Pacific Breeze Instant Hand Sanitizer Gel

Product NDC
65585-380
11-digit product format
655850380
Labeler code
65585
Product ID
65585-380_0c054670-1e49-d10b-e063-6294a90a7014
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Whisk Products, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-03
Substance
ALCOHOL
Active strength
600 mL/L
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
Pacific Breeze Instant Hand Sanitizer Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL600 mL/L

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
581658Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f574300-b05a-4f98-98fa-dd2177bb3d75Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-380-01Pacific Breeze Instant Hand Sanitizer Gel6 in 1 BOXGEL62
65585-380-01Pacific Breeze Instant Hand Sanitizer Gel1 L in 1 BAGGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-380PACIFIC BREEZE INSTANT HAND SANITIZER GEL (ALCOHOL) GEL [WHISK PRODUCTS, INC.]2Current NDC, 2 package rows20231209_3f574300-b05a-4f98-98fa-dd2177bb3d75.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
Pacific Breeze Instant Hand Sanitizer GelALCOHOLWhisk Products, Inc.3f574300-b05a-4f98-98fa-dd2177bb3d752023-12-08WarningsExact identifier
ndc (product): 65585-380

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581658ethanol 60 % Topical GelPSN3f574300-b05a-4f98-98fa-dd2177bb3d752
581658ethanol 0.6 ML/ML Topical GelSCD3f574300-b05a-4f98-98fa-dd2177bb3d752
581658ethanol 60 % Topical GelSY3f574300-b05a-4f98-98fa-dd2177bb3d752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65585-380-01655850380016 BAG in 1 BOX (65585-380-01) / 1 L in 1 BAG6 bag2023-03-03NoNoCurrent