FDA.reportPublic FDA data

CoreTex Antibacterial Hand Sanitizer

Product NDC
65753-201
11-digit product format
657530201
Labeler code
65753
Product ID
65753-201_5cb86904-d0ce-0366-e063-6294a90a6f80
Type
HUMAN OTC DRUG
Nonproprietary name
SD alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
CoreTex Products Inc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65753-20165753-201-20DDiscontinued by firm2026-10-16
excluded packagepackage65753-20165753-201-21DDiscontinued by firm2026-10-16

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
CoreTex Antibacterial Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-201-01CoreTex Antibacterial Hand Sanitizer30 mL in 1 BOTTLELIQUID304
65753-201-02CoreTex Antibacterial Hand Sanitizer59 mL in 1 BOTTLELIQUID594
65753-201-03CoreTex Antibacterial Hand Sanitizer118 mL in 1 BOTTLELIQUID1184
65753-201-05CoreTex Antibacterial Hand Sanitizer237 mL in 1 BOTTLELIQUID2374
65753-201-06CoreTex Antibacterial Hand Sanitizer355 mL in 1 BOTTLELIQUID3554
65753-201-07CoreTex Antibacterial Hand Sanitizer354 mL in 1 BOTTLE, PUMPLIQUID3544
65753-201-10CoreTex Antibacterial Hand Sanitizer3800 mL in 1 BOTTLELIQUID38004
65753-201-20CoreTex Antibacterial Hand Sanitizer3.5 mL in 1 POUCHLIQUID3.54
65753-201-20CoreTex Antibacterial Hand Sanitizer25 in 1 CONTAINERLIQUID254
65753-201-21CoreTex Antibacterial Hand Sanitizer3.5 mL in 1 POUCHLIQUID3.54
65753-201-21CoreTex Antibacterial Hand Sanitizer300 in 1 CONTAINERLIQUID3004
65753-201-28CoreTex Antibacterial Hand Sanitizer118 mL in 1 BOTTLE, PUMPLIQUID1184
65753-201-29CoreTex Antibacterial Hand Sanitizer237 mL in 1 BOTTLE, PUMPLIQUID2374
65753-201-30CoreTex Antibacterial Hand Sanitizer473 mL in 1 BOTTLE, PUMPLIQUID4734
65753-201-32CoreTex Antibacterial Hand Sanitizer44 mL in 1 BOTTLELIQUID444
65753-201-35CoreTex Antibacterial Hand Sanitizer750 mL in 1 BOTTLELIQUID7504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-201CORETEX ANTIBACTERIAL HAND SANITIZER (SD ALCOHOL) LIQUID [CORETEX PRODUCTS INC]4Current NDC, 16 package rows20241204_136d8fe4-df26-c292-e063-6394a90afbec.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 109 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ethyl Rubbing Alcohol 70 PercentETHYL ALCOHOLPharma Nobis, LLCe42fccc2-1b50-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M003
Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLPharma Nobis, LLCe42f6c6d-c4e1-02c6-e053-2995a90a3ace2023-12-26WarningsExact identifier
application number: M003
CVS MerthiolateBENZALKONIUM CHLORIDECVS Pharmacydd498ab1-8350-41aa-86fc-2db57005f3e22023-12-22WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE 10%Pharma Nobis, LLCe42eee1b-3539-fb17-e053-2995a90af61d2023-12-22WarningsExact identifier
application number: M003
Decolorized IodineETHYL ALCOHOLPharma Nobis, LLCe21dd43b-3712-cb16-e053-2a95a90ac2762023-12-22WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70 PercentISOPROPYL ALCOHOLPharma Nobis, LLCe42f727c-beb0-fe9d-e053-2995a90aafea2023-12-22WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Pharma Nobis, LLCe42ee827-b350-7b56-e053-2a95a90a69cf2023-12-22WarningsExact identifier
application number: M003
MerthiolateBENZALKONIUM CHLORIDEPharma Nobis, LLCe42f727c-beaf-fe9d-e053-2995a90aafea2023-12-22WarningsExact identifier
application number: M003
Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLPharma Nobis, LLCe42f6c6d-c4e0-02c6-e053-2995a90a3ace2023-12-22WarningsExact identifier
application number: M003
RevitaDERM Wound CareBENZALKONIUM CHLORIDEBlaine Labs Inc.9254dada-4e32-43a0-892b-c488d68e23e72023-12-21WarningsExact identifier
application number: M003
NUMSTAT Antiseptic and Pain Relieving Prep PadALCOHOL, MENTHOL, AND BENZOCAINE PREP PADSpectra Medical Devices, LLC07d20040-9dd9-0aba-e063-6294a90ab7cf2023-12-20WarningsExact identifier
application number: M003
Health Mart IodidesALCOHOLStrategic Sourcing Services LLC8d9f2112-c678-4559-b567-9d6d287c5fa32023-12-20WarningsExact identifier
application number: M003
Health Mart Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLStrategic Sourcing Services LLC72eeb3e6-c0a1-4b18-87f1-8db06f9bd1112023-12-20WarningsExact identifier
application number: M003
Health Mart Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEStrategic Sourcing Services LLCcbe02fa1-c167-4b77-8f63-817362090e192023-12-20WarningsExact identifier
application number: M003
Health Mart Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLStrategic Sourcing Services LLCfbd2aa69-b1c7-4a28-9642-a436ae09faaf2023-12-20WarningsExact identifier
application number: M003
Quality Choice Povidone IodinePOVIDONE IODINE 10%Chain Drug Market Association9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d2023-12-20WarningsExact identifier
application number: M003
Quality Choice Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLChain Drug Market Association55c970ed-13a9-4ea2-a8cb-aaf14d3a214d2023-12-20WarningsExact identifier
application number: M003
Quality Choice Iodides TinctureETHYL ALCOHOLChain Drug Market Association71aedfd5-e81f-4b69-b163-527ff1ce30b12023-12-20WarningsExact identifier
application number: M003
Quality Choice MerthiolateBENZALKONIUM CHLORIDEChain Drug Market Association5b7303b9-b8c4-4e7c-876f-70ed764430552023-12-20WarningsExact identifier
application number: M003
Premier Value Povidone IodinePOVIDONE IODINE 10%Chain Drug Consortium5cc9d782-5f7e-27d9-e053-2991aa0a24282023-12-20WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSN136d8fe4-df26-c292-e063-6394a90afbec4
582753ethanol 0.7 ML/ML Topical SolutionSCD136d8fe4-df26-c292-e063-6394a90afbec4
582753ethanol 70 % Topical SolutionSY136d8fe4-df26-c292-e063-6394a90afbec4
582753ethyl alcohol 70 % Topical SolutionSY136d8fe4-df26-c292-e063-6394a90afbec4
1043353benzocaine 6 % Medicated PadPSNf57bc089-405b-cdcd-e053-2995a90a9d123
2263170camphor 0.1 % / diphenhydrAMINE HCl 2 % / zinc acetate 1 % Topical GelPSNf57bc089-405b-cdcd-e053-2995a90a9d123
582753ethanol 70 % Topical SolutionPSNf57bc089-405b-cdcd-e053-2995a90a9d123
2263166StingX 6 % Topical SwabPSNf57bc089-405b-cdcd-e053-2995a90a9d123
2263166benzocaine 60 MG/ML Medicated Pad [StingX]SBDf57bc089-405b-cdcd-e053-2995a90a9d123
1043353benzocaine 60 MG/ML Medicated PadSCDf57bc089-405b-cdcd-e053-2995a90a9d123
2263170camphor 0.001 MG/MG / diphenhydramine hydrochloride 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSCDf57bc089-405b-cdcd-e053-2995a90a9d123
582753ethanol 0.7 ML/ML Topical SolutionSCDf57bc089-405b-cdcd-e053-2995a90a9d123
1043353benzocaine 6 % Medicated WipeSYf57bc089-405b-cdcd-e053-2995a90a9d123
1043353benzocaine 6 % Topical SwabSYf57bc089-405b-cdcd-e053-2995a90a9d123
2263170camphor 0.001 MG/MG / diphenhydramine HCl 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical GelSYf57bc089-405b-cdcd-e053-2995a90a9d123
2263170camphor 0.1 % / diphenhydramine HCl 2 % / zinc acetate 1 % Topical GelSYf57bc089-405b-cdcd-e053-2995a90a9d123
582753ethanol 70 % Topical SolutionSYf57bc089-405b-cdcd-e053-2995a90a9d123
582753ethyl alcohol 70 % Topical SolutionSYf57bc089-405b-cdcd-e053-2995a90a9d123
2263166StingX 60 MG/ML Medicated PadSYf57bc089-405b-cdcd-e053-2995a90a9d123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65753-201-016575302010130 mL in 1 BOTTLE (65753-201-01) 30 ml2024-01-01NoNoCurrent
65753-201-026575302010259 mL in 1 BOTTLE (65753-201-02) 59 ml2024-01-01NoNoCurrent
65753-201-0365753020103118 mL in 1 BOTTLE (65753-201-03) 118 ml2024-01-01NoNoCurrent
65753-201-0565753020105237 mL in 1 BOTTLE (65753-201-05) 237 ml2024-01-01NoNoCurrent
65753-201-0665753020106355 mL in 1 BOTTLE (65753-201-06) 355 ml2024-01-01NoNoCurrent
65753-201-0765753020107354 mL in 1 BOTTLE, PUMP (65753-201-07) 354 ml2024-01-01NoNoCurrent
65753-201-10657530201103800 mL in 1 BOTTLE (65753-201-10) 3800 ml2024-01-01NoNoCurrent
65753-201-20657530201203.5 mL in 1 POUCH3.5 mlHistorical
65753-201-21657530201213.5 mL in 1 POUCH3.5 mlHistorical
65753-201-2865753020128118 mL in 1 BOTTLE, PUMP (65753-201-28) 118 ml2024-01-01NoNoCurrent
65753-201-2965753020129237 mL in 1 BOTTLE, PUMP (65753-201-29) 237 ml2024-01-01NoNoCurrent
65753-201-3065753020130473 mL in 1 BOTTLE, PUMP (65753-201-30) 473 ml2024-01-01NoNoCurrent
65753-201-326575302013244 mL in 1 BOTTLE (65753-201-32) 44 ml2024-01-01NoNoCurrent
65753-201-3565753020135750 mL in 1 BOTTLE (65753-201-35) 750 ml2024-01-01NoNoCurrent