FDA.reportPublic FDA data

AQUARELLE

Product NDC
70697-805
Requested package NDC
70697-805-06
11-digit product format
706970805
Labeler code
70697
Product ID
70697-805_f1f19ceb-b1a5-6624-e053-2995a90ae432
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
INDELPA, S.A DE C.V
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-10-01
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 mg/100mg
NDC exclude flag
No
Listing certified through
2024-12-31
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 packagepackage70697-80570697-805-06IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
70697-805-01b79fc794-5db3-a017-e053-2995a90a0b1d
70697-805-02b79fc794-5db3-a017-e053-2995a90a0b1d
70697-805-03b79fc794-5db3-a017-e053-2995a90a0b1d
70697-805-04b79fc794-5db3-a017-e053-2995a90a0b1d
70697-805-05b79fc794-5db3-a017-e053-2995a90a0b1d
70697-805-06b79fc794-5db3-a017-e053-2995a90a0b1d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70697-805-01AQUARELLE15 in 1 PACKAGECLOTH154
70697-805-01AQUARELLE30 in 1 CASECLOTH304
70697-805-02AQUARELLE0.375 mg in 1 POUCHCLOTH0.3754
70697-805-02AQUARELLE24 in 1 CASECLOTH244
70697-805-03AQUARELLE0.375 mg in 1 POUCHCLOTH0.3754
70697-805-03AQUARELLE12 in 1 CASECLOTH124
70697-805-04AQUARELLE0.375 mg in 1 POUCHCLOTH0.3754
70697-805-04AQUARELLE24 in 1 CASECLOTH244
70697-805-05AQUARELLE16 in 1 BOXCLOTH164
70697-805-05AQUARELLE1 in 1 PACKAGECLOTH14
70697-805-06AQUARELLE24 in 1 CASECLOTH244
70697-805-06AQUARELLE0.375 mg in 1 POUCHCLOTH0.3754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70697-805AQUARELLE (BENZALKONIUM CHLORIDE) CLOTH [INDELPA, S.A DE C.V]4Legacy NDC, 12 package rows20230111_b79fc794-5db3-a017-e053-2995a90a0b1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2276303benzalkonium Cl 0.125 % Medicated PadPSNb79fc794-5db3-a017-e053-2995a90a0b1d4
2276303benzalkonium chloride 1.25 MG/ML Medicated PadSCDb79fc794-5db3-a017-e053-2995a90a0b1d4
2276303benzalkonium chloride 0.125 % Medicated WipeSYb79fc794-5db3-a017-e053-2995a90a0b1d4
2276303benzalkonium chloride 0.125 % Topical ClothSYb79fc794-5db3-a017-e053-2995a90a0b1d4
2276303benzalkonium chloride 0.125 % Topical SwabSYb79fc794-5db3-a017-e053-2995a90a0b1d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70697-805-067069708050624 POUCH in 1 CASE (70697-805-06) > .375 mg in 1 POUCH24 pouch2021-11-010000-00-00NoNoCurrent