FDA.reportPublic FDA data

B-Pure Moisturizing Hand Sanitizer Sugar Pistachio Scented

Product NDC
80684-184
11-digit product format
806840184
Labeler code
80684
Product ID
80684-184_46272de0-3c63-711b-e063-6394a90ad722
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Fourstar Group USA, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-03
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage80684-18480684-184-00DDiscontinued by firm2026-10-05

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
B-Pure Moisturizing Hand Sanitizer Sugar Pistachio 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
b80c402e-ecef-42fe-8cf5-7aa26254a3feAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-184-00B-Pure Moisturizing Hand Sanitizer Sugar Pistachio Scented34 mL in 1 BOTTLELIQUID342
80684-184-01B-Pure Moisturizing Hand Sanitizer Sugar Pistachio Scented34 mL in 1 BOTTLELIQUID342

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 Moisturizing Hand Sanitizer Sugar Pistachio ScentedALCOHOLFourstar Group USA, Inc.b80c402e-ecef-42fe-8cf5-7aa26254a3fe2025-12-17WarningsExact identifier
ndc (product): 80684-184

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041849ethanol 70 % Topical SprayPSNb80c402e-ecef-42fe-8cf5-7aa26254a3fe2
1041849ethanol 0.7 ML/ML Topical SpraySCDb80c402e-ecef-42fe-8cf5-7aa26254a3fe2
1041849ethanol 70 % Topical SpraySYb80c402e-ecef-42fe-8cf5-7aa26254a3fe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80684-184-008068401840034 mL in 1 BOTTLE34 mlHistorical
80684-184-018068401840134 mL in 1 BOTTLE (80684-184-01) 34 ml2025-11-03NoNoCurrent