FDA.reportPublic FDA data

DK12 Oatmeal Antibacterial and Moisturizing

Product NDC
62476-104
11-digit product format
624760104
Labeler code
62476
Product ID
62476-104_284c8398-d350-104e-e063-6394a90a9e65
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride 0.1%
Dosage form
SOAP
Route
TOPICAL
Labeler
Industria La Popular, S.A.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-01
Substance
BENZALKONIUM CHLORIDE
Active strength
.1 g/110g
NDC exclude flag
No
Listing certified through
2026-12-31
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
DK12 Oatmeal Antibacterial and Moisturizing
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.1 g/110g

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
1926450Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe16387b-1b16-1f41-e053-6294a90ae2c0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
07cba15c-4adc-1039-9ab9-45f5b7e84f4fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62476-104-15DK12 Oatmeal Antibacterial and Moisturizing140 g in 1 CELLO PACKSOAP1402
62476-104-42DK12 Oatmeal Antibacterial and Moisturizing420 g in 1 CELLO PACKSOAP4202
62476-104-84DK12 Oatmeal Antibacterial and Moisturizing840 g in 1 CELLO PACKSOAP8402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62476-104DK12 OATMEAL ANTIBACTERIAL AND MOISTURIZING (BENZALKONIUM CHLORIDE 0.1%) SOAP [INDUSTRIA LA POPULAR, S.A.]2Current NDC, 3 package rows20241204_fe16387b-1b16-1f41-e053-6294a90ae2c0.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 15 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70%ISOPROPYL ALCOHOLADUSA Distribution, LLCf340dd7e-6412-4621-a818-2592ca78d0f22026-06-23Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLADUSA Distribution, LLCd95a9736-345b-4b7e-9b24-23edb3cbf7e82026-06-23Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLADUSA Distribution, LLC7e066163-6629-43ad-b0b8-09c16fe94a0d2026-06-23Warnings, Adverse reactionsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.3ca0168d-8945-907a-e063-6294a90a9deb2026-06-23WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70ISOPROPYL ALCOHOLDelon Laboratories (1990) Ltd.fb481568-0c51-421f-9b73-adb4c84645aa2026-06-22WarningsExact identifier
application number: M003
Benzethonium chloride and Dyclonine hydrochlorideLIQUID BANDAGETarget Corporation326daa64-165a-cea6-e063-6294a90afbab2026-06-22WarningsExact identifier
application number: M003
MedlineISOPROPYL ALCOHOLMedline Industries, LP495076e9-3187-6bfa-e063-6394a90a01f52026-06-22WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.54def395-2f22-20a4-e063-6294a90a61962026-06-22WarningsExact identifier
application number: M003
Smart Care Hand Sanitizers 2pk Cherry Blossom and French VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e431cd-98fb-8346-e063-6294a90ad85e2026-06-22WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer-GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cea78b-515c-9562-e063-6394a90af1b42026-06-21WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer-MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cecbb4-5d85-dacf-e063-6294a90af8072026-06-21WarningsExact identifier
application number: M003
Smart Care Silicone Case for Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cef14d-dd2b-905f-e063-6294a90a66ba2026-06-21WarningsExact identifier
application number: M003
Smart Care Silicone Case for Hand Sanitizer MermicornoALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cedd57-03a9-e5e5-e063-6394a90a486b2026-06-21WarningsExact identifier
application number: M003
Smart Care Hand Sanitizers 2pk Fresh Rain and Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.54cf590a-2a74-d8fe-e063-6294a90a64382026-06-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pineapple SoleilETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48dfb925-add2-f9ef-e063-6394a90a3bab2026-06-17WarningsExact identifier
application number: M003
PVP Scrub SolutionPOVIDONE IODINEMcKesson Medical-Surgical Inc.49db333e-36e1-1965-e054-00144ff8d46c2026-06-17WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Holiday-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e55a6-7d63-2344-e063-6294a90ab4c02026-06-17WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Holiday- GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e76d4-e7ea-5cac-e063-6394a90a72942026-06-17WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547eaf43-ec33-b61a-e063-6294a90af6d92026-06-17WarningsExact identifier
application number: M003
Smart Care Holiday Hand Sanitizer-Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.547ef4f4-6f0b-23ea-e063-6294a90a75332026-06-17WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1926450benzalkonium chloride 0.1 % Medicated Bar SoapPSNfe16387b-1b16-1f41-e053-6294a90ae2c02
1926450benzalkonium chloride 0.001 MG/MG Medicated Bar SoapSCDfe16387b-1b16-1f41-e053-6294a90ae2c02
1926450benzalkonium chloride 0.1 % Medicated Bar SoapSYfe16387b-1b16-1f41-e053-6294a90ae2c02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62476-104-1562476010415140 g in 1 CELLO PACK (62476-104-15) 140 g2023-06-01NoNoCurrent
62476-104-4262476010442420 g in 1 CELLO PACK (62476-104-42) 420 g2023-06-01NoNoCurrent
62476-104-8462476010484840 g in 1 CELLO PACK (62476-104-84) 840 g2023-06-01NoNoCurrent