Estesol FH

Product NDC
11084-922
Requested package NDC
11084-922-87
11-digit product format
110840922
Labeler code
11084
Product ID
11084-922_caec88a7-d4e6-4abc-8d20-e494930bd5a0
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
SC Johnson Professional USA, Inc.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-06-01
Marketing end
2022-12-31
Substance
BENZALKONIUM CHLORIDE
Active strength
3 g/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage11084-92211084-922-87DDiscontinued by firm2026-10-16

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 INGREDIENTF5UM2KM3W7ESTESOL FH (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YESTESOL FH (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLESTESOL FH (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXESTESOL FH (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]1
COCAMIDOPROPYLAMINE OXIDEINACTIVE INGREDIENTM4SL82J7HKESTESOL FH (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]1
ETHANOLAMINEINACTIVE INGREDIENT5KV86114PTESTESOL FH (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16ESTESOL FH (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]1
PEG-6 COCAMIDEINACTIVE INGREDIENTYZ6NLA4O1EESTESOL FH (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RESTESOL FH (BENZALKONIUM CHLORIDE) LIQUID [DEB USA, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11084-922-87110840922872000 mL in 1 BOTTLE, PLASTIC (11084-922-87) 2000 ml2014-06-012022-12-31NoNoCurrent