Home NDC 53118-002 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 Reporting period 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 Uploaded 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 105 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Novex Hand Sanitizer BENZALKONIUM CHLORIDE Natural Essentials, Inc. 8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3 2024-03-20 Warnings Exact identifier application number: M003 Antiseptic BENZALKONIUM CHLORIDE 0.13% Trifecta Pharmaceuticals USA, LLC. 13f1c70f-3b44-8eef-e063-6294a90af634 2024-03-18 Warnings Exact identifier application number: M003 Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HCI Trifecta Pharmaceuticals USA LLC 1308ce91-2858-310a-e063-6394a90a6810 2024-03-06 Warnings Exact identifier application number: M003 Instant Hand Sanitizer - Cocoa Butter ETHYL ALCOHOL Rejoice International, Inc. 97dee45e-53be-4b37-a427-fc24388c0e05 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer Aloe Vera ETHYL ALCOHOL Rejoice International, Inc. 1e28454c-f5d8-4d6e-91f9-bc4501b027c1 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer - Clear ETHYL ALCOHOL Rejoice International, Inc. f0e637d9-d61e-466d-9e05-f906639dbaca 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International, Inc. 07b163e4-8f67-44e7-b5ef-f237023080e0 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer - Ice Clear ETHYL ALCOHOL Rejoice International, Inc. 605ec88a-2f4c-4716-8522-eb2748b43398 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer - Original ETHYL ALCOHOL Rejoice International, Inc. bb9cc886-275e-4996-99dc-529f928b4905 2024-02-28 Warnings Exact identifier application number: M003 Liquid Hand Cleanse TRICLOSAN Rejoice International, Inc. 23ff5450-8308-41c0-9052-1ac4c4433d6c 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Antibacterial Hand Cleanse Original TRICLOSAN Rejoice International, Inc. b5ce6663-fe82-4da1-923e-acea293d7a00 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate TRICLOSAN Rejoice International, Inc. b68a7d64-2650-4fc6-a89e-05de9098a2a3 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Antibacterial Hand Cleanse Mountain Spring TRICLOSAN Rejoice International, Inc. c31723d5-a313-448a-8b69-ca5f8dec25ed 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom BENZALKONIUM CHLORIDE Rejoice International a9a1467c-abcc-4ccb-88f6-430279609788 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom BENZALKONIUM CHLORIDE Rejoice International 9fa9d955-7167-4a0a-935b-2a600f439eb0 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower BENZALKONIUM CHLORIDE Rejoice International 157a14bf-f46e-49f8-96f4-a6c472eb5cb8 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foaming Hand Sanitizer BENZALKONIUM CHLORIDE Rejoice International 3082cbbb-a0ed-45eb-a116-ad1c65357dd1 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast BENZALKONIUM CHLORIDE Rejoice International 45b3ca49-edb4-4840-b857-d24045494a3a 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower BENZALKONIUM CHLORIDE Rejoice International 4890f81e-7994-4ea2-9412-5614c405a2a3 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Wild Berry Blast BENZALKONIUM CHLORIDE Rejoice International 5c109f7c-1f4d-484a-b6ea-3bbcf572bbac 2024-02-28 Warnings Exact identifier application number: M003
DailyMed RxNorm Mappings# 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