FDA.reportPublic FDA data

Smart Care APPLE HAND SANITIZER

Product NDC
70108-126
11-digit product format
701080126
Labeler code
70108
Product ID
70108-126_06623af3-576d-4648-8be8-4f20241ecf8d
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
2025-05-05
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Smart Care APPLE HAND SANITIZER
Listing expiration
2027-12-31

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
3a377d37-28c3-4cd6-8633-8b13464a28efAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-126-01Smart Care APPLE HAND SANITIZER40 mL in 1 BOTTLE, SPRAYSPRAY402
70108-126-01Smart Care APPLE HAND SANITIZER1 in 1 POUCHSPRAY12
70108-126-02Smart Care APPLE HAND SANITIZER44.4 mL in 1 BOTTLE, SPRAYSPRAY44.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-126SMART CARE APPLE HAND SANITIZER (ETHYL ALCOHOL) SPRAY [ASHTEL STUDIOS, INC.]1Current NDC, 3 package rows20250506_3a377d37-28c3-4cd6-8633-8b13464a28ef.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 APPLE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3a377d37-28c3-4cd6-8633-8b13464a28ef2026-04-17WarningsExact identifier
ndc (product): 70108-126

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041849ethanol 70 % Topical SprayPSN3a377d37-28c3-4cd6-8633-8b13464a28ef2
1041849ethanol 0.7 ML/ML Topical SpraySCD3a377d37-28c3-4cd6-8633-8b13464a28ef2
1041849ethanol 70 % Topical SpraySY3a377d37-28c3-4cd6-8633-8b13464a28ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70108-126-01701080126011 BOTTLE, SPRAY in 1 POUCH (70108-126-01) / 40 mL in 1 BOTTLE, SPRAY2025-05-05NoNoCurrent
70108-126-027010801260244.4 mL in 1 BOTTLE, SPRAY (70108-126-02) 44.4 ml2026-04-15NoNoCurrent