FDA.reportPublic FDA data

Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX

Product NDC
30805-016
11-digit product format
308050016
Labeler code
30805
Product ID
30805-016_313166e6-97b4-9adc-e063-6294a90ae685
Type
HUMAN OTC DRUG
Nonproprietary name
CHLOROXYLENOL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Buckeye International, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-15
Substance
CHLOROXYLENOL
Active strength
.3 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL.3 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0F32U78V2Q
Rxcui413261

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30805-016-02Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX1250 mL in 1 BAGSOLUTION12504
30805-016-07Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX550 mL in 1 BOTTLESOLUTION5504
30805-016-09Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX1000 mL in 1 BOTTLESOLUTION10004
30805-016-13Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX1000 mL in 1 BAGSOLUTION10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30805-016ALTRA ANTIMICROBIAL FOAMING HAND WASH WITH 0.3% PCMX (CHLOROXYLENOL) SOLUTION [BUCKEYE INTERNATIONAL, INC.]4Current NDC, Legacy NDC, 4 package rows20250327_a3ce509c-d919-0752-e053-2995a90a8ac4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSNa3ce509c-d919-0752-e053-2995a90a8ac44
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCDa3ce509c-d919-0752-e053-2995a90a8ac44
413261chloroxylenol 0.3 % Medicated Liquid SoapSYa3ce509c-d919-0752-e053-2995a90a8ac44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30805-016-02308050016021250 mL in 1 BAG (30805-016-02) 1250 ml2020-04-150000-00-00NoNoCurrent
30805-016-0730805001607550 mL in 1 BOTTLE (30805-016-07) 550 ml2020-04-150000-00-00NoNoCurrent
30805-016-09308050016091000 mL in 1 BOTTLE1000 mlHistorical
30805-016-13308050016131000 mL in 1 BAG (30805-016-13) 1000 ml2020-04-15NoNoHistorical