FDA.reportPublic FDA data

DERMASIL DRYSKIN

Product NDC
76184-0101
Requested package NDC
76184-0101-2
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 59 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
application number: M016
Best Choice Diaper RashZINC OXIDETrifecta Pharmaceuticals USA LLC1be37841-e0a8-a0de-e063-6294a90a9eb12024-06-27WarningsExact identifier
application number: M016
Gas Relief Ultra StrengthSIMETHICONEWalgreens00a9164a-1817-4130-9c7f-9f5833c9690f2024-06-26WarningsExact identifier
application number: M016
Astonea Skin ProtectantZINC OXIDEASTONEA LABS PRIVATE LIMITEDe3c7a515-3e77-da85-e053-2995a90a3ee12024-06-25WarningsExact identifier
application number: M016
Astonea Vitamin A and DWHITE PETROLATUMASTONEA LABS PRIVATE LIMITEDef7c357b-5ff6-b9d7-e053-2a95a90a1dcf2024-06-25WarningsExact identifier
application number: M016
ZOEY NATURALS DIAPER CreamZINC OXIDEAbsolutely Natural70fac4d6-8833-4799-b6b6-796f8f13f80e2024-06-25WarningsExact identifier
application number: M016
Medicated BodyMENTHOL AND ZINC OXIDEUniversal Distribution Center LLC2a59a847-cc7a-42cf-b49a-92e7254c16292024-06-19WarningsExact identifier
application number: M016
THERA Moisturizing Body ShieldDIMETHICONEMcKesson Medical-Surgical Inc.56869b64-11ee-4df6-8102-ce5818e0116e2024-06-18WarningsExact identifier
application number: M016
DimethiconeSKIN PROTECTANTMcKesson96886b33-44d4-5a2a-e053-2a95a90a505e2024-06-18WarningsExact identifier
application number: M016
Derma E Eczema ReliefOATMEALderma e767c4a76-8ccb-4530-9b4b-a7ea1a596c7f2024-06-18WarningsExact identifier
application number: M016
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact identifier
application number: M016
THERA Calazinc Body ShieldZINC OXIDEMcKesson Medical-Surgical Inc.974b1046-83ee-4207-91d3-40982beb9c632024-06-17WarningsExact identifier
application number: M016
DimethiconeBODY CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
application number: M016
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
application number: M016
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
application number: M016
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.186a9642-cd73-adfb-e063-6394a90a75c72024-05-14WarningsExact identifier
application number: M016
Honest Eczema BalmCOLLOIDAL OATMEALThe Honest Company, Inc.35b8bc5c-420e-4d31-9659-f36cabbd897a2024-05-14WarningsExact identifier
application number: M016
Extra Strength Itch StoppingITCH STOPPING CREAMUniversal Distribution Centre LLCb9a42aa3-1903-76f0-e053-2a95a90a51d12024-05-13WarningsExact 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
76184-0101-276184010102236 mL in 1 TUBE (76184-0101-2) 236 ml2017-08-300000-00-00NoNoCurrent