FDA.reportPublic FDA data

HCS Alcohol Prep Pad Medium

Product NDC
83506-018
11-digit product format
835060018
Labeler code
83506
Product ID
83506-018_ad3ae88b-db9c-4ab4-ae67-4fb19b91dfc0
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
SWAB
Route
TOPICAL
Labeler
Concordance Healthcare Solutions, LLC.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-06
Substance
ISOPROPYL 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
HCS Alcohol Prep Pad Medium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiND2M416302
Rxcui797544

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83506-018-022024-12-06C16284748780-11e7a6dab-1b78-a2ce-e063-dadaa90aadf7Drug Facts
83506-018-022024-07-30C16284748780-11e7a6dab-1b78-a2ce-e063-dadaa90aadf7Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83506-018-02HCS Alcohol Prep Pad Medium70 mL in 1 PACKETSWAB704
83506-018-02HCS Alcohol Prep Pad Medium200 in 1 CARTONSWAB2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83506-018HCS ALCOHOL PREP PAD MEDIUM (ISOPROPYL ALCOHOL) SWAB HCS ALCOHOL PREP PAD LARGE (ISOPROPYL ALCOHOL) SWAB [CONCORDANCE HEALTHCARE SOLUTIONS, LLC.]3Current NDC, 2 package rows20241208_3c4b14ca-3ff1-4a55-a239-31bfb5b3aaa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN3c4b14ca-3ff1-4a55-a239-31bfb5b3aaa54
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD3c4b14ca-3ff1-4a55-a239-31bfb5b3aaa54
797544isopropyl alcohol 70 % Medicated PadSY3c4b14ca-3ff1-4a55-a239-31bfb5b3aaa54
797544isopropyl alcohol 70 % Topical ClothSY3c4b14ca-3ff1-4a55-a239-31bfb5b3aaa54
797544isopropyl alcohol 70 % Topical SwabSY3c4b14ca-3ff1-4a55-a239-31bfb5b3aaa54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83506-018-0283506001802200 PACKET in 1 CARTON (83506-018-02) / 70 mL in 1 PACKET200 packet2023-06-06NoNoCurrent