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 64 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Consortium5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b2023-12-20WarningsExact identifier
application number: M016
Best Choice Medicated CalamineZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO.5d6c668a-80b4-de18-e053-2991aa0a38fb2023-12-20WarningsExact identifier
application number: M016
Premiere Value CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Consortium5c8bde5a-591d-085f-e053-2991aa0a56af2023-12-20WarningsExact identifier
application number: M016
Best Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO5d6c51b8-47f8-c38b-e053-2991aa0a0f232023-12-20WarningsExact identifier
application number: M016
Health Care CalamineCALAMINE 8% AND ZINC OXIDE 8%Great Lakes Wholesale, Marketing and Sales Inc5d8f02fb-0794-8ec2-e053-2991aa0aac632023-12-20WarningsExact identifier
application number: M016
Harris Teetter CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEHarris Tetter, LLC.5c7a7418-c973-2869-e053-2991aa0ab4f52023-12-20WarningsExact identifier
application number: M016
Harris Teeter CalamineZINC OXIDEHarris Teeter, LLC.86021cc5-fea7-4363-8fb2-2b0484437fe82023-12-20WarningsExact identifier
application number: M016
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact 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