FDA.reportPublic FDA data

Loris BZK

Product NDC
68356-126
Requested package NDC
68356-126-03
11-digit product format
683560126
Labeler code
68356
Product ID
68356-126_4c4e2cec-ba7a-093f-e063-6294a90ad793
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SWAB
Route
TOPICAL
Labeler
LernaPharm Loris Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-11-21
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100g
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
Loris BZK
Brand name suffix
Antiseptic Wipes
Listing expiration
2027-12-31

Active Ingredients#

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

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
a448de7b-4d96-4d53-ae1a-0bd38a2fb4a2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68356-126-01Loris BZKAntiseptic Wipes100 in 1 BOXSWAB10013
68356-126-01Loris BZKAntiseptic Wipes2.6 g in 1 PACKETSWAB2.613
68356-126-02Loris BZKAntiseptic Wipes2.6 g in 1 PACKETSWAB2.613
68356-126-03Loris BZKAntiseptic Wipes2.5 g in 1 APPLICATORSWAB2.513
68356-126-03Loris BZKAntiseptic Wipes3 in 1 PACKAGESWAB313
68356-126-04Loris BZKAntiseptic Wipes2.6 g in 1 PACKETSWAB2.613
68356-126-02Model AA-20122.6 g in 1 PACKETSWAB0.13 g in 1000.13 g in 100g3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7LORIS BZK ANTISEPTIC WIPES (BENZALKONIUM CHLORIDE) SWAB [LERNAPHARM LORIS INC.]8
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YLORIS BZK ANTISEPTIC WIPES (BENZALKONIUM CHLORIDE) SWAB [LERNAPHARM LORIS INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RLORIS BZK ANTISEPTIC WIPES (BENZALKONIUM CHLORIDE) SWAB [LERNAPHARM LORIS INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68356-126LORIS BZK ANTISEPTIC WIPES (BENZALKONIUM CHLORIDE) SWAB [LERNAPHARM LORIS INC.]12Current NDC, Legacy NDC, 6 package rows20231016_a448de7b-4d96-4d53-ae1a-0bd38a2fb4a2.zip
68356-126MODEL AA-2012 KIT [AEROSPACE ACCESSORY SERVICE]3Current NDC, Legacy NDC20241004_e29b0f92-27b7-e09f-e053-2995a90a35e3.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 98 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MED NAP Cleansing ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd92cd45a-234c-4872-e053-2a95a90a3e1c2024-11-09WarningsExact identifier
application number: M003
MED NAP Obstetrical ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd83d2fab-6972-9b18-e053-2995a90a5cb52024-11-09WarningsExact identifier
application number: M003
MED NAP Benzalkonium Chloride AntisepticBENZALKONIUM CHLORIDEAcme United Corporationd7c404c1-c765-a67c-e053-2995a90a6b8e2024-11-09WarningsExact identifier
application number: M003
Barbie BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.d675eb91-80a8-4874-a2b0-c2bf692649112024-11-08WarningsExact identifier
application number: M003
Barbie ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.a4a6beb0-5781-4d74-9120-7ca64e035c232024-11-08WarningsExact identifier
application number: M003
MARVEL ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.f6cd4757-d6e0-46bd-827f-3f380c71858f2024-11-07WarningsExact identifier
application number: M003
Instant Hand SanitizerHAND SANITIZERRaining Rose, Inc.2656d129-df88-4489-e063-6394a90a4b492024-11-07WarningsExact identifier
application number: M003
HealthWise Advanced Hand SanitizerETHYL ALCOHOL 70%Veridian Healthcare261bd056-c2f9-2a69-e063-6394a90af8df2024-11-04WarningsExact identifier
application number: M003
Hand Sanitizer Cucumber AloeORGANIC ETHYL ALCOHOLWhole Foods Market, Inc.0588ae1b-f29a-e1b6-e063-6394a90a0de12024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Cucumber AloeETHYL ALCOHOLWhole Foods Market, Inc.074334af-c26e-4126-e063-6394a90ae4c42024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Orange BlossomORGANIC ETHYL ALCOHOLWhole Foods Market, Inc.07f708d1-11c8-eb50-e063-6294a90a3a812024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer LavenderETHYL ALCOHOLWhole Foods Market, Inc.0742f251-5fc9-c015-e063-6394a90a79b12024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Orange BlossomETHYL ALCOHOLWhole Foods Market, Inc.07436407-7a15-7cee-e063-6294a90a96512024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer LavenderETHYL ALCOHOLWhole Foods Market, Inc.07f7e966-e57e-dede-e063-6294a90acbf52024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer LavenderETHYL ALCOHOLWhole Foods Market, Inc.ec8c7597-a3f1-65a8-e053-2995a90a69a12024-11-02WarningsExact identifier
application number: M003
Lemongrass Hand SanitizerALCOHOLNatural Essentials, Inc.25ca3908-24aa-5e4f-e063-6394a90a7a882024-10-31WarningsExact identifier
application number: M003
Sanar Naturals Decolorized IodineETHYL ALCOHOLSanvall Enterprises, Inc16c92427-84d2-cad5-e063-6394a90af4352024-10-31WarningsExact identifier
application number: M003
Sanar Naturals MercurochromeBENZALKONIUM CHLOLRIDESanvall Enterprises, Inc16c6c2f0-0f08-e640-e063-6394a90aa01d2024-10-31WarningsExact identifier
application number: M003
Sanar Naturals Gentian VioletGENTIAN VIOLETSanvall Enterprises, Inc1922518d-e49b-5010-e063-6394a90a91122024-10-31WarningsExact identifier
application number: M003
Lavender Hand SanitizerALCOHOLNatural Essentials, Inc.25cada8c-8c80-c140-e063-6294a90a33362024-10-31WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNa448de7b-4d96-4d53-ae1a-0bd38a2fb4a213
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDa448de7b-4d96-4d53-ae1a-0bd38a2fb4a213
1038558benzalkonium chloride 0.13 % Topical ClothSYa448de7b-4d96-4d53-ae1a-0bd38a2fb4a213
1038558benzalkonium chloride 0.13 % Topical SwabSYa448de7b-4d96-4d53-ae1a-0bd38a2fb4a213
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYa448de7b-4d96-4d53-ae1a-0bd38a2fb4a213
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYa448de7b-4d96-4d53-ae1a-0bd38a2fb4a213
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYa448de7b-4d96-4d53-ae1a-0bd38a2fb4a213
1038558benzalkonium chloride 0.13 % Medicated PadPSNe29b0f92-27b7-e09f-e053-2995a90a35e33
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDe29b0f92-27b7-e09f-e053-2995a90a35e33
1038558benzalkonium chloride 0.13 % Topical ClothSYe29b0f92-27b7-e09f-e053-2995a90a35e33
1038558benzalkonium chloride 0.13 % Topical SwabSYe29b0f92-27b7-e09f-e053-2995a90a35e33
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYe29b0f92-27b7-e09f-e053-2995a90a35e33
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYe29b0f92-27b7-e09f-e053-2995a90a35e33
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYe29b0f92-27b7-e09f-e053-2995a90a35e33
1038558benzalkonium chloride 0.13 % Medicated PadPSN61f1ba42-e27e-4d5f-bc1d-534cd359c7e82
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD61f1ba42-e27e-4d5f-bc1d-534cd359c7e82
1038558benzalkonium chloride 0.13 % Topical ClothSY61f1ba42-e27e-4d5f-bc1d-534cd359c7e82
1038558benzalkonium chloride 0.13 % Topical SwabSY61f1ba42-e27e-4d5f-bc1d-534cd359c7e82
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY61f1ba42-e27e-4d5f-bc1d-534cd359c7e82
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY61f1ba42-e27e-4d5f-bc1d-534cd359c7e82
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY61f1ba42-e27e-4d5f-bc1d-534cd359c7e82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68356-126-03683560126033 APPLICATOR in 1 PACKAGE (68356-126-03) / 2.5 g in 1 APPLICATOR3 applicator2012-11-210000-00-00NoNoCurrent