FDA.reportPublic FDA data

Freds Antiseptic Wash

Product NDC
67868-054
11-digit product format
678680054
Labeler code
67868
Product ID
67868-054_bfa1413c-d38a-4d3b-b129-9eb5e323dec0
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pharma Pac, LLC
Application
part333A
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-07-08
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
1 mg/mL; mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67868-054-392019-11-13C16284748780-197449f38-c218-f6ea-e053-dbdaa90aa703drug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67868-054-39Freds Antiseptic Wash177 mL in 1 BOTTLE, DISPENSINGLIQUID1772

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7FREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]2
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AFREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]2
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YFREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]2
LIDOCAINEACTIVE MOIETY98PI200987FREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XFREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]2
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGAFREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]2
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGFREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RFREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67868-054FREDS ANTISEPTIC WASH (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [PHARMA PAC, LLC]2Legacy NDC, 1 package rows20120501_66bb7522-e702-4f74-8b7a-9ac2e1e3650f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012081benzalkonium chloride 0.13 % / lidocaine HCl 2 % Topical SolutionPSN66bb7522-e702-4f74-8b7a-9ac2e1e3650f2
1012081benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 20 MG/ML Topical SolutionSCD66bb7522-e702-4f74-8b7a-9ac2e1e3650f2
1012081benzalkonium chloride 0.13 % / lidocaine hydrochloride 2 % Topical SolutionSY66bb7522-e702-4f74-8b7a-9ac2e1e3650f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67868-054-3967868005439177 mL in 1 BOTTLE, DISPENSING177 mlHistorical