b-5948-e054-00144ff88e88	2025-02-04	Warnings	Exact identifier application number: M003
HAND SANITIZER VANILLA	ALCOHOL ANTISEPTIC GEL	Kingkey MBC Life Technology Group Co.,Ltd	32055326-c229-5f10-e063-6394a90ab62c	2025-02-01	Warnings	Exact identifier application number: M003
Hand Sanitizer Pink Sugar	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	322e5a64-dda1-c24e-e063-6394a90a8298	2025-02-01	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Jianerkang Medical Co., Ltd	3fce67c9-14e9-4e26-bb7f-9375a7f84a8a	2025-01-31	Warnings	Exact identifier application number: M003
Antiseptic	ALCOHOL	Welly Health PCB	85ce2c23-25d8-4b35-95ff-99f098d92bc9	2025-01-29	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International Corp.	4e13511b-fbb3-2523-e054-00144ff88e88	2025-01-28	Warnings	Exact identifier application number: M003
Hand Sanitizer 1.8 oz Strawberry Scented	ETHYL ALCOHOL	Ningbo Rejoice International	a267a7a2-79b9-1da3-e053-2995a90a3a11	2025-01-28	Warnings	Exact identifier application number: M003
On Guard Sanitizing Gel	ALCOHOL	doTERRA International, LLC	e4b8b4bb-1d47-6826-e053-2a95a90ab168	2025-01-28	Warnings	Exact identifier application number: M003
germstarLuxe	ETHYL ALCOHOL	Soaptronic, LLC	471b466f-e3e5-3601-e054-00144ff88e88	2025-01-28	Warnings	Exact identifier application number: M003
Refill 4	ISOPROPYL ALCOHOL	GFA Production (Xiamen) Co., Ltd.	51348666-53e3-4cc7-99ba-cf3f23ddbcf6	2025-01-27	Warnings	Exact identifier application number: M003
Refill 3	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	GFA Production (Xiamen) Co., Ltd.	0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa	2025-01-27	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