FDA.reportPublic FDA data

WIPES4HEALTH

Product NDC
80976-100
11-digit product format
809760100
Labeler code
80976
Product ID
80976-100_e879b8f2-5e01-46a2-8550-922214687d59
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Bubble Marketing LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-04
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
WIPES4HEALTH
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
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
5d6dd15b-d087-4f25-bd2b-035ecacd5f97Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
80976-100-012024-08-26SANITIZING wipes 4 health
80976-100-012024-08-26SANITIZING wipes 4 health
80976-100-022024-08-26SANITIZING wipes 4 health
80976-100-022024-08-26SANITIZING wipes 4 health
80976-100-032024-08-26SANITIZING wipes 4 health
80976-100-032024-08-26SANITIZING wipes 4 health
80976-100-042024-08-26SANITIZING wipes 4 health
80976-100-042024-08-26SANITIZING wipes 4 health
80976-100-052024-08-26SANITIZING wipes 4 health
80976-100-052024-08-26SANITIZING wipes 4 health
80976-100-012024-07-30SANITIZING wipes 4 health
80976-100-012024-07-30SANITIZING wipes 4 health
80976-100-022024-07-30SANITIZING wipes 4 health
80976-100-022024-07-30SANITIZING wipes 4 health
80976-100-032024-07-30SANITIZING wipes 4 health
80976-100-032024-07-30SANITIZING wipes 4 health
80976-100-042024-07-30SANITIZING wipes 4 health
80976-100-042024-07-30SANITIZING wipes 4 health
80976-100-052024-07-30SANITIZING wipes 4 health
80976-100-052024-07-30SANITIZING wipes 4 health
80976-100-012024-01-30SANITIZING wipes 4 health
80976-100-012024-01-30SANITIZING wipes 4 health
80976-100-022024-01-30SANITIZING wipes 4 health
80976-100-022024-01-30SANITIZING wipes 4 health
80976-100-032024-01-30SANITIZING wipes 4 health
80976-100-032024-01-30SANITIZING wipes 4 health
80976-100-042024-01-30SANITIZING wipes 4 health
80976-100-042024-01-30SANITIZING wipes 4 health
80976-100-052024-01-30SANITIZING wipes 4 health
80976-100-052024-01-30SANITIZING wipes 4 health

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80976-100-01WIPES4HEALTH3.15 mL in 1 PACKAGECLOTH3.1513
80976-100-01WIPES4HEALTH1000 in 1 BAGCLOTH100013
80976-100-02WIPES4HEALTH3.15 mL in 1 PACKAGECLOTH3.1513
80976-100-02WIPES4HEALTH1250 in 1 BAGCLOTH125013
80976-100-03WIPES4HEALTH160 in 1 BAGCLOTH16013
80976-100-03WIPES4HEALTH3.15 mL in 1 PACKAGECLOTH3.1513
80976-100-04WIPES4HEALTH800 in 1 BAGCLOTH80013
80976-100-04WIPES4HEALTH3.15 mL in 1 PACKAGECLOTH3.1513
80976-100-05WIPES4HEALTH3.15 mL in 1 PACKAGECLOTH3.1513
80976-100-05WIPES4HEALTH80 in 1 BAGCLOTH8013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80976-100WIPES4HEALTH (BENZALKONIUM CHLORIDE) CLOTH [BUBBLE MARKETING LLC]10Current NDC, Legacy NDC, 10 package rows20241220_5d6dd15b-d087-4f25-bd2b-035ecacd5f97.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 11 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Scentfull Hand Sanitizer Pink ChampagneALCOHOLScent Theory Products LLC565650e6-e5f9-c010-e063-6394a90aacfa2026-07-11WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Blue DriftwoodALCOHOLScent Theory Products LLC56572ebe-d624-6389-e063-6394a90a23b42026-07-11WarningsExact identifier
application number: M003
Humco Gentian Violet 1%GENTIAN VIOLET 1%Humco Holding Group, Inc.7b4e6572-cb44-491d-8063-f7519307a8e52026-07-09WarningsExact identifier
application number: M003
Gentian Violet 1%GENTIAN VIOLET 1%Pharma Nobis, LLCe42fa7d2-47ef-0e82-e053-2995a90a67c52026-07-09WarningsExact identifier
application number: M003
Humco Gentian Violet 2%GENTIAN VIOLET 2%Humco Holding Group, Inc.a07f61e5-0215-419a-a68a-1d814417c35f2026-07-09WarningsExact identifier
application number: M003
GNP Gentian Violet 1%GENTIAN VIOLET 1%Amerrisource Bergen5d07274f-e848-6c60-e053-2991aa0a40d82026-07-09WarningsExact identifier
application number: M003
Drs pharmacy triple antibiotic Pain plus itch plus ScarBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLC16273878-2f58-0d26-e063-6394a90a47d22026-07-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic Plus Pain reliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACY1626fa89-cec0-6467-e063-6294a90aa2a42026-07-09WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC56148c12-7d6f-26bf-e063-6294a90a93df2026-07-08WarningsExact identifier
application number: M003
Povidone-IodinePOVIDONE-IODINECARDINAL HEALTH 110, LLC. DBA LEADER4f0d8da5-a75b-acc7-e063-6394a90ae8392026-07-08WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.5600cf8a-5aba-1a22-e063-6394a90a80832026-07-07WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink SugarETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5600dc30-192d-19b1-e063-6394a90a66d32026-07-07WarningsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLSave-A-Lot Food Stores Ltda592326c-c062-4ebf-b8dd-83f7e6f2f22b2026-07-07Warnings, Adverse reactionsExact identifier
application number: M003
Amazon Basics Citrus Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC52e5b1a4-3a84-c4cb-e063-6394a90a822c2026-07-07WarningsExact identifier
application number: M003
Amazon Basics Fresh Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC5256f38a-74b6-0d18-e063-6294a90a5b462026-07-07WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLEverywhereAire LLCb48f9e6b-c616-3607-e053-2995a90a37f52026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands hand sanitizerETHYL ALCOHOLEverywhereAire LLCb6af3009-78c2-2312-e053-2995a90af90a2026-07-06WarningsExact identifier
application number: M003
Hand Sanitizer gelALCOHOLEverywhereAire LLCd2a6c866-3f1e-20f1-e053-2995a90a26cc2026-07-06WarningsExact identifier
application number: M003
PlaneAire HandsHAND SANITIZER ETHANOL-BASEDEverywhereAire LLCeab3ab67-cb27-6c2b-e053-2a95a90ace122026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands SandalwoodETHANOL HAND SANITIZEREverywhereAire LLC18612a10-8667-b0ef-e063-6394a90a208e2026-07-06WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN5d6dd15b-d087-4f25-bd2b-035ecacd5f9713
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD5d6dd15b-d087-4f25-bd2b-035ecacd5f9713
1038558benzalkonium chloride 0.13 % Topical ClothSY5d6dd15b-d087-4f25-bd2b-035ecacd5f9713
1038558benzalkonium chloride 0.13 % Topical SwabSY5d6dd15b-d087-4f25-bd2b-035ecacd5f9713
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY5d6dd15b-d087-4f25-bd2b-035ecacd5f9713
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY5d6dd15b-d087-4f25-bd2b-035ecacd5f9713
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY5d6dd15b-d087-4f25-bd2b-035ecacd5f9713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80976-100-01809760100011000 PACKAGE in 1 BAG (80976-100-01) / 3.15 mL in 1 PACKAGE1000 package2020-11-040000-00-00NoNoCurrent
80976-100-02809760100021250 PACKAGE in 1 BAG (80976-100-02) / 3.15 mL in 1 PACKAGE1250 package2020-11-040000-00-00NoNoCurrent
80976-100-0380976010003160 PACKAGE in 1 BAG (80976-100-03) / 3.15 mL in 1 PACKAGE160 package2020-11-040000-00-00NoNoCurrent
80976-100-0480976010004800 PACKAGE in 1 BAG (80976-100-04) / 3.15 mL in 1 PACKAGE800 package2020-11-040000-00-00NoNoCurrent
80976-100-058097601000580 PACKAGE in 1 BAG (80976-100-05) / 3.15 mL in 1 PACKAGE80 package2020-11-040000-00-00NoNoCurrent
80976-100-0680976010006400 PACKAGE in 1 BAG (80976-100-06) > 3.15 mL in 1 PACKAGE400 package2021-02-050000-00-00NoNoCurrent