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 29 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Sanitizing WipesWALGREENS SANITIZING WIPESWalgreens42de3b25-692b-eaff-e063-6294a90a0d212026-03-11WarningsExact identifier
application number: M003
70% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC106f51fa-e687-470f-8ed8-35cb0565aeff2026-03-11Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC4ab76d25-136d-45e2-b9d7-964777e1d8552026-03-11Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEPerrigo Direct, Inc2efcda54-b8b7-4266-89c0-7f686c7afdca2026-03-11Warnings, Adverse reactionsExact identifier
application number: M003
Alcohol Antiseptic PadsISOPROPYL ALCOHOLAcme United Corporation4cc307b9-aee2-3ce0-e063-6294a90aa1692026-03-11WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLSalado Sales Inc.30294cad-d806-4d5b-8c86-484f22d214b62026-03-10Warnings, Adverse reactionsExact identifier
application number: M003
mild iodine tinctureIODINE AND SODIUM IODINE AND ALCOHOLKROGER COMPANY42762471-e5cb-505e-e063-6294a90afb7d2026-03-10WarningsExact identifier
application number: M003
Numstat Antiseptic and Pain-Relieving Prep PadANTISEPTIC AND PAIN-RELIEVING PREP PADSafetec of America Inc.4c9c20f2-bc17-857b-e063-6394a90a5d5c2026-03-09WarningsExact identifier
application number: M003
Eco Bandage OCEANBENZETHONIUM CHLORIDEECO Bandage LLCc7867df0-e167-4ec6-921b-6a0fb3cb06142026-03-06WarningsExact identifier
application number: M003
Eco Bandage HONEYBENZETHONIUM CHLORIDEEco Bandage LLCd2faa027-b274-43c0-9b87-85efab89fe8e2026-03-06WarningsExact identifier
application number: M003
Eco Bandage HIBISCUSBENZETHONIUM CHLORIDEEco Bandage LLC41f8716d-a970-40cd-a29d-69dafc97def82026-03-06WarningsExact identifier
application number: M003
Eco Bandage MOCHABENZETHONIUM CHLORIDEEco Bandage LLC11ec42e4-49d1-4690-80c3-784f2e30acd32026-03-06WarningsExact identifier
application number: M003
Eco Bandage SANDBENZETHONIUM CHLORIDEEco Bandage LLC5c620696-e8eb-445e-b746-5348ea37a2142026-03-06WarningsExact identifier
application number: M003
Eco Bandage sand oceanBENZETHONIUM CHLORIDEEco Bandage LLCda0c2d07-bc2a-4e7c-af45-f921375b52e12026-03-06WarningsExact identifier
application number: M003
MediChoice Antiseptic Isopropyl Alcohol Prep PadsISOPROPYL ALCOHOLO&M HALYARD, INC.20b3694e-04c7-4bca-b2ce-62ae0dec7a832026-03-05WarningsExact identifier
application number: M003
MediChoice Alcohol SwabstickISOPROPYL ALCOHOLO&M HALYARD, INC.7f78529d-df17-44b3-a890-1afa35308c672026-03-05WarningsExact identifier
application number: M003
MediChoice Alcohol Prep PadsISOPROPYL ALCOHOLO&M HALYARD, INC.f4f54448-0de0-448c-9b7b-104370953ae52026-03-05WarningsExact identifier
application number: M003
MediChoice Alcohol SwabstickISOPROPYL ALCOHOLO&M HALYARD, INC.7cee1141-4a49-4fec-a627-91a88e3d3ffc2026-03-05WarningsExact identifier
application number: M003
Loris BZK Antiseptic WipesBENZALKONIUM CHLORIDELernaPharm Loris Inc.a448de7b-4d96-4d53-ae1a-0bd38a2fb4a22026-03-05WarningsExact identifier
application number: M003
SPA HAND SANITIZER WRTER MELON SPLASHETHYL ALCOHOLRejoice International Corp.4c53620d-01ee-8ddd-e063-6294a90a8a2b2026-03-05WarningsExact 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