FDA.reportPublic FDA data

AQUARELLE

Product NDC
70697-804
Requested package NDC
70697-804-01
11-digit product format
706970804
Labeler code
70697
Product ID
70697-804_d57bdad7-4a59-f656-e053-2a95a90af7b2
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
INDELPA, S.A DE C.V
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-12-10
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70697-80470697-804-01IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70697-804-01AQUARELLE225 mL in 1 BOTTLELIQUID2253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70697-804AQUARELLE (BENZALKONIUM CHLORIDE) LIQUID [INDELPA, S.A DE C.V]3Legacy NDC, 1 package rows20240130_b62a0129-29de-3a27-e053-2a95a90a7f1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053188benzalkonium chloride 0.12 % Medicated Liquid SoapPSNb62a0129-29de-3a27-e053-2a95a90a7f1a3
1053188benzalkonium chloride 1.2 MG/ML Medicated Liquid SoapSCDb62a0129-29de-3a27-e053-2a95a90a7f1a3
1053188benzalkonium chloride 0.12 % Medicated Liquid SoapSYb62a0129-29de-3a27-e053-2a95a90a7f1a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70697-804-0170697080401225 mL in 1 BOTTLE (70697-804-01) 225 ml2020-12-110000-00-00NoNoCurrent