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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONCardinal Health, 110 dba Leader7f733c0a-82b2-d3b0-e053-2991aa0a6b0f2024-05-13WarningsExact identifier
application number: M016
Walgreens Maximum Diaper RashZINC OXIDEWalgreens Company5eb2152f-6fa2-4191-878a-207416e698182024-05-07WarningsExact identifier
application number: M016
Cetaphil Eczema Rapid Relief CreamCOLLOIDAL OATMEALGalderma Laboratories, L.P.02a405fa-8ae9-41e9-b86f-ef5fb6e3844a2024-05-02WarningsExact identifier
application number: M016
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
application number: M016
Diaper Rash Cream 40% ZINCZINC OXIDEASTONEA LABS PRIVATE LIMITED16da985a-6210-ec82-e063-6294a90a132d2024-04-24WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
application number: M016
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
application number: M016
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
application number: M016
ARC Skin ProtectantALLANTOINAnjon Biologics, Incf4ff79dd-cb38-4cca-9631-a2758a1718732024-04-18WarningsExact identifier
application number: M016
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
application number: M016
Chapstick Moisturizer Variety PackAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCbfb9a2d5-1ad2-45b8-a215-9d1370af53372024-04-12WarningsExact 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