FDA.reportPublic FDA data

Spectrum 62% Hand Sanitizer

Product NDC
53329-214
Requested package NDC
53329-214-13
11-digit product format
533290214
Labeler code
53329
Product ID
53329-214_4a8e3675-99a2-b6e6-e063-6394a90a7d48
Type
HUMAN OTC DRUG
Nonproprietary name
ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Medline Industries, LP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-09
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53329-21453329-214-13DDiscontinued by firm2026-08-03

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spectrum 62% Hand SanitizerETHYL ALCOHOLMedline Industries, LP6971b7de-039d-292f-e053-2a91aa0a26b22026-02-11WarningsExact identifier
ndc (package): 53329-214-13
ndc (product): 53329-214
ndc11 (package): 53329021413

Additional Listing Data#

Finished product
Yes
Brand name base
Spectrum 62% Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 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
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6971b7de-039d-292f-e053-2a91aa0a26b2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-214-13Spectrum 62% Hand Sanitizer59.147 mL in 1 BOTTLEGEL59.1479
53329-214-70Spectrum 62% Hand Sanitizer443.6 mL in 1 BOTTLEGEL443.69
53329-214-84Spectrum 62% Hand Sanitizer1000 mL in 1 BAGGEL10009
53329-214-85Spectrum 62% Hand Sanitizer354 mL in 1 BOTTLEGEL3549

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-214SPECTRUM 62% HAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, LP]8Current NDC, Legacy NDC, 4 package rows20240531_6971b7de-039d-292f-e053-2a91aa0a26b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN6971b7de-039d-292f-e053-2a91aa0a26b29
581660ethanol 0.62 ML/ML Topical GelSCD6971b7de-039d-292f-e053-2a91aa0a26b29
581660ethanol 62 % Topical GelSY6971b7de-039d-292f-e053-2a91aa0a26b29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-214-135332902141359.147 mL in 1 BOTTLE (53329-214-13) 59.147 ml2018-04-090000-00-00NoNoCurrent