FDA.reportPublic FDA data

MediChoice OB Cleansing

Product NDC
39892-0306
Requested package NDC
39892-0306-1
11-digit product format
398920306
Labeler code
39892
Product ID
39892-0306_4d3acd22-e02b-0008-e063-6394a90aa987
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
O&M HALYARD, INC.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-29
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
MediChoice OB Cleansing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed38fb97-b67d-430b-8f6b-4fc78c16aeadAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39892-0306-1MediChoice OB Cleansing10 in 1 CASECLOTH107
39892-0306-1MediChoice OB Cleansing100 in 1 BOXCLOTH1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39892-0306MEDICHOICE OB CLEANSING (BENZALKONIUM CHLORIDE) CLOTH [OWENS & MINOR DISTRIBUTION, INC.]5Current NDC, Legacy NDC, 2 package rows20231210_ed38fb97-b67d-430b-8f6b-4fc78c16aead.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 90 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Extra-ThickISOPROPYL ALCOHOLMeijer Distribution Inc0b02643d-ea14-4877-ae9c-f0749d1b2d102025-01-03WarningsExact identifier
application number: M003
Premier ValueISOPROPYL ALCOHOLPharmacy Value Alliance, LLCd2baa47e-9673-7f23-e053-2a95a90adcb72025-01-03WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy88f761c1-cb50-4edc-9a54-43444378eff72025-01-03WarningsExact identifier
application number: M003
Sterile AlcoholISOPROPYL ALCOHOLChain Drug Marketing Association Inc55922632-3768-4450-9389-ba7d7d91f2c92025-01-03WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCASAD Company, Inc1e314157-c64e-492a-89ad-2b28831d551d2025-01-03WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.00002127-02bc-4c66-b0c3-ca29d8224afc2025-01-02WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d02e4d6-8751-b5bc-e063-6394a90a9d972025-01-01WarningsExact identifier
application number: M003
COVISIDE HAND SANITIZERISOPROPYL ALCOHOLCREAGEN INCa9f07fcd-4d5c-362c-e053-2a95a90a2e792024-12-30WarningsExact identifier
application number: M003
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact identifier
application number: M003
DE LA CRUZ GENTIAN VIOLETGENTIAN VIOLETDLC Laboratories, Inc.d7b4ca59-1bc3-4540-bc0a-2f4b7495a0a72024-12-30WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLR&C Imports LLC4e3fe418-d1d9-3024-e054-00144ff88e882024-12-27WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn CareHEXYLRESORCINOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2d81c9-5a9f-bb72-e063-6294a90aaf182024-12-26WarningsExact identifier
application number: M003
ABOVE INTIMATE LIQUIDSOAPABOVE INTIMATEBASTON INDUSTRIA DE AEROSSOIS LTDA02f37e55-72fb-532b-e063-6394a90ab0c32024-12-26WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMMY IMPORTS USA LLC2a23da19-aca0-6d86-e063-6394a90ad52e2024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.2a23ed29-20c3-ab51-e063-6394a90a13a22024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOLETHYL ALCOHOLMY IMPORTS USA LLC2a24bfc4-cf6e-29a4-e063-6394a90afa782024-12-25WarningsExact identifier
application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSINGBENZALKONIUMZhejiang Guoyao Jingyue Aerosol Co., Ltd.29ff1d68-06f7-e133-e063-6294a90a61542024-12-24WarningsExact identifier
application number: M003
MedBox Hand SanitizerALCOHOLHarpers Pharmacy, Inc.f66c6abe-161c-48fa-8736-0abf97c3799a2024-12-20WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE 10%Trifecta Pharmaceuticals USA LLCf80ccd8a-9b9b-bbf9-e053-6394a90ac8272024-12-20WarningsExact identifier
application number: M003
All Good Rose Geranium Hand SanitizerETHYL ALCOHOLElemental Herbs, Inc.f9b93df2-e28d-840e-e053-6294a90ae48a2024-12-20WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNed38fb97-b67d-430b-8f6b-4fc78c16aead7
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDed38fb97-b67d-430b-8f6b-4fc78c16aead7
1038558benzalkonium chloride 0.13 % Topical ClothSYed38fb97-b67d-430b-8f6b-4fc78c16aead7
1038558benzalkonium chloride 0.13 % Topical SwabSYed38fb97-b67d-430b-8f6b-4fc78c16aead7
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYed38fb97-b67d-430b-8f6b-4fc78c16aead7
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYed38fb97-b67d-430b-8f6b-4fc78c16aead7
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYed38fb97-b67d-430b-8f6b-4fc78c16aead7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39892-0306-13989203060110 BOX in 1 CASE (39892-0306-1) / 100 PACKET in 1 BOX / 1 PATCH in 1 PACKET / .75 g in 1 PATCH10 box2017-08-290000-00-00NoNoCurrent