B Pure Hand Sanitizer Tropical Burst Scented

Product NDC: 80684-194
Requested package NDC: 80684-194-01
11-digit product format: 806840194
Labeler code: 80684
Product ID: 80684-194_459a5f0a-1e0d-b500-e063-6394a90a4bf7
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: 2025-11-17
Substance: ALCOHOL
Active strength: 70 mL/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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: B Pure Hand Sanitizer Tropical Burst Scented
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	70 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1041849	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
90c59897-ae56-4c5f-a0da-ced827e63eb0	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80684-194-01	B Pure Hand Sanitizer Tropical Burst Scented	10 mL in 1 BOTTLE	LIQUID	10		1

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
B Pure Hand Sanitizer Tropical Burst Scented	ALCOHOL	Fourstar Group USA, Inc.	90c59897-ae56-4c5f-a0da-ced827e63eb0	2025-12-10	Warnings	Exact identifier ndc (package): 80684-194-01 ndc (product): 80684-194 ndc11 (package): 80684019401

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1041849	ethanol 70 % Topical Spray	PSN	90c59897-ae56-4c5f-a0da-ced827e63eb0	1
1041849	ethanol 0.7 ML/ML Topical Spray	SCD	90c59897-ae56-4c5f-a0da-ced827e63eb0	1
1041849	ethanol 70 % Topical Spray	SY	90c59897-ae56-4c5f-a0da-ced827e63eb0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80684-194-01	80684019401	10 mL in 1 BOTTLE (80684-194-01)	10 ml	2025-11-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
B-Pure Hand Sanitizer Spray Tropical Burst Scented	Fourstar Group USA, Inc.	2025-12-10	HUMAN OTC DRUG LABEL	1