FDA.reportPublic FDA data

safeHands

Product NDC
60867-101
11-digit product format
608670101
Labeler code
60867
Product ID
60867-101_c6c02448-eb63-4f65-9200-4673d6bf62b8
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
safeHands LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-09-27
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60867-101IInactivated by FDA2026-07-31
excluded packagepackage60867-10160867-101-02IInactivated by FDA2026-07-31
excluded packagepackage60867-10160867-101-07IInactivated by FDA2026-07-31
excluded packagepackage60867-10160867-101-18IInactivated by FDA2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60867-101-022020-01-31C16284748780-19d75b9d0-cb41-f424-e053-dadaa90a57ced147513b-e05d-46fd-83f2-0f329bf7aa54
60867-101-072020-01-31C16284748780-19d75b9d0-cb41-f424-e053-dadaa90a57ced147513b-e05d-46fd-83f2-0f329bf7aa54
60867-101-182020-01-31C16284748780-19d75b9d0-cb41-f424-e053-dadaa90a57ced147513b-e05d-46fd-83f2-0f329bf7aa54

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60867-101-02safeHands52 mL in 1 BOTTLELIQUID521
60867-101-07safeHands208 mL in 1 BOTTLELIQUID2081
60867-101-18safeHands532 mL in 1 BOTTLELIQUID5321

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7SAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YSAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]1
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEINACTIVE INGREDIENTH2KVQ74JM4SAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MSAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHSAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]1
TRIETHYLENE GLYCOLINACTIVE INGREDIENT3P5SU53360SAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RSAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60867-101SAFEHANDS (BENZALKONIUM CHLORIDE) LIQUID [SAFEHANDS LLC]1Legacy NDC, 3 package rows20140929_d147513b-e05d-46fd-83f2-0f329bf7aa54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSNd147513b-e05d-46fd-83f2-0f329bf7aa541
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCDd147513b-e05d-46fd-83f2-0f329bf7aa541
1049254benzalkonium chloride 0.13 % Topical SolutionSYd147513b-e05d-46fd-83f2-0f329bf7aa541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
60867-101-026086701010252 mL in 1 BOTTLE52 mlHistorical
60867-101-0760867010107208 mL in 1 BOTTLE208 mlHistorical
60867-101-1860867010118532 mL in 1 BOTTLE532 mlHistorical