Dimethicone 1 Skin Protectant

Product NDC
52000-417
11-digit product format
520000417
Labeler code
52000
Product ID
52000-417_f426c186-d0fc-4e9f-b3b5-42d6ae20e77a
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
LOTION
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-17
Substance
DIMETHICONE, UNSPECIFIED
Active strength
1 g/100mL
Pharmacologic classes
Skin Barrier Activity [PE]
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
Dimethicone 1 Skin Protectant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED1 g/100mL

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
199680Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c5b96b9-24d6-4223-a63d-fe83d7c02368Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-417-12Dimethicone 1 Skin Protectant355 mL in 1 BOTTLE, PUMPLOTION3552

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-417DIMETHICONE 1 SKIN PROTECTANT (DIMETHICONE) LOTION [UNIVERSAL DISTRIBUTION CENTER LLC]1Current NDC, 1 package rows20240524_2c5b96b9-24d6-4223-a63d-fe83d7c02368.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 51 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Copperlife FootDIMETHICONE 1%Tommie Copper, Inc.cb825d2c-6333-3c1f-e053-2995a90a78f32024-12-15WarningsExact identifier
application number: M016
Tommie Copper FootDIMETHICONE 1%Tommie Copper, Inc.ca3d3374-a3d4-69e5-e053-2995a90a3ece2024-12-15WarningsExact identifier
application number: M016
Evereden Healing Eczema TreatmentCOLLOIDAL OATMEALEden Brands, Inc.d43f0eaa-aab0-eaff-e053-2995a90ac5c82024-12-13WarningsExact identifier
application number: M016
Babo Fragrance Free Diaper CreamZINC OXIDEBabo Botanicals, Inc.adcd4fc7-c400-fc8e-e053-2a95a90a7e1f2024-12-12WarningsExact identifier
application number: M016
DomeboroALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEAdvantice Health, LLC.28c39200-2f7c-954b-3ce7-7349b27388122024-12-12WarningsExact identifier
application number: M016
Atopis Eczema Therapy CreamCOLLOIDAL OATMEALBionona Limited8d4b4a14-b631-f2fa-e053-2a95a90a932f2024-12-12WarningsExact identifier
application number: M016
Desitin Daily Defense Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLCb6e0d1a3-e469-4102-916b-d5cc8ca12e732024-12-11WarningsExact identifier
application number: M016
Little Me Multipurpose Baby BalmWHITE PETROLATUMShalom International Corpe09518f1-3691-4d85-a8e1-a5c4520570662024-12-11WarningsExact identifier
application number: M016
Blistex Ivarest Poison Ivy ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEBlistex Inc.e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a2024-12-11WarningsExact identifier
application number: M016
Deep Renewal Broad SpectrumDIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATEBlistex Inc11c0e084-dc40-4969-a176-3af4116d6f272024-12-10WarningsExact identifier
application number: M016
BOA VIDA Recovery CremeDIMETHICONECentral Solutions Incbfa07058-7a20-4b9f-bad1-4b9fb5c037e02024-12-09WarningsExact identifier
application number: M016
BOA VIDA CanopyDIMETHICONECentral Solutions Inc44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf2024-12-09WarningsExact identifier
application number: M016
DermaCen Skin ProtectantZINC OXIDECentral Solutions Inc990c3a65-bca5-1f0d-e053-2995a90aa7ae2024-12-09WarningsExact identifier
application number: M016
BOA VIDA CalvidaZINC OXIDECentral Solutions Inc48eb2031-bc80-45d5-b8b3-cc08fcab64f12024-12-09WarningsExact identifier
application number: M016
BOA VIDA CleansingDIMETHICONECentral Solutions Inc0b456b20-ab06-4adf-b5f0-1693d33979df2024-12-09WarningsExact identifier
application number: M016
SOOTHE Sensitive Skin TreatmentALLANTOIN, DIMETHICONERodan & Fields2bd8cac4-5f40-4d04-91f2-3ea8a138033b2024-12-09WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Rescue Relief TreatmentCOLLOIDAL OATMEALKenvue Brands LLCf67e528a-b822-3f7a-e053-2995a90ae7332024-12-06WarningsExact identifier
application number: M016
Humphreys MaravillaWITCH HAZELHumphreys Pharmacal, Incorporated7d403bf4-8a0d-4337-8e81-1149cd0ae1dc2024-12-06WarningsExact identifier
application number: M016
Skin Soothing CreamCOLLOIDAL OATMEALAllure Labs Inc9b1dfb4b-ce35-46a1-bfc6-ee5b871955f32024-12-05WarningsExact identifier
application number: M016
Skin Soothing Cream - Nut FreeCOLLOIDAL OATMEALAllure Labsb5eb48a5-e884-3bf6-e053-2a95a90abb972024-12-05WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199680dimethicone 1 % Topical LotionPSN2c5b96b9-24d6-4223-a63d-fe83d7c023682
199680dimethicone 10 MG/ML Topical LotionSCD2c5b96b9-24d6-4223-a63d-fe83d7c023682
199680dimethicone 1 % Topical LotionSY2c5b96b9-24d6-4223-a63d-fe83d7c023682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52000-417-1252000041712355 mL in 1 BOTTLE, PUMP (52000-417-12) 355 ml2024-05-17NoNoCurrent