FDA.reportPublic FDA data

ECZEMA HAND RELIEF

Product NDC
61328-010
11-digit product format
613280010
Labeler code
61328
Product ID
61328-010_483370fe-3400-2af0-e063-6294a90ab6d1
Type
HUMAN OTC DRUG
Nonproprietary name
COLLOIDAL OATMEAL
Dosage form
CREAM
Route
TOPICAL
Labeler
Skinfix, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
Substance
OATMEAL
Active strength
1 g/100g
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
ECZEMA HAND RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL1 g/100g

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
240651Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0389bab7-04fb-7cfc-e063-6394a90a22d8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61328-010-00ECZEMA HAND RELIEF90 g in 1 TUBECREAM904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61328-010ECZEMA HAND RELIEF (COLLOIDAL OATMEAL) CREAM [SKINFIX, INC.]2Current NDC, 1 package rows20241228_0389bab7-04fb-7cfc-e063-6394a90a22d8.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 23 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pure petroleumWHITE PETROLATUMRite Aid Corporationf67be4cc-9983-4758-93c8-383919ec07ca2026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMRite Aid Corporation0d535736-ba61-42eb-9112-c154295372a22026-01-30Warnings, Adverse reactionsExact identifier
application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCec67a1ee-ad71-54f2-e053-2995a90a76902026-01-29WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUM7-Select7e93df71-74bd-4d95-9a64-54756c7b234a2026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
TheraCare Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare49132a75-4a16-cede-e063-6294a90a62172026-01-29WarningsExact identifier
application number: M016
TheraCare A and DLANOLIN, PETROLATUMVeridian Healthcare1303aa33-2111-b36c-e063-6294a90af1312026-01-29WarningsExact identifier
application number: M016
Zinc oxideZINC OXIDEAldi, Incd56782c1-b23c-47a9-82cb-d7dbb0ac7aa32026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMAldi, Inc94fea2f2-fea8-4923-afc6-36068bc2fef52026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
DAILY MOISTURIZINGDIMETHICONE LOTIONAldi, Inc4ad18f4a-e148-4bf5-a04b-4168fa48eeb22026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALAldi, Inc79f498af-c207-4f85-bf1b-fb2ee8379fd82026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC066b1313-aed8-9436-e063-6294a90a2b112026-01-29WarningsExact identifier
application number: M016
Equate Scar TopicalALLANTOINWalMartcf511a02-355c-4286-82fa-6f0c4a2448232026-01-29WarningsExact identifier
application number: M016
TriDerma Stubborn Diaper Rash ReliefALLANTOIN, DIMETHICONEGenuine Virgin Aloe Corporationf8f3ae0b-aa55-4c2f-8823-54268524917b2026-01-28WarningsExact identifier
application number: M016
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M016
Equate Chafing GelDIMETHICONEWalmart Inc06665504-040c-a806-e063-6294a90acedc2026-01-27WarningsExact 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 0ILDongguan Xiaogoubeige trading company Ltd.496af9a1-7249-622f-e063-6394a90aa2842026-01-27WarningsExact identifier
application number: M016
Herpecin LZINC OXIDE, DIMETHICONEFocus Consumer Healthcare, LLC488a29c3-dd97-af1a-e063-6394a90aba7f2026-01-26WarningsExact identifier
application number: M016
XIMONTH Nail Nourishing PenGLYCERINShantou Ximonth Biotechnology Co., Ltd.49451717-e41c-8ae0-e063-6294a90a91ad2026-01-26WarningsExact identifier
application number: M016
Kerasal Athletes Foot Rapid Symptom Relief Medicated SoakALUMINUM SULFATE TETRADECAHYDRATE AND CALCIUM ACETATE MONOHYDRATEAdvantice Health, LLC.09a178c1-0eb1-43e5-bde8-fd27ed633d592026-01-26WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN0389bab7-04fb-7cfc-e063-6394a90a22d84
240651colloidal oatmeal 10 MG/ML Topical CreamSCD0389bab7-04fb-7cfc-e063-6394a90a22d84
240651Avena sativa 1 % Topical CreamSY0389bab7-04fb-7cfc-e063-6394a90a22d84
240651colloidal oatmeal 1 % Topical CreamSY0389bab7-04fb-7cfc-e063-6394a90a22d84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61328-010-006132800100090 g in 1 TUBE (61328-010-00) 90 g2023-10-01NoNoCurrent