FDA.reportPublic FDA data

MediChoice Barrier

Product NDC
39892-0950
Requested package NDC
39892-0950-2
11-digit product format
398920950
Labeler code
39892
Product ID
39892-0950_4d3ae6cf-32b8-1875-e063-6394a90ae4c1
Type
HUMAN OTC DRUG
Nonproprietary name
DIMETHICONE
Dosage form
CLOTH
Route
TOPICAL
Labeler
O&M HALYARD, INC.
Application
M016
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
115c2a2f-d68a-316a-e063-6394a90a2716Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39892-0950-1MediChoice Barrier20 g in 1 PATCHCLOTH203
39892-0950-1MediChoice Barrier3 in 1 PACKAGECLOTH33
39892-0950-2MediChoice Barrier216 in 1 PACKAGECLOTH2163
39892-0950-2MediChoice Barrier72 in 1 CASECLOTH723

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39892-0950MEDICHOICE BARRIER (DIMETHICONE) CLOTH [OWENS & MINOR DISTRIBUTION, INC.]1Current NDC, 4 package rows20240215_115c2a2f-d68a-316a-e063-6394a90a2716.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 61 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Supreme Classic CherryWHITE PETROLATUMHaleon US Holdings LLC84d8cc38-83e3-49be-b180-d01820525b602024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC9cd13fbb-887f-46a8-9f0b-4450ad3e07b72024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Peachy KeenZINC OXIDEHaleon US Holdings LLCef206fe7-2659-41dc-b117-380af704999b2024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Pretty in PinkZINC OXIDEHaleon US Holdings LLCe686ce23-57bc-4026-be62-d46d90ded4422024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Very BerryZINC OXIDEHaleon US Holdings LLC59023150-65ef-4427-9045-0e64b100cbab2024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer Cool MintAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLC33497c07-ad6e-4c50-bc23-a55725b2eae12024-03-21WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCde250ae9-6e4a-46ca-bcc9-5bb07dbb70c52024-03-21WarningsExact identifier
application number: M016
ChapStick Classic StrawberryWHITE PETROLATUMHaleon US Holdings LLC3a279496-74c5-4ab1-ba69-06ad4a4f67cf2024-03-21WarningsExact identifier
application number: M016
Chapstick Moisturizer Cool MintAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLCc1120c7a-1fa8-45a4-8bcf-35d9cc9f2c742024-03-21WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Sore Relief KitALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions523b6598-8039-4116-b0f8-ba31d7d6ea9d2024-03-20WarningsExact identifier
application number: M016
ChapStick Classic CherryWHITE PETROLATUMHaleon US Holdings LLCdb041b1b-084a-4283-b6ba-4d4bcdc220b32024-03-19WarningsExact identifier
application number: M016
ChapStick Classic OriginalWHITE PETROLATUMHaleon US Holdings LLC42fe0f4a-efb7-4e70-a359-db7dc2ac99052024-03-19WarningsExact identifier
application number: M016
ChapStick Classic SpearmintWHITE PETROLATUMHaleon US Holdings LLC74354d8e-c265-4a27-9715-1a4c157ad8902024-03-19WarningsExact identifier
application number: M016
Cetaphil HealingPETROLATUMGalderma Laboratories, L.P.e996db17-bd4d-4b06-bb9a-983dbdec80222024-03-13WarningsExact identifier
application number: M016
Diaper Rash Cream 2ozZINC OXIDERejoice International Corp.130a06a7-3360-afed-e063-6294a90ac19f2024-03-06WarningsExact identifier
application number: M016
mama bear DIAPER RASH Skin ProtectantLANOLIN AND PETROLATUMAMAZON.COM SERVICES LLCcda9ca47-b668-4a65-908d-80b9a6515bd72024-03-06WarningsExact identifier
application number: M016
Dermachange ScarALLANTOINPrivate Label Beauty and Wellness12eed473-10d6-49c8-e063-6394a90afb632024-03-05WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum Jelly Cocoa Butter EnrichedPETROLEUMRejoice International580d76ee-ea89-426e-bd25-7a58481e97952024-02-28WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum Jelly Vitamin E enrichedPETROLATUMRejoice International2c382a50-93d2-4d28-b7a4-1702b20b71392024-02-28WarningsExact identifier
application number: M016
XtraCare Foaming Facial CleanserTRICLOSANRejoice International313fcd4a-8641-417e-bf0b-02359ad815fe2024-02-28WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039149dimethicone 3.2 % Medicated PadPSN115c2a2f-d68a-316a-e063-6394a90a27163
1039149dimethicone 32 MG/ML Medicated PadSCD115c2a2f-d68a-316a-e063-6394a90a27163
1039149dimethicone 3.2 % Medicated PadSY115c2a2f-d68a-316a-e063-6394a90a27163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
39892-0950-23989209500272 PACKAGE in 1 CASE (39892-0950-2) / 216 PATCH in 1 PACKAGE / 20 g in 1 PATCH72 package2024-01-25NoNoCurrent