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 52 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMORA Spray. Hand Sanitizer coconutALCOHOLLongway Technology(Guangzhou) Co., Ltd.44fcf3d3-439b-7869-e063-6294a90a19c32025-12-02WarningsExact identifier
application number: M003
MedPride Instant SanitizerALCOHOLSHIELD LINE LLCa1c87c06-d4d2-cd0f-e053-2995a90a4eaa2025-12-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Caramel HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.450401c9-2098-9a23-e063-6394a90a20842025-12-02WarningsExact identifier
application number: M003
AMORA Spray. Hand Sanitizer CherryALCOHOLLongway Technology(Guangzhou) Co., Ltd.44e04959-a21e-ba62-e063-6394a90a71922025-12-01WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLL&R Distributors, Inc.263457cc-35ff-62fb-e063-6394a90a94da2025-12-01WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLL&R Distributors, Inc.2507df2c-9069-01c1-e063-6394a90a85962025-12-01WarningsExact identifier
application number: M003
T.N. Dickinsons Wound CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HYDROCHLORIDEDickinson Brands Inc.c2a8b134-8bb3-4e00-9df4-3229cb372da02025-12-01WarningsExact identifier
application number: M003
safeHands Hand Sanitizer Clean LinenBENZALKONIUM CHLORIDESafehands Distribution Ne, LLC86cc04dc-b66d-4d97-b8da-f5e41f2d13d52025-11-29WarningsExact identifier
application number: M003
safeHands Hand Sanitizer Fragrance FreeBENZALKONIUM CHLORIDESafehands Distribution Ne, LLC0e7af9f7-80a1-4347-89c4-7d9c8b55d65d2025-11-29WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC5376a031-b657-47d4-bf41-c393fdec040b2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC2298e131-3b0c-4104-bf48-5c366d763d452025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCbe8b96a2-c4a2-41f8-959b-0fe349cff37e2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCb35cb3d0-1a2d-4ffc-a32e-faa2ca1312ee2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCcef2d3d4-bd5f-4f2a-bb2d-5292b78501c12025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC90d6fe21-7b41-4429-8c03-4d35e66a3b292025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC87aaabb6-d121-464f-993d-5182de13d49e2025-11-28WarningsExact identifier
application number: M003
FF SILICONE SPRY SANI PPKFF SILICONE SPRY SANI PPKZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD4493c534-187e-f680-e063-6294a90aacdb2025-11-27WarningsExact identifier
application number: M003
Walgreen Maximum strength pain relieving cleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWALGREENS CO.9a0443a2-f1a9-482d-b5ee-abe983e4ae322025-11-26WarningsExact identifier
application number: M003
WalgreensFIRST AID ANTISEPTICWalgreensae731d28-8530-4dd0-aef7-b25f784b47772025-11-26WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.44677bab-41ea-3392-e063-6394a90a61872025-11-25WarningsExact 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