FDA.reportPublic FDA data

Antibacterial

Product NDC
69790-640
11-digit product format
697900640
Labeler code
69790
Product ID
69790-640_593e23b9-1922-c3d5-e063-6294a90aa5ac
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Uline
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-12
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100mL
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
Antibacterial
Listing expiration
2027-12-31

Active Ingredients#

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

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
1046593Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
92730c66-127f-c90b-e053-2995a90a4823Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69790-640-072022-01-31ULine F640F
69790-640-072022-01-31ULine F640F
69790-640-242022-01-31ULine F640F
69790-640-242022-01-31ULine F640F
69790-640-312022-01-31ULine F640F
69790-640-312022-01-31ULine F640F
69790-640-072022-01-28ULine F640F
69790-640-072022-01-28ULine F640F
69790-640-242022-01-28ULine F640F
69790-640-242022-01-28ULine F640F
69790-640-312022-01-28ULine F640F
69790-640-312022-01-28ULine F640F

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 21 of 21 · 415 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BacitracinBACITRACINProficient Rx LP65f8fd49-1882-4eac-9c0e-d63968da33d42023-12-01WarningsExact identifier
application number: M004
Genuine First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEGFA Production(Xiamen) Co.,Ltd0aaee474-cf35-8b39-e063-6294a90a815c2023-11-21WarningsExact identifier
application number: M004
Sheffield Bacitracin ZincBACITRACIN ZINCSheffield Pharmaceuticals LLC0f446f48-f55d-4de7-b447-285d7a329c842023-11-20WarningsExact identifier
application number: M004
Sheffield Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDESheffield Pharmaceuticals LLC485a779c-017b-4064-a446-e5073c1bdb072023-11-20WarningsExact identifier
application number: M004
BacitracinBACITRACINBluePoint Laboratoriesb4d8ef06-6269-68f7-e053-2995a90ac8ea2023-11-17WarningsExact identifier
application number: M004
Bacitracin ZincFIRST AID ANTIBIOTICBluePoint Laboratoriesd914abe1-5e14-5673-e053-2a95a90ac91b2023-11-17WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVERLIT GLOBAL INC.e9157891-fc05-41a1-8a86-761a9ae56f8a2023-11-14WarningsExact identifier
application number: M004
CR-371059 Tolnaftate 1%CR-371059 TOLNAFTATE 1%A-S Medication Solutionsbb4e4612-850c-4863-954d-7ad0500b9c052023-11-01WarningsExact identifier
application number: M004
Isopropyl AlcoholISOPROPYL ALCOHOLA-S Medication Solutionsb44b07a0-91ff-476a-ae0a-080fa01917772023-10-31WarningsExact identifier
application number: M004
Family wellnessBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFRONT PHARMACEUTICAL PLCbd3b8146-6271-488d-bf79-0bb659123b312023-10-27WarningsExact identifier
application number: M004
Family WellnessBACITRACIN ZINCFRONT PHARMACEUTICAL PLCdfc148c1-d1bb-4230-b8cf-9457b99d4e8a2023-10-27WarningsExact identifier
application number: M004
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
application number: M004
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69790-640-07697900640073785 mL in 1 BOTTLE (69790-640-07) 3785 ml2017-09-120000-00-00NoNoCurrent
69790-640-24697900640241000 mL in 1 BAG (69790-640-24) 1000 ml2017-09-120000-00-00NoNoCurrent
69790-640-31697900640311000 mL in 1 BAG (69790-640-31) 1000 ml2017-09-120000-00-00NoNoCurrent