FDA.reportPublic FDA data

RoyceDerm Eczema Relief Body Wash

Product NDC
85424-027
11-digit product format
854240027
Labeler code
85424
Product ID
85424-027_54e74eb4-1b43-a748-e063-6394a90aeb16
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal 2%
Dosage form
GEL
Route
TOPICAL
Labeler
RoyceDerm LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-13
Substance
OATMEAL
Active strength
6.6 g/330g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
RoyceDerm Eczema Relief Body Wash
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL6.6 g/330g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8PI54V663YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2172890Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54e74eb4-1b42-a748-e063-6394a90aeb16Available on FDA.report

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 46 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rico Hand SanitizerALCOHOLHANUL CO.,LTDa6065fcd-3968-d5a1-e053-2a95a90ab8d62025-01-20WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4465b-6e46-51e2-e063-6294a90a695f2025-01-16WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4a2b0-f586-3ab1-e063-6294a90aa1ed2025-01-16WarningsExact identifier
application number: M016
Dermoia Manuka Honey EczemaOATMEALTREASUREWISE LLC18c174de-6626-45ee-a6aa-f75a48daab8d2025-01-15WarningsExact identifier
application number: M016
AllantoinMEDICINAL MASSAGE OILCarolina Cannabis Creations L.L.C04b5619b-2122-f159-e063-6394a90a2e052025-01-15WarningsExact identifier
application number: M016
Skin Barista 2in1 White Body PerfectionDIMETHICONEPioom Cosmetic Co.,ltd2d7fc20c-31a7-195b-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M016
Skin Barista Rice Bran Cleansing FoamALLANTOINPioom Cosmetic Co.,ltd2d7fc7f6-1e89-116c-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M016
Hammertech Vitamin A and DWHITE PETROLATUMHAMMER TECH LLCffe96aa1-db6b-33e4-e053-6394a90a7e4e2025-01-14WarningsExact identifier
application number: M016
NOON Cartessa Accelerate ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd400ead81-ab07-400f-b261-db330e0fd0042025-01-14WarningsExact identifier
application number: M016
NOON Post Procedure ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd9d1d11b4-40ff-4ea8-a3af-655f457c05f12025-01-14WarningsExact identifier
application number: M016
OLP diaper Rash cream A and DZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACYd6faa4d9-751c-a1b6-e053-2a95a90aee5b2025-01-09WarningsExact identifier
application number: M016
ANTI-ITCHZINC ACETATE , DIPHENHYDRAMINEOL PHARMA TECH, LLCb79d3096-c609-e710-e053-2995a90a8da22025-01-09WarningsExact identifier
application number: M016
ANTIBACTERIAL DREAMY FLORALSGLYCERINQuimicas Handal de Centroamerica SA de CV09f73bec-516d-90f0-e063-6394a90aecab2025-01-08WarningsExact identifier
application number: M016
AOAO Repair Foot CreamUREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL.Guangdong Junhui Biotechnology Co.,LTD21064e84-c827-ca82-e063-6394a90a6c652025-01-08WarningsExact identifier
application number: M016
A0A0 Rice Ceramide Anti Wrinkle Age Essence Box SetBIFIDA FERMENT LYSATE,ORYZA SATIVA (RICE) EXTRACT,CERAMIDE NP,COLLAGEN,TOCOPHEROL.Guangdong Junhui Biotechnology Co., LTD22736b2d-45a0-49b6-e063-6394a90a7b0b2025-01-08WarningsExact identifier
application number: M016
Body Milk for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,THEOBROMA CACAO (COCOA) SEED BUTTERGuangzhou Senmai Biotechnology Co.1dcd94dc-214d-de72-e063-6294a90a695f2025-01-08WarningsExact identifier
application number: M016
Stretch Marks creamSESAMUM INDICUM (SESAME) SEED EXTRACT,PRUNUS PERSICA (PEACH) RESIN EXTRACT,STERCULIA URENS GUM,TRIPEPTIDE-1,HEXAPEPTIDE-9,ACETYL TETRAPEPTIDE-9,PALMITOYL PENTAPEPTIDE-4,PALMITOYL TETRAPEPTIDE-7,ACETYL HEXAPEPTIDE-8.Guangzhou Senmai Biotechnology Co.1e827483-259a-d12f-e063-6394a90a78852025-01-08WarningsExact identifier
application number: M016
Body oil for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILGuangzhou Senmai Biotechnology Co.1daeb2e8-f18c-06c3-e063-6294a90a63852025-01-08WarningsExact identifier
application number: M016
AOA0 Snail Ginseng CreamSNAIL SECRETION FILTRATE,PANAX GINSENG ROOT EXTRACT,COLLAGEN,TOCOPHEROL,ASCORBIC ACID.Guangdong Junhui Biotechnology Co., LTD22873a99-1032-f4ec-e063-6394a90a64322025-01-08WarningsExact identifier
application number: M016
Massage cream for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL,BUTYROSPERMUM PARKII (SHEA) BUTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,CERAMIDE NP,SOLUBLE COLLAGEN,HYDROLYZED ELASTIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OILGuangzhou Senmai Biotechnology Co.1dce7cf1-1fb8-e14e-e063-6394a90ae34a2025-01-08WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-027-0185424002701330 g in 1 CARTON (85424-027-01) 330 g2026-07-13NoNoCurrent