Pacific Blue Ultra

Product NDC
54622-572
Requested package NDC
54622-572-01
11-digit product format
546220572
Labeler code
54622
Product ID
54622-572_4a0379e2-98d8-b4e8-e063-6294a90a36bb
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Georgia-Pacific Consumer Products LP�
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-05-25
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Pacific Blue Ultra
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046593Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ea3f69f-e150-4beb-af1e-04ffc5a3b795Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54622-572-01Pacific Blue Ultra1200 mL in 1 BOTTLE, DISPENSINGSOAP120014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54622-572PACIFIC BLUE ULTRA (BENZALKONIUM CHLORIDE) SOAP [GEORGIA-PACIFIC CONSUMER PRODUCTS LP]12Current NDC, Legacy NDC, 1 package rows20240217_7ea3f69f-e150-4beb-af1e-04ffc5a3b795.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
Pacific Blue UltraBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LP7ea3f69f-e150-4beb-af1e-04ffc5a3b7952026-02-04Warnings, Adverse reactionsExact identifier
ndc (package): 54622-572-01
ndc (product): 54622-572
ndc11 (package): 54622057201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN7ea3f69f-e150-4beb-af1e-04ffc5a3b79514
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD7ea3f69f-e150-4beb-af1e-04ffc5a3b79514
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY7ea3f69f-e150-4beb-af1e-04ffc5a3b79514
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY7ea3f69f-e150-4beb-af1e-04ffc5a3b79514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54622-572-01546220572011200 mL in 1 BOTTLE, DISPENSING (54622-572-01) 1200 ml2016-05-250000-00-00NoNoCurrent