FDA.reportPublic FDA data

b.pure Hand Sanitizer Green Apple Scented

Product NDC
80684-125
11-digit product format
806840125
Labeler code
80684
Product ID
80684-125_1d0fdff4-f10a-8462-e063-6294a90aa1f7
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
FOURSTAR GROUP USA, INC.
Application
M505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-26
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
b.pure Hand Sanitizer Green Apple Scented
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 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
1041849Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c870d8f-c298-4469-b6d1-f318f6adfd26Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-125-00b.pure Hand Sanitizer Green Apple Scented10 mL in 1 BOTTLELIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-125B.PURE HAND SANITIZER GREEN APPLE SCENTED (ALCOHOL) LIQUID [FOURSTAR GROUP USA, INC.]1Current NDC, 1 package rows20240726_7c870d8f-c298-4469-b6d1-f318f6adfd26.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
b.pure Hand Sanitizer Green Apple ScentedALCOHOLFOURSTAR GROUP USA, INC.7c870d8f-c298-4469-b6d1-f318f6adfd262024-07-12WarningsExact identifier
ndc (product): 80684-125

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041849ethanol 70 % Topical SprayPSN7c870d8f-c298-4469-b6d1-f318f6adfd261
1041849ethanol 0.7 ML/ML Topical SpraySCD7c870d8f-c298-4469-b6d1-f318f6adfd261
1041849ethanol 70 % Topical SpraySY7c870d8f-c298-4469-b6d1-f318f6adfd261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80684-125-008068401250010 mL in 1 BOTTLE (80684-125-00) 10 ml2024-07-26NoNoCurrent