FDA.reportPublic FDA data

Smart Care WATERMELON HAND SANITIZER

Product NDC
70108-097
11-digit product format
701080097
Labeler code
70108
Product ID
70108-097_f94b4730-97a2-4214-9990-61658d48ce7e
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Ashtel Studios Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
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
Smart Care WATERMELON HAND SANITIZER
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
dc2c772b-4bd4-4a5f-b89d-ad2ca36574e0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-097-01Smart Care WATERMELON HAND SANITIZER40 mL in 1 BOTTLE, SPRAYSPRAY401
70108-097-01Smart Care WATERMELON HAND SANITIZER1 in 1 POUCHSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-097SMART CARE WATERMELON HAND SANITIZER (ETHYL ALCOHOL) SPRAY [ASHTEL STUDIOS INC.]1Current NDC, 2 package rows20240901_dc2c772b-4bd4-4a5f-b89d-ad2ca36574e0.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
Smart Care WATERMELON HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.dc2c772b-4bd4-4a5f-b89d-ad2ca36574e02024-08-07WarningsExact identifier
ndc (product): 70108-097

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041849ethanol 70 % Topical SprayPSNdc2c772b-4bd4-4a5f-b89d-ad2ca36574e01
1041849ethanol 0.7 ML/ML Topical SpraySCDdc2c772b-4bd4-4a5f-b89d-ad2ca36574e01
1041849ethanol 70 % Topical SpraySYdc2c772b-4bd4-4a5f-b89d-ad2ca36574e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70108-097-01701080097011 BOTTLE, SPRAY in 1 POUCH (70108-097-01) / 40 mL in 1 BOTTLE, SPRAY2024-09-01NoNoCurrent