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 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
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
98450cde-bfc9-4868-be45-6459e1c5e11fAvailable on FDA.report

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

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
LEMONBELLA Lavender Hand SanitizerALCOHOLLemonbella LLC98450cde-bfc9-4868-be45-6459e1c5e11f2023-11-11WarningsExact identifier
ndc (product): 81319-112

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