FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
70983-025
11-digit product format
709830025
Labeler code
70983
Product ID
70983-025_484f5b98-83f8-74b5-e063-6294a90a8019
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
SPRAY
Route
TOPICAL
Labeler
Saje Natural Business Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-01
Substance
ALCOHOL
Active strength
68 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
Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL68 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
1812262Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a70da1c6-4ca6-b801-e053-2a95a90ae1a5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-025-01Hand Sanitizer100 mL in 1 BOTTLE, SPRAYSPRAY1006
70983-025-02Hand Sanitizer200 mL in 1 BOTTLE, SPRAYSPRAY2006
70983-025-03Hand Sanitizer1000 mL in 1 BOTTLE, SPRAYSPRAY10006
70983-025-04Hand Sanitizer60 mL in 1 BOTTLE, SPRAYSPRAY606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-025HAND SANITIZER (ALCOHOL) SPRAY [SAJE NATURAL BUSINESS INC.]5Current NDC, Legacy NDC, 4 package rows20231101_a70da1c6-4ca6-b801-e053-2a95a90ae1a5.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
Hand SanitizerALCOHOLSaje Natural Business Inc.a70da1c6-4ca6-b801-e053-2a95a90ae1a52026-01-13WarningsExact identifier
ndc (product): 70983-025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812262ethanol 68 % Topical SprayPSNa70da1c6-4ca6-b801-e053-2a95a90ae1a56
1812262ethanol 0.68 ML/ML Topical SpraySCDa70da1c6-4ca6-b801-e053-2a95a90ae1a56
1812262ethanol 68 % Topical SpraySYa70da1c6-4ca6-b801-e053-2a95a90ae1a56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70983-025-0170983002501100 mL in 1 BOTTLE, SPRAY (70983-025-01) 100 ml2020-06-010000-00-00NoNoCurrent
70983-025-0270983002502200 mL in 1 BOTTLE, SPRAY (70983-025-02) 200 ml2020-06-010000-00-00NoNoCurrent
70983-025-03709830025031000 mL in 1 BOTTLE, SPRAY (70983-025-03) 1000 ml2020-06-260000-00-00NoNoCurrent
70983-025-047098300250460 mL in 1 BOTTLE, SPRAY (70983-025-04) 60 ml2021-03-020000-00-00NoNoCurrent