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 FDA2026-10-15
excluded packagepackage64646-42064646-420-03IInactivated by FDA2026-10-15
excluded packagepackage64646-42064646-420-75IInactivated by FDA2026-10-15

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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
application number: M014
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
application number: M014
Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.15868798-28cd-4495-9baf-711e81ad8bdd2023-12-14WarningsExact identifier
application number: M014
Otix Ear wax Removal DropsCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.0e70ab09-9360-4ab6-a1fe-6f82af3925812023-12-14WarningsExact identifier
application number: M014
TopCare Earwax Removal DropsCARBAMIDE PEROXIDETopco Associates LLCc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2023-12-14WarningsExact identifier
application number: M014
DG Health Earwax Removal kitCARBAMIDE PEROXIDE 6.5%DOLLAR GENERAL CORPORATION4b6fc00f-72d7-4675-9881-b763f27c06e32023-12-07WarningsExact identifier
application number: M014
Ear Wax Removal Drops EquateCARBAMIDE PEROXIDE - 6.5%WALMART STORES INC33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d2023-12-04WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEProficient Rx LPa131447b-a5a0-45cd-a59c-a9f719275baa2023-12-01WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact 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