FDA.reportPublic FDA data

Coralite Antibacterial Moist

Product NDC
65923-831
11-digit product format
659230831
Labeler code
65923
Product ID
65923-831_427c16f0-d3c8-8ded-e063-6394a90a796e
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
United Exchange Corp.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-26
Substance
BENZALKONIUM CHLORIDE
Active strength
.115 g/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
Coralite Antibacterial Moist
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.115 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6245a83f-5c81-4ae6-bc6e-adfc46c37003Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-831-30Coralite Antibacterial Moist30 in 1 POUCHSOLUTION3011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7CORALITE ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SOLUTION [UNITED EXCHANGE CORP.]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YCORALITE ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SOLUTION [UNITED EXCHANGE CORP.]1
BRONOPOLINACTIVE INGREDIENT6PU1E16C9WCORALITE ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SOLUTION [UNITED EXCHANGE CORP.]1
CITRIC ACID ACETATEINACTIVE INGREDIENTDSO12WL7AUCORALITE ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SOLUTION [UNITED EXCHANGE CORP.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUCORALITE ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SOLUTION [UNITED EXCHANGE CORP.]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBCORALITE ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SOLUTION [UNITED EXCHANGE CORP.]1
LAURYL GLUCOSIDEINACTIVE INGREDIENT76LN7P7UCUCORALITE ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SOLUTION [UNITED EXCHANGE CORP.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCORALITE ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SOLUTION [UNITED EXCHANGE CORP.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHCORALITE ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SOLUTION [UNITED EXCHANGE CORP.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CORALITE ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SOLUTION [UNITED EXCHANGE CORP.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCORALITE ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SOLUTION [UNITED EXCHANGE CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-831CORALITE ANTIBACTERIAL MOIST (BENZALKONIUM CHLORIDE) SOLUTION [UNITED EXCHANGE CORP.]9Current NDC, Legacy NDC, 1 package rows20241222_6245a83f-5c81-4ae6-bc6e-adfc46c37003.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 65 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHERK SANITIZER GREEN APPLEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3f03af0d-b1a6-8fd1-e063-6294a90ad0912025-09-17WarningsExact identifier
application number: M003
SHERK SANITIZER WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3f03d420-e41f-a923-e063-6294a90ab6d32025-09-17WarningsExact identifier
application number: M003
Hand Sanitizer plus HolderBENZALKONIUM CHLORIDEGertex Hosierya182eafa-0ce0-4b99-bcb0-23f9a8de9e1f2025-09-17WarningsExact identifier
application number: M003
Booboo BubblesHYDROGEN PEROXIDE72 Seasons LLC3e8b538c-d4d6-7d76-e063-6394a90a96d12025-09-15WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Champagne AppleETHYL ALCOHOL 70%MY IMPORTS USA LLC3ece368e-1c98-6275-e063-6294a90a1dec2025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Caramel CinnamonETHYL ALCOHOL 70%MY IMPORTS USA LLC3ece74d3-fec4-55cc-e063-6394a90afda92025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CascadeETHYL ALCOHOL 70%MY IMPORTS USA LLC3ece4de7-4c1c-5dde-e063-6294a90ae56e2025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Jasmine ShadeETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf17c6-3a97-7dc5-e063-6294a90a85c62025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Dragon FruitETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf0c05-15f2-cf9e-e063-6294a90ab8462025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Cherry BerryETHYL ALCOHOL 70%MY IMPORTS USA LLC3eced383-2f0b-3c0d-e063-6394a90afce42025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Mango PapayaETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf2280-56e6-4770-e063-6394a90a3e3c2025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Ocean BreezeETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf411b-2748-7296-e063-6394a90a3bec2025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Petal CascadeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC3ecf4668-3ece-a665-e063-6394a90afe122025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Salted CaramelETHYL ALCOHOL 70%MY IMPORTS USA LLC3ecf534b-c865-1e80-e063-6394a90a245b2025-09-14WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Salted CaramelETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e93d14e-38a1-af85-e063-6394a90af14c2025-09-12WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Ocean BreezeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e927c78-3295-9484-e063-6294a90a2ed42025-09-11WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Petal CascadeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.3e92fc21-e96c-a6ac-e063-6294a90a88052025-09-11WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Cherry BerryETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.3e6c959e-62cf-ec7c-e063-6294a90a0b122025-09-10WarningsExact identifier
application number: M003
Smart Care Kids Hand Sanitizer TransformersALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e6debb9-8eeb-c82f-e063-6394a90a89f52025-09-10WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e6e665b-78d8-bf9c-e063-6394a90a4acc2025-09-10WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-831-306592308313030 SOLUTION in 1 POUCH (65923-831-30) 30 solution2013-09-260000-00-00NoNoCurrent