FDA.reportPublic FDA data

Loris BZK

Product NDC
68356-126
Requested package NDC
68356-126-01
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68356-12668356-126-01DDiscontinued by firm2026-10-16

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 97 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Only Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporationd71047f6-1353-c758-e053-2995a90a962c2024-11-26WarningsExact identifier
application number: M003
First Aid Only Alcohol Antiseptic PadISOPROPYL ALCOHOLAcme United Coporationa01fec1b-1339-40b9-e053-2995a90aeda52024-11-23WarningsExact identifier
application number: M003
Med-Nap Sterile Alcohol Prep PadsISOPROPYL ALCOHOLAcme United Corporationc6eff57b-d537-69c8-e053-2a95a90adc3a2024-11-23WarningsExact identifier
application number: M003
First Aid Only Alcohol AntisepticISOPROPYL ALCOHOLAcme United Corporationa810e723-ad0c-8c71-e053-2995a90a0acc2024-11-23WarningsExact identifier
application number: M003
Universal 50% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC0dcc9bd2-aea5-4c27-9956-47d56221726b2024-11-22WarningsExact identifier
application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC9a9d42ad-79d5-4acc-b5d9-cb7468961d472024-11-22WarningsExact identifier
application number: M003
Universal 50% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC044a6287-f568-4cfa-a813-7fc0e6ffc3522024-11-22WarningsExact identifier
application number: M003
NEXXGEN 70% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLCce73ac48-c5af-4a35-950c-62ff0232aa302024-11-22WarningsExact identifier
application number: M003
Universal 70% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLCd8b9b0e7-2cb8-4fc5-af55-790e64d6cfe82024-11-22WarningsExact identifier
application number: M003
Alcohol sterileISOPROPYL ALCOHOLCardinal Health, Incbb7c530f-5d80-4158-b715-09c1c837299d2024-11-21WarningsExact identifier
application number: M003
Alcohol sterileISOPROPYL ALCOHOLCardinal Health 200 LLC10135db9-f614-4511-96ac-faa6a02a1b612024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdd9f35c14-2f5a-4e1a-bc2b-a7e1631342132024-11-21WarningsExact identifier
application number: M003
Povidone-lodine Swabsticks TriplePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd74e70ea9-640b-4295-a40f-56f65fca13002024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd37f10b1f-b73c-4d71-91c2-1252f3d9d4ce2024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd1936d749-bf38-a433-e063-6294a90aba8c2024-11-21WarningsExact identifier
application number: M003
Maokang 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd7c17ce40-0358-44ff-aa60-53711666914b2024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd11390854-9e72-40a2-9c89-3c29a585dced2024-11-21WarningsExact identifier
application number: M003
Instant Hand Sanitizeing WipeISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTSShandong Yayun Sanitary Products Co., Ltd.aa0dc01a-2c6b-7402-e053-2a95a90af6a22024-11-21WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Prep SolutionPOVIDONE IODINE PREP SOLUTIONDynarex Corporation6bb4d55b-2be7-3549-e053-2a91aa0a2bb02024-11-20WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Surgical ScrubPOVIDONE IODINE SURGICAL SCRUB SOLUTIONDynarex Corporation6f053e55-cbf6-9072-e053-2991aa0a2edd2024-11-20WarningsExact 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
68356-126-0168356012601100 PACKET in 1 BOX (68356-126-01) > 2.6 g in 1 PACKET100 packet2012-11-210000-00-00NoNoCurrent