FDA.reportPublic FDA data

ZEP PEAR AB HS

Product NDC
66949-393
11-digit product format
669490393
Labeler code
66949
Product ID
66949-393_46df36fa-7dc4-2e3b-e063-6294a90ab8cf
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Zep Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-03
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 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
ZEP PEAR AB HS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

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
5bc1cc32-5d18-00a8-e053-2991aa0a0c81Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66949-393-01ZEP PEAR AB HS6000 mL in 1 CASELIQUID60009
66949-393-11ZEP PEAR AB HS6000 mL in 1 CASELIQUID60009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66949-393ZEP PEAR AB HS (BENZALKONIUM CHLORIDE) LIQUID [ZEP INC.]8Current NDC, Legacy NDC, 2 package rows20241120_5bc1cc32-5d18-00a8-e053-2991aa0a0c81.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
ZEP PEAR AB HSBENZALKONIUM CHLORIDEZep Inc.5bc1cc32-5d18-00a8-e053-2991aa0a0c812025-12-26WarningsExact identifier
ndc (product): 66949-393

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN5bc1cc32-5d18-00a8-e053-2991aa0a0c819
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD5bc1cc32-5d18-00a8-e053-2991aa0a0c819
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY5bc1cc32-5d18-00a8-e053-2991aa0a0c819
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY5bc1cc32-5d18-00a8-e053-2991aa0a0c819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66949-393-01669490393016000 mL in 1 CASE (66949-393-01) 6000 ml2017-03-030000-00-00NoNoCurrent
66949-393-11669490393116000 mL in 1 CASE (66949-393-11) 6000 ml2017-03-030000-00-00NoNoCurrent