RoyaLab Germ Away Antibacterial

Product NDC
82077-701
11-digit product format
820770701
Labeler code
82077
Product ID
82077-701_3bcc21fe-9a5d-9588-e063-6394a90af6f2
Type
HUMAN OTC DRUG
Nonproprietary name
PMCX, Handwashing and Hand Soap
Dosage form
SOAP
Route
TOPICAL
Labeler
Royal Papers, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-30
Substance
CHLOROXYLENOL
Active strength
1 g/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RoyaLab Germ Away Antibacterial
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL1 g/L

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
1941461Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c5ffebf0-73a2-eba8-e053-2a95a90a43d9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82077-701-41RoyaLab Germ Away Antibacterial3.78 L in 1 BOTTLE, PLASTICSOAP3.786

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82077-701ROYALAB GERM AWAY ANTIBACTERIAL (PMCX, HANDWASHING AND HAND SOAP) SOAP [ROYAL PAPERS, INC.]4Current NDC, Legacy NDC, 1 package rows20240910_c5ffebf0-73a2-eba8-e053-2a95a90a43d9.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
RoyaLab Germ Away AntibacterialPMCX, HANDWASHING AND HAND SOAPRoyal Papers, Inc.c5ffebf0-73a2-eba8-e053-2a95a90a43d92025-08-07WarningsExact identifier
ndc (product): 82077-701

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1941461chloroxylenol 0.1 % Medicated Liquid SoapPSNc5ffebf0-73a2-eba8-e053-2a95a90a43d96
1941461chloroxylenol 1 MG/ML Medicated Liquid SoapSCDc5ffebf0-73a2-eba8-e053-2a95a90a43d96
1941461chloroxylenol 0.1 % Medicated Liquid SoapSYc5ffebf0-73a2-eba8-e053-2a95a90a43d96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82077-701-41820770701413.78 L in 1 BOTTLE, PLASTIC (82077-701-41) 3.78 l2021-06-300000-00-00NoNoCurrent