FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
64646-420
11-digit product format
646460420
Labeler code
64646
Product ID
64646-420_423860eb-e21a-a64a-e063-6294a90a7069
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Charlotte Products Ltd.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-10
Substance
ALCOHOL
Active strength
75 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64646-420IInactivated by FDA2026-10-12
excluded packagepackage64646-42064646-420-03IInactivated by FDA2026-10-12
excluded packagepackage64646-42064646-420-75IInactivated by FDA2026-10-12

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
Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL75 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1098198Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1fbfe3f9-e0db-a3a2-e063-6294a90ab6aaAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64646-420-032026-01-29C16284748780-149896155-a8f9-586f-e063-e6dba90add90Enviro Solutions ES42 Foaming Hand Sanitizer
64646-420-752026-01-29C16284748780-149896155-a8f9-586f-e063-e6dba90add90Enviro Solutions ES42 Foaming Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64646-420-04Hand Sanitizer1250 mL in 1 BOTTLE, DISPENSINGSOLUTION12506
64646-420-12Hand Sanitizer575 mL in 1 BOTTLE, PUMPSOLUTION5756
64646-420-03Hand Sanitizer3780 mL in 1 BOTTLE, DISPENSINGSOLUTION37805
64646-420-75Hand Sanitizer750 mL in 1 BOTTLE, DISPENSINGSOLUTION7505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64646-420HAND SANITIZER (ALCOHOL) SOLUTION [CHARLOTTE PRODUCTS LTD.]5Current NDC, Legacy NDC, 2 package rows20241213_1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa.zip
64646-420HAND SANITIZER (ALCOHOL) SOLUTION [CHARLOTTE PRODUCTS LTD.]5Current NDC, Legacy NDC, 2 package rows20241031_cb08bfc9-008f-4770-e053-2995a90a65ae.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 5 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraSealDIMETHICONEBausch Health US, LLC2c8dc616-20c1-4d33-8a89-9bcdb22b35c82024-10-17WarningsExact identifier
application number: M014
fungoid tinctureMICONAZOLE NITRATEPedinol Pharmacal, Inc.250d0a66-01d1-4aba-8f24-4cb4ca529fda2024-10-17WarningsExact identifier
application number: M014
GenRx Anti-Bacterial GelALCOHOLPureTek Corporationa124e37e-1a44-212a-e053-2995a90a0af02024-10-01WarningsExact identifier
application number: M014
Hand Sanitizing with Lavender OilALCOHOLPureTek Corporationa75d25a7-1e23-717f-e053-2a95a90a6d932024-10-01WarningsExact identifier
application number: M014
Leader Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDECardinal Health, Inc.0022a174-8377-44af-84a9-31adb27de1312024-08-23WarningsExact identifier
application number: M014
Leader Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDECardinal Health 110 DBA Leader36c1408b-4287-4e9f-aa17-4f05add500382024-08-12WarningsExact identifier
application number: M014
Major Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDEMajor Pharmaceuticals513bf82e-a36f-49d0-ba74-c834fea4f3b52024-08-12WarningsExact identifier
application number: M014
Alcohol WipesWIPE EM ALCOHOL WIPESShaoxing Elite Bio-Tech Co., Ltd.1f373096-d3d5-af7f-e063-6394a90a3b552024-08-08WarningsExact identifier
application number: M014
Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDENuCare Pharmaceuticals,Inc.b55acec6-5a4d-08b7-e053-2995a90a0f742024-07-17WarningsExact identifier
application number: M014
BacitracinBACITRACINNuCare Pharmaceuticals,Inc.a526ae4b-baae-5d50-e053-2a95a90ae2932024-07-17WarningsExact identifier
application number: M014
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals, Inc.54241254-1d9a-346a-e054-00144ff8d46c2024-07-17WarningsExact identifier
application number: M014
Dr Sheffield Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals,Inc.5786a559-a387-120d-e053-2991aa0ab6472024-07-15WarningsExact identifier
application number: M014
CVS Health Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDECVS Pharmacy, Inc.42a22e06-1b66-4359-852c-7c39e1b3940a2024-06-24WarningsExact identifier
application number: M014
TolnaftateTOLNAFTATENuCare Pharmaceuticals,Inc.63665de7-8415-651f-e053-2991aa0ac2bb2024-06-06WarningsExact identifier
application number: M014
Rite Aid Earwax Removal DropsCARBAMIDE PEROXIDERite Aid1262531e-0674-cf32-e063-6294a90a0d0b2024-05-10WarningsExact identifier
application number: M014
Debrox KidsISOPROPYL ALCOHOLMedtech Products Inc.f42eee70-c4ee-44ad-85d5-a06d98ecb8b02024-05-09WarningsExact identifier
application number: M014
Rite Aid Swimmers Ear DropsISOPROPYL ALCOHOLRite Aid12875b9d-3ae8-bd0c-e063-6294a90ab4ae2024-02-29WarningsExact identifier
application number: M014
Topcare Swimmers Ear DropsISOPROPYL ALCOHOLTopco Associates LLC0fddeb43-fee0-d43c-e063-6394a90a738a2024-01-26WarningsExact identifier
application number: M014
NeilMed Clear Canal Earwax Removal kitCARBAMIDE PEROXIDENEILMED PHARMACEUTICALS INCd330552d-07b6-f01e-e053-2a95a90a7ca52024-01-11WarningsExact identifier
application number: M014
Wax Out PlusCARBAMIDE PEROXIDE DROPSNEILMED PHARMACEUTICALS INCcf64f4b8-279c-8c1d-e053-2995a90ac8532024-01-11WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098198ethanol 75 % Topical FoamPSN1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa6
1098198ethanol 0.75 ML/ML Topical FoamSCD1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa6
1098198ethanol 75 % Topical FoamSY1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa6
1098198ethanol 75 % Topical FoamPSNcb08bfc9-008f-4770-e053-2995a90a65ae5
1098198ethanol 0.75 ML/ML Topical FoamSCDcb08bfc9-008f-4770-e053-2995a90a65ae5
1098198ethanol 75 % Topical FoamSYcb08bfc9-008f-4770-e053-2995a90a65ae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64646-420-03646460420033780 mL in 1 BOTTLE, DISPENSING3780 mlHistorical
64646-420-04646460420041250 mL in 1 BOTTLE, DISPENSING (64646-420-04) 1250 ml2021-09-100000-00-00NoNoCurrent
64646-420-1264646042012575 mL in 1 BOTTLE, PUMP (64646-420-12) 575 ml2021-09-100000-00-00NoNoCurrent
64646-420-7564646042075750 mL in 1 BOTTLE, DISPENSING750 mlHistorical