Benzalkonium Chloride

Product NDC
82355-550
11-digit product format
823550550
Labeler code
82355
Product ID
82355-550_48751555-8dc5-33e6-e063-6394a90aec65
Type
HUMAN OTC DRUG
Nonproprietary name
Sanitizing Hand Wipes
Dosage form
CLOTH
Route
TOPICAL
Labeler
ALO NEW YORK LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-21
Substance
BENZALKONIUM CHLORIDE
Active strength
.0013 mg/100mg
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Benzalkonium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.0013 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d3afde78-b9f6-3648-e053-2a95a90a4024Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82355-550-01Benzalkonium Chloride1 mg in 1 PACKAGECLOTH16
82355-550-01Benzalkonium Chloride20 in 1 PACKAGECLOTH206
82355-550-02Benzalkonium Chloride1 mg in 1 PACKAGECLOTH16
82355-550-02Benzalkonium Chloride20 in 1 PACKAGECLOTH206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82355-550BENZALKONIUM CHLORIDE (SANITIZING HAND WIPES) CLOTH [ALO NEW YORK LLC]4Current NDC, Legacy NDC, 4 package rows20241218_d3afde78-b9f6-3648-e053-2a95a90a4024.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 92 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
germstarCitrusETHYL ALCOHOLSoaptronic, LLC779abef7-53ff-47c3-b7e6-27570eb055b32024-12-19WarningsExact identifier
application number: M003
germstarGelETHYL ALCOHOLSoaptronic, LLCb5fd6c3c-d452-74e6-e053-2995a90a90902024-12-19WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd98812b-017a-2cd2-e053-2a95a90a38ce2024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLMY IMPORTS LLCd4d72406-067d-1f67-e053-2995a90a1a9f2024-12-18WarningsExact identifier
application number: M003
AMORAY 70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORT USA INC7114b527-106b-4629-867c-63dba13635a22024-12-18WarningsExact identifier
application number: M003
AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7e7f8-7c8a-2b51-e053-2995a90a63d02024-12-18WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLMy Imports USA, LLCd4d77ec3-4930-74f0-e053-2a95a90a962a2024-12-18WarningsExact identifier
application number: M003
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7adaf-c0fd-82fa-e053-2995a90ab9f62024-12-18WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA, LLCde47bf08-f64e-781d-e053-2a95a90ab08f2024-12-18WarningsExact identifier
application number: M003
AMERICAN REDCROSS 91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d80ae4-3fba-4605-e053-2a95a90a21192024-12-18WarningsExact identifier
application number: M003
American Red Cross 50% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMY IMPORTS USA LLCde47a879-9cd0-5fbb-e053-2a95a90a1fba2024-12-18WarningsExact identifier
application number: M003
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5ee961-1d64-0d9d-e053-2a95a90a60102024-12-18WarningsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLSZY Holdings, LLC dba EverReady First Aid1e39b0f4-66d1-47ac-aed6-d6ac019888ce2024-12-18WarningsExact identifier
application number: M003
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5eb0df-cd2d-691c-e053-2995a90a25112024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLFirst Aid Research Corp.7d1c0382-31b3-48d0-a514-c5cc45a2299e2024-12-18WarningsExact identifier
application number: M003
First Aid Only First Aid-BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEAcme United Corporationf31a44ff-e4ac-de1e-e053-2a95a90ab0362024-12-18WarningsExact identifier
application number: M003
Hand Sanitizer (Lavender Rosemary)HAND SANITIZER SPRAYTubby Todd2992a52a-21a9-18be-e063-6294a90a834d2024-12-18WarningsExact identifier
application number: M003
CVS Decolorized IodineALCOHOLCVS Pharmacyd9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd2024-12-18WarningsExact identifier
application number: M003
De La Cruz Decolorized IodineETHYL ALCOHOLDLC Laboratories, Inc.5d8f6aaa-0b87-1166-e053-2991aa0a297f2024-12-18WarningsExact identifier
application number: M003
Humco Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.1e078022-f32c-48bd-8add-f83aebcc58122024-12-18WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNd3afde78-b9f6-3648-e053-2a95a90a40246
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDd3afde78-b9f6-3648-e053-2a95a90a40246
1038558benzalkonium chloride 0.13 % Topical ClothSYd3afde78-b9f6-3648-e053-2a95a90a40246
1038558benzalkonium chloride 0.13 % Topical SwabSYd3afde78-b9f6-3648-e053-2a95a90a40246
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYd3afde78-b9f6-3648-e053-2a95a90a40246
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYd3afde78-b9f6-3648-e053-2a95a90a40246
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYd3afde78-b9f6-3648-e053-2a95a90a40246

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82355-550-018235505500120 PACKAGE in 1 PACKAGE (82355-550-01) / 1 mg in 1 PACKAGE20 package2021-12-210000-00-00NoNoCurrent
82355-550-028235505500220 PACKAGE in 1 PACKAGE (82355-550-02) / 1 mg in 1 PACKAGE20 package2021-12-210000-00-00NoNoCurrent