FDA.reportPublic FDA data

LEMONBELLA Lavender Hand Sanitizer

Product NDC
81319-112
11-digit product format
813190112
Labeler code
81319
Product ID
81319-112_09e28a29-b7c5-10d0-e063-6394a90a7861
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Lemonbella LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-20
Substance
ALCOHOL
Active strength
.7 mL/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LEMONBELLA Lavender Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL.7 mL/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81319-112-01LEMONBELLA Lavender Hand Sanitizer100.5 mL in 1 BOTTLEGEL100.52
81319-112-02LEMONBELLA Lavender Hand Sanitizer2 mL in 1 PACKETGEL22
81319-112-03LEMONBELLA Lavender Hand Sanitizer2 mL in 1 PACKETGEL22
81319-112-03LEMONBELLA Lavender Hand Sanitizer30 in 1 BOXGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81319-112LEMONBELLA LAVENDER HAND SANITIZER (ALCOHOL) GEL [LEMONBELLA LLC]2Current NDC, Legacy NDC, 4 package rows20231112_98450cde-bfc9-4868-be45-6459e1c5e11f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN98450cde-bfc9-4868-be45-6459e1c5e11f2
581662ethanol 0.7 ML/ML Topical GelSCD98450cde-bfc9-4868-be45-6459e1c5e11f2
581662ethanol 70 % Topical GelSY98450cde-bfc9-4868-be45-6459e1c5e11f2
581662ethyl alcohol 70 % Topical GelSY98450cde-bfc9-4868-be45-6459e1c5e11f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81319-112-0181319011201100.5 mL in 1 BOTTLE (81319-112-01) 100.5 ml2020-12-200000-00-00NoNoCurrent
81319-112-02813190112022 mL in 1 PACKET (81319-112-02) 2 ml2020-12-200000-00-00NoNoCurrent
81319-112-038131901120330 PACKET in 1 BOX (81319-112-03) / 2 mL in 1 PACKET30 packet2020-12-200000-00-00NoNoCurrent