FDA.reportPublic FDA data

Spectrum 62% Hand Sanitizer

Product NDC
53329-214
Requested package NDC
53329-214-84
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

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
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

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 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): 53329-214-84
ndc (product): 53329-214
ndc11 (package): 53329021484

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
53329-214-84533290214841000 mL in 1 BAG (53329-214-84) 1000 ml2018-04-090000-00-00NoNoCurrent