FDA.reportPublic FDA data

DERMASIL DRYSKIN

Product NDC
76184-0101
11-digit product format
761840101
Labeler code
76184
Product ID
76184-0101_d08d5bc8-6935-4ff4-a223-c02c0887a904
Type
HUMAN OTC DRUG
Nonproprietary name
DIMETHICONE
Dosage form
LOTION
Route
TOPICAL
Labeler
Fantasia Beauty LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-30
Substance
DIMETHICONE
Active strength
.01 g/mL
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
DERMASIL DRYSKIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE.01 g/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199680Internal RxNorm lookup
880878Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a49f4be-8a73-41ca-86f4-11a707b2987aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76184-0101-2DERMASIL DRYSKIN236 mL in 1 TUBELOTION2364
76184-0101-3DERMASIL DRYSKIN429 mL in 1 BOTTLELOTION4294
76184-0101-4DERMASIL DRYSKIN535 mL in 1 BOTTLELOTION5354

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76184-0101DERMASIL DRYSKIN (DIMETHICONE) LOTION [FANTASIA BEAUTY LLC]4Current NDC, Legacy NDC, 3 package rows20250221_8a49f4be-8a73-41ca-86f4-11a707b2987a.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 62 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
XtraCare Skin Relief Oatmeal Daily MoisturizingDIMETHICONERejoice International5ae6d5d4-caff-4360-a0e7-7c8d7a9b59072024-02-28WarningsExact identifier
application number: M016
XtraCare with cooling action Oatmeal Skin Relief CalminDIMETHICONERejoice International29abd476-c32d-49f0-b283-30f4ba570ab42024-02-28WarningsExact identifier
application number: M016
MAX BARRIER Skin ProtectantZINC OXIDEGL HEALTH, INC.5eec834d-d8f3-49e3-b230-f8cf88b795e62024-02-26WarningsExact identifier
application number: M016
Rugby Petrolatum Hydrating Skin ProtectantPETROLATUMRugby Laboratoriesad63e345-1fe8-4f9a-a32e-8dfcde31bedc2024-02-12WarningsExact identifier
application number: M016
A and DPETROLATUMSafetec of America, Inc.b9afda3a-9e1d-46c1-b7aa-c3143caf709e2024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Mint BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc86fc9f3c-e35f-4988-bf19-64d9c6c85ee92024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Berry BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc827365b3-b3a5-4472-9add-f822362c47312024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Lip BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc8b4160ed-8889-4e3a-947f-a56c3324dbbe2024-02-09WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP101b9933-c2b8-0fdd-e063-6294a90a306a2024-01-29WarningsExact identifier
application number: M016
XtraCare Skin Relief Oatmeal Daily MoisturizingDIMETHICONERejoice International8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc2024-01-29WarningsExact identifier
application number: M016
Cetaphil Baby HealingPETROLATUMGalderma Laboratories, L.P.5140754e-5db0-470f-adfd-de02b184880b2024-01-29WarningsExact identifier
application number: M016
CHAPSTICK CLASSIC MEDICATEDCAMPHOR, MENTHOL, PETROLATUMHaleon US Holdings LLCb4259621-ff41-46cc-a658-b57bff3c15252024-01-23WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USAfcef17f1-84e7-a288-e053-6294a90a064b2024-01-19WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
880878Dermasil 1 % Topical LotionPSN8a49f4be-8a73-41ca-86f4-11a707b2987a4
199680dimethicone 1 % Topical LotionPSN8a49f4be-8a73-41ca-86f4-11a707b2987a4
880878dimethicone 10 MG/ML Topical Lotion [Dermasil]SBD8a49f4be-8a73-41ca-86f4-11a707b2987a4
199680dimethicone 10 MG/ML Topical LotionSCD8a49f4be-8a73-41ca-86f4-11a707b2987a4
880878Dermasil 1 % Topical LotionSY8a49f4be-8a73-41ca-86f4-11a707b2987a4
880878Dermasil 10 MG/ML Topical LotionSY8a49f4be-8a73-41ca-86f4-11a707b2987a4
199680dimethicone 1 % Topical LotionSY8a49f4be-8a73-41ca-86f4-11a707b2987a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76184-0101-176184010101214 mL in 1 TUBE (76184-0101-1) 214 ml2017-08-300000-00-00NoNoCurrent
76184-0101-276184010102236 mL in 1 TUBE (76184-0101-2) 236 ml2017-08-300000-00-00NoNoCurrent
76184-0101-376184010103429 mL in 1 BOTTLE (76184-0101-3) 429 ml2023-01-010000-00-00NoNoCurrent
76184-0101-476184010104535 mL in 1 BOTTLE (76184-0101-4) 535 ml2023-11-010000-00-00NoNoCurrent
76184-0101-576184010105296 mL in 1 TUBE (76184-0101-5) 296 ml2017-08-300000-00-00NoNoCurrent
76184-0101-676184010106296 mL in 1 BOTTLE (76184-0101-6) 296 ml2017-08-300000-00-00NoNoCurrent
76184-0101-776184010107429 mL in 1 BOTTLE (76184-0101-7) 429 ml2017-08-300000-00-00NoNoCurrent
76184-0101-876184010108535 mL in 1 BOTTLE (76184-0101-8) 535 ml2017-08-300000-00-00NoNoCurrent