FDA.reportPublic FDA data

Xtra Antibacterial Hand Juicy Orange

Product NDC
51628-0033
11-digit product format
516280033
Labeler code
51628
Product ID
51628-0033_4b80329b-80a2-f8a9-e063-6394a90a8a41
Type
HUMAN OTC DRUG
Nonproprietary name
CHLOROXYLENOL
Dosage form
GEL
Route
TOPICAL
Labeler
MY IMPORTS USA, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-01
Substance
CHLOROXYLENOL
Active strength
3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Xtra Antibacterial Hand Juicy Orange
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0F32U78V2QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
413261Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcf89d68-571d-4d10-9c01-1a5cc743c918Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51628-0033-0Xtra Antibacterial Hand Juicy Orange709 mL in 1 BOTTLEGEL7092

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51628-0033XTRA ANTIBACTERIAL HAND JUICY ORANGE (CHLOROXYLENOL) GEL [MY IMPORTS USA, LLC]1Current NDC, 1 package rows20231222_fcf89d68-571d-4d10-9c01-1a5cc743c918.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
Xtra Antibacterial Hand Juicy OrangeCHLOROXYLENOLMY IMPORTS USA, LLCfcf89d68-571d-4d10-9c01-1a5cc743c9182026-02-23WarningsExact identifier
ndc (product): 51628-0033

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSNfcf89d68-571d-4d10-9c01-1a5cc743c9182
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCDfcf89d68-571d-4d10-9c01-1a5cc743c9182
413261chloroxylenol 0.3 % Medicated Liquid SoapSYfcf89d68-571d-4d10-9c01-1a5cc743c9182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51628-0033-051628003300709 mL in 1 BOTTLE (51628-0033-0) 709 ml2023-12-01NoNoCurrent