Hand wash

Product NDC
55315-403
Requested package NDC
55315-403-49
11-digit product format
553150403
Labeler code
55315
Product ID
55315-403_44830f6e-2802-4a3f-bb2a-a7a02ea1a54d
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Fred's Inc
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-01-23
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
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 packagepackage55315-40355315-403-49DDiscontinued 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 · 10 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…

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 INGREDIENTF5UM2KM3W7HAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBPHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
LAURAMIDOPROPYLAMINE OXIDEINACTIVE INGREDIENTI6KX160QTVHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
MYRISTAMIDOPROPYLAMINE OXIDEINACTIVE INGREDIENT3HSF539C9THAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
PEG-120 METHYL GLUCOSE DIOLEATEINACTIVE INGREDIENTYM0K64F20VHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3THAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21JHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1
WATERINACTIVE INGREDIENT059QF0KO0RHAND WASH (BENZALKONIUM CHLORIDE) SOAP [FRED'S INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55315-403-4955315040349443 mL in 1 BOTTLE, PLASTIC (55315-403-49) 443 ml2015-01-230000-00-00NoNoCurrent