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 23 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPPIN DOTS HAND SANI BIRTHDAY CAKEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd520828a5-4e8d-b637-e063-6394a90ab4912026-05-01WarningsExact identifier
application number: M003
ICEE HAND SANI BLUE RASBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52089622-d9b5-b5cb-e063-6394a90ad4262026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208adea-27da-81a3-e063-6294a90afc802026-05-01WarningsExact identifier
application number: M003
ICEE HAND SANI CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52089622-d9b6-b5cb-e063-6394a90ad4262026-05-01WarningsExact identifier
application number: M003
KOOL AID HAND SANITIZER BUBBLE PINK LEMONADEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208bd2c-277c-648e-e063-6294a90a5b282026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANITIZER RAINBOW ICEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52092127-7a8d-5db3-e063-6294a90a07b52026-05-01WarningsExact identifier
application number: M003
Liquid death hand sanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd520943a4-0e63-a9ab-e063-6394a90ab2a92026-05-01WarningsExact identifier
application number: M003
Redicare Antiseptic TowelettesANTISEPTIC TOWELETTESRedicare LLC484c8ff5-cc11-b646-e063-6394a90a5f502026-05-01WarningsExact identifier
application number: M003
Redicare Alcohol Prep PadsMEDIUM ALCOHOL PREP PADSRedicare LLC3cb7fba1-1d2d-f4da-e063-6394a90a4b212026-05-01WarningsExact identifier
application number: M003
SCOTT Antiseptic Foam Skin CleanserCHLOROXYLENOLKimberly-Clarkca761935-7dcc-4caf-b941-60693a97c8a62026-04-30WarningsExact identifier
application number: M003
SCOTT FOAM HAND SANITIZERBENZALKONIUM CHLORIDEKimberly-Clark11234f21-04e4-4b16-88c3-51968a1cedca2026-04-30WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINERetail Business Services, LLCad4e49b6-5784-4880-950b-6e6175fc312b2026-04-30Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLYour Military Exchanges3dcb8422-827d-479b-ba18-eee8dbb762e12026-04-30Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDETarget Corporation33591569-8c56-4721-9d14-d9696f93c7932026-04-30Warnings, Adverse reactionsExact identifier
application number: M003
Oopsie 3 Hydrogen PeroxideHYDROGEN PEROXIDE4 Visions LLC50b0d82a-da2c-5fd0-e063-6294a90aa1652026-04-30WarningsExact identifier
application number: M003
Vita Vie Antibacterial WashBENZALKONIUM CHLORIDESpa De Soleila83883b7-9b63-641b-e053-2995a90ab9432026-04-30WarningsExact identifier
application number: M003
Dr Lift Advanced Antibacterial WipesBENZALKONIUM CHLORIDESpa de Soleilaf89bd25-784e-4828-e053-2995a90a8aaa2026-04-30WarningsExact identifier
application number: M003
Dr Lift Antibacterial Hand WashBENZALKONIUM CHLORIDESpa de Soleilab9e2c3c-d422-255e-e053-2a95a90a7a222026-04-30WarningsExact identifier
application number: M003
Dr Lift Antibacterial Body ScrubBENZALKONIUM CHLORIDESpa de Soleilab9d6c73-29c1-036a-e053-2995a90a449c2026-04-30WarningsExact identifier
application number: M003
KLEENEX Foam Hand SanitizerBENZALKONIUM CHLORIDEKimberly-Clark1fa77ae2-b652-463d-8943-d338c591226e2026-04-29WarningsExact 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