FDA.reportPublic FDA data

MediChoice Barrier

Product NDC
39892-0951
11-digit product format
398920951
Labeler code
39892
Product ID
39892-0951_4d3ac95d-578a-033a-e063-6394a90ae5d5
Type
HUMAN OTC DRUG
Nonproprietary name
DIMETHICONE
Dosage form
CLOTH
Route
TOPICAL
Labeler
O&M HALYARD, INC.
Application
OKM016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-25
Substance
DIMETHICONE
Active strength
32 mg/g
Pharmacologic classes
Skin Barrier Activity [PE]
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 Barrier
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE32 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039149Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42477582-3ffa-4e51-a29b-86da07b14382Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39892-0951-1MediChoice Barrier8 in 1 PACKAGECLOTH83
39892-0951-1MediChoice Barrier20 g in 1 PATCHCLOTH203
39892-0951-2MediChoice Barrier30 in 1 PACKAGECLOTH303
39892-0951-2MediChoice Barrier8 in 1 CASECLOTH83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39892-0951MEDICHOICE BARRIER (DIMETHICONE) CLOTH [OWENS & MINOR DISTRIBUTION, INC.]1Current NDC, 4 package rows20240215_42477582-3ffa-4e51-a29b-86da07b14382.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MediChoice BarrierDIMETHICONEO&M HALYARD, INC.42477582-3ffa-4e51-a29b-86da07b143822026-03-17WarningsExact identifier
application number: OKM016
ndc (product): 39892-0951

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039149dimethicone 3.2 % Medicated PadPSN42477582-3ffa-4e51-a29b-86da07b143823
1039149dimethicone 32 MG/ML Medicated PadSCD42477582-3ffa-4e51-a29b-86da07b143823
1039149dimethicone 3.2 % Medicated PadSY42477582-3ffa-4e51-a29b-86da07b143823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
39892-0951-1398920951018 PATCH in 1 PACKAGE (39892-0951-1) / 20 g in 1 PATCH8 patch2024-01-25NoNoCurrent
39892-0951-2398920951028 PACKAGE in 1 CASE (39892-0951-2) / 30 PATCH in 1 PACKAGE / 20 g in 1 PATCH8 package2024-01-25NoNoCurrent