FDA.reportPublic FDA data

Eczema Cream

Product NDC
85303-001
11-digit product format
853030001
Labeler code
85303
Product ID
85303-001_30c943aa-d9dd-5c16-e063-6294a90a3c58
Type
HUMAN OTC DRUG
Nonproprietary name
Eczema Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Kyte Baby LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-01
Substance
OATMEAL
Active strength
1 g/100mL
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 Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL1 g/100mL

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
30c943aa-d9dc-5c16-e063-6294a90a3c58Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85303-001-01Eczema Cream100 mL in 1 BOTTLE, PUMPCREAM1001

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 37 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
The Zoeun Skin Nourishing CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42849f5c-a983-c3ce-e063-6394a90a2fb52025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon Body WashCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4285320a-bf0b-915d-e063-6394a90a9cfd2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon GelCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42859de3-15dd-c7b9-e063-6394a90af5012025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon Hair EssenceCOLLOIDAL OATMAELSturgeonbio Co.,Ltd.4285eb13-d1a2-0663-e063-6294a90ac40f2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Total Care CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.428643c3-e932-4db5-e063-6294a90ac36c2025-10-01WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEGeri-Gentle Corporationf5cfab62-8aab-4109-b15b-4fe380f7cb9e2025-09-29WarningsExact identifier
application number: M016
GoodSense Petroleum JellyWHITE PETROLATUMGOOD SENSE3492f044-250e-45f7-8638-e3c55713e0f52025-09-29WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC2a028465-1dff-4ae7-abf6-7521c2784dd12025-09-26WarningsExact identifier
application number: M016
Johnsons Baby First Touch Gift SetZINC OXIDEKenvue Brands LLC3f838eb7-42a3-c96b-e063-6294a90a74912025-09-26WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly OriginalWHITE PETROLATUMVeridian Healthcare1fb96a6c-7d13-4ccf-8fa6-55ec79e6877c2025-09-25WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly Baby FreshWHITE PETROLATUMVeridian Healthcare0d3e6c1a-3ba9-4442-bae0-27312d658d072025-09-25WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly Cocoa ButterWHITE PETROLATUMVeridian Healthcare5c7d9eb6-c129-4fd9-9671-2e0f0453fd282025-09-25WarningsExact identifier
application number: M016
SKIN TAG REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD3ee79d66-e728-48dd-e063-6394a90a64632025-09-16WarningsExact identifier
application number: M016
ProCure LanaCareLANOLIN 50%Twin Med LLC3aabd4ea-107c-a02c-e063-6294a90aee072025-09-15WarningsExact identifier
application number: M016
ProCure LanaCareLANOLIN 30%Twin Med LLC3aad8395-6dc2-f600-e063-6294a90a6e9a2025-09-15WarningsExact identifier
application number: M016
ProCure DryDroxALUMINUM HYDROXIDE GEL 2%Twin Med LLC3ab4efb6-bd31-2583-e063-6294a90a415b2025-09-15WarningsExact identifier
application number: M016
ProCure Petroleum100% WHITE PETROLATUMTwin Med LLC3eddf0e7-8e9d-a311-e063-6394a90ad1562025-09-15WarningsExact identifier
application number: M016
NOURISHING HAND SANITIZER SPRAYSCHLORHEXIDINE DIGLUCONATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3e95a30c-8ed3-30ed-e063-6294a90a24172025-09-12WarningsExact identifier
application number: M016
I.C. Ivy BlockZINC ACETATER & R Lotion, Incdb263f4a-56a1-432c-b2e8-2a9bdd3ff1292025-09-10WarningsExact identifier
application number: M016
RoyceDerm Eczema Relief CreamCOLLOIDAL OATMEAL 1%RoyceDerm LLC3e09f000-01d2-0d21-e063-6294a90ac5482025-09-05WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN30c943aa-d9dc-5c16-e063-6294a90a3c581
240651colloidal oatmeal 10 MG/ML Topical CreamSCD30c943aa-d9dc-5c16-e063-6294a90a3c581
240651Avena sativa 1 % Topical CreamSY30c943aa-d9dc-5c16-e063-6294a90a3c581
240651colloidal oatmeal 1 % Topical CreamSY30c943aa-d9dc-5c16-e063-6294a90a3c581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85303-001-0185303000101100 mL in 1 BOTTLE, PUMP (85303-001-01) 100 ml2025-10-13NoNoCurrent