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 102 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC2216a551-9fbe-3721-e063-6294a90af13d2024-09-14WarningsExact identifier
application number: M003
Danielle Creations Hand Sanitizer - StrawberryALCOHOLGanzhou Olivee Cosmetic Co., Ltd.7c4bab88-af65-48c2-8440-3ba7b139c0132024-09-10WarningsExact identifier
application number: M003
Danielle Creations Hand Sanitizer - AppleALCOHOLGanzhou Olivee Cosmetic Co., Ltd.362d3233-79ac-41d8-9991-b5fc75c6cae92024-09-10WarningsExact identifier
application number: M003
Danielle Creations Hand Sanitizer - PeachALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ad28fe19-2b81-40c2-8ffb-f9b09c79def82024-09-10WarningsExact identifier
application number: M003
Thompson AntisepticBENZALKONIUM CHLORIDEThompson0c009ed0-23b8-e4b3-e063-6394a90a723d2024-09-04WarningsExact identifier
application number: M003
Bravo Sierra - Antibacterial Body WipesBENZALKONIUM CHLORIDE WIPESUnderscore USA20ed5566-9014-e35b-e063-6294a90a003a2024-08-30WarningsExact identifier
application number: M003
BERRIS AND CREAMY SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.30fc7f33-238c-42a3-93a1-72b98d303d9a2024-08-28WarningsExact identifier
application number: M003
MANGO SORBET SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.d44e43e1-717d-47a1-a152-45f12288cbd22024-08-28WarningsExact identifier
application number: M003
COCONUT VANILLA SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.574324ee-d98b-4939-889c-21ed04a4e46d2024-08-28WarningsExact identifier
application number: M003
STRAWBERRY SHORTCAKE SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.997d0ff0-96b4-4b91-87fc-8f67d9b5013c2024-08-28WarningsExact identifier
application number: M003
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.202dfeac-6e69-8667-e063-6294a90a26d22024-08-21WarningsExact identifier
application number: M003
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.202e5c15-8749-0a76-e063-6294a90a27202024-08-21WarningsExact identifier
application number: M003
Be Smart Get Prepared Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUSTotal Resources International, Inceacb5138-4af8-4550-b883-5603ad96ed7d2024-08-16WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine AntisepticPOVIDONE-IODINEAcme United Corporatione0052ac2-4f74-32a4-e053-2995a90a94c62024-08-13WarningsExact identifier
application number: M003
Keep Going Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.36c11178-b70f-4355-8823-c2b72598dae52024-08-08WarningsExact identifier
application number: M003
Keep Going Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.6b7400d5-d4b8-4b68-b048-c1917cdf3ce32024-08-08WarningsExact identifier
application number: M003
Keep Going Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.f67dd10c-746f-4c21-92f1-741f86218a692024-08-08WarningsExact identifier
application number: M003
Sugar Cookie Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efc0e9e-b4eb-d2b0-e063-6394a90a77792024-08-06WarningsExact identifier
application number: M003
Lemon Lime Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efe7236-d7bd-2a1c-e063-6294a90a736e2024-08-06WarningsExact identifier
application number: M003
Maokang Medical 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd644e92c3-3043-4a76-9845-7e0482cf9f622024-07-19WarningsExact 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