FDA.reportPublic FDA data

Mertodol Solution

Product NDC
65055-201
Requested package NDC
65055-201-02
11-digit product format
650550201
Labeler code
65055
Product ID
65055-201_3b7233fc-a570-29e4-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Laboratorios Jaloma, S.A. de C.V.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-08-24
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage65055-20165055-201-02DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7MERTODOL SOLUTION (BENZALKONIUM CHLORIDE) LIQUID [LABORATORIOS JALOMA, S.A. DE C.V.]2
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YMERTODOL SOLUTION (BENZALKONIUM CHLORIDE) LIQUID [LABORATORIOS JALOMA, S.A. DE C.V.]2
ACETONEINACTIVE INGREDIENT1364PS73AFMERTODOL SOLUTION (BENZALKONIUM CHLORIDE) LIQUID [LABORATORIOS JALOMA, S.A. DE C.V.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMERTODOL SOLUTION (BENZALKONIUM CHLORIDE) LIQUID [LABORATORIOS JALOMA, S.A. DE C.V.]2
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RTMERTODOL SOLUTION (BENZALKONIUM CHLORIDE) LIQUID [LABORATORIOS JALOMA, S.A. DE C.V.]2
WATERINACTIVE INGREDIENT059QF0KO0RMERTODOL SOLUTION (BENZALKONIUM CHLORIDE) LIQUID [LABORATORIOS JALOMA, S.A. DE C.V.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65055-201MERTODOL SOLUTION (BENZALKONIUM CHLORIDE) LIQUID [LABORATORIOS JALOMA, S.A. DE C.V.]7Legacy NDC20231110_81a41ee8-58c0-4df8-9af1-ab6167736699.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65055-201-026505502010240 mL in 1 BOTTLE, PLASTIC (65055-201-02) 40 ml2016-08-240000-00-00NoNoCurrent