FDA.reportPublic FDA data

Hand Sanitizer Isopropyl Alcohol Antiseptic 75

Product NDC
76458-400
Requested package NDC
76458-400-08
11-digit product format
764580400
Labeler code
76458
Product ID
76458-400_0c8f6687-e666-c08c-e063-6394a90a3921
Type
HUMAN OTC DRUG
Nonproprietary name
ISOPROPYL ALCOHOL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Circadia by Dr Pugliese, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-06
Substance
ISOPROPYL ALCOHOL
Active strength
.75 mL/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hand Sanitizer Isopropyl Alcohol Antiseptic 75
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL.75 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039900Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6f4b6ccc-209d-4782-8743-322cc683e877Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76458-400-08Hand Sanitizer Isopropyl Alcohol Antiseptic 75236 mL in 1 BOTTLESOLUTION2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76458-400HAND SANITIZER ISOPROPYL ALCOHOL ANTISEPTIC 75 (ISOPROPYL ALCOHOL) SOLUTION [CIRCADIA BY DR PUGLIESE, INC.]2Current NDC, Legacy NDC, 1 package rows20231216_6f4b6ccc-209d-4782-8743-322cc683e877.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
Hand Sanitizer Isopropyl Alcohol Antiseptic 75ISOPROPYL ALCOHOLCircadia by Dr Pugliese, Inc.6f4b6ccc-209d-4782-8743-322cc683e8772023-12-15WarningsExact identifier
ndc (package): 76458-400-08
ndc (product): 76458-400
ndc11 (package): 76458040008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN6f4b6ccc-209d-4782-8743-322cc683e8772
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD6f4b6ccc-209d-4782-8743-322cc683e8772
1039900isopropyl alcohol 75 % Topical SolutionSY6f4b6ccc-209d-4782-8743-322cc683e8772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76458-400-0876458040008236 mL in 1 BOTTLE (76458-400-08) 236 ml2020-04-060000-00-00NoNoCurrent