FDA.reportPublic FDA data

Eczema Relief Cream

Product NDC
71521-025
11-digit product format
715210025
Labeler code
71521
Product ID
71521-025_4df3cc3e-fa40-d4d3-e063-6394a90a64d9
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Lavior Pharma Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-31
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 Relief Cream
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
bdd2fc9f-2718-1d88-e053-2995a90a8682Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71521-025-152026-01-29C16284748780-149896155-a9e0-586f-e063-e6dba90add90bdd2fc9f-2718-1d88-e053-2995a90a8682
71521-025-502026-01-29C16284748780-149896155-a9e0-586f-e063-e6dba90add90bdd2fc9f-2718-1d88-e053-2995a90a8682

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71521-025-15Eczema Relief Cream15 g in 1 TUBECREAM159
71521-025-50Eczema Relief Cream50 g in 1 BOTTLE, PUMPCREAM509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71521-025ECZEMA RELIEF CREAM (COLLOIDAL OATMEAL) CREAM [LAVIOR PHARMA INC]8Current NDC, Legacy NDC, 2 package rows20241024_bdd2fc9f-2718-1d88-e053-2995a90a8682.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 31 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pediadermics eczema 3COLLOIDAL OATMEAL, DIMETHICONERenu Laboratories, LLCaf861f0b-4387-6861-e053-2995a90a8bfa2025-12-02WarningsExact identifier
application number: M016
Flexitol Face and Eyelid EczemaOATMEALLaCorium Health USA Inc.f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee652025-12-02WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 41%Twin Med LLC3d36e664-ac10-72eb-e063-6294a90a49c42025-12-01WarningsExact identifier
application number: M016
ProCure Vitamin A and DWHITE PETROLATUM 93.4%Twin Med LLC3d385a07-2a12-fce7-e063-6294a90a32d62025-12-01WarningsExact identifier
application number: M016
ESTRIOLESTRIOLShenzhen Mengyue Technology Co., Ltd.44de9eb4-080e-bfbc-e063-6394a90ac0ea2025-12-01WarningsExact identifier
application number: M016
CareALL Creamy Petroleum JellyPETROLATUMNew World Imports, Ince13fea4e-bd6d-425a-aa7e-1d41dc36bf002025-12-01WarningsExact identifier
application number: M016
CareALL Creamy Cocoa Butter Petroleum JellyPETROLATUMNew World Imports, Inc9358b8ef-df14-45fc-9bfd-9052577a1f882025-12-01WarningsExact identifier
application number: M016
CAREALL Zinc OxideZINC OXIDENew World Imports Incaa9ae4d1-4229-4894-9eaf-8588b28674722025-12-01WarningsExact identifier
application number: M016
CAREALL PetroleumPETROLATUMNew World Imports, Inc47e999de-08bd-4121-b6d0-270cc603b56d2025-12-01WarningsExact identifier
application number: M016
HOEGOA Growth Hair SerumGLYCERINShantou Oralhoe Biotechnology Co., Ltd.44b6609f-c58b-b6ac-e063-6394a90a749b2025-11-29WarningsExact identifier
application number: M016
OUHOE Micro Darts Tag gone PatchGLYCERINShantou Ouhoe Technology Co., Ltd.33ce447c-facd-35fb-e063-6394a90a1ead2025-11-27WarningsExact identifier
application number: M016
OUHOE Herbal Hair OilGLYCERINShantou Ouhoe Technology Co., Ltd.30c3df30-e0c6-4efa-e063-6294a90ac40a2025-11-27WarningsExact identifier
application number: M016
OUHOE Aloe Soothing Sun CreamGLYCERINShantou Ouhoe Technology Co., Ltd.326781e0-55dc-80fc-e063-6394a90a09aa2025-11-27WarningsExact identifier
application number: M016
OUHOE Ultra Anti-Acne Control GelGLYCERINShantou Ouhoe Technology Co., Ltd.3bd1b734-76b0-5264-e063-6294a90a32d02025-11-27WarningsExact identifier
application number: M016
OUHOE Lipoma CreamGLYCERINShantou Ouhoe Technology Co., Ltd.3cb4aed1-3b13-a62a-e063-6294a90a6c392025-11-27WarningsExact identifier
application number: M016
OUHOE Para CrescimentoGLYCERINShantou Ouhoe Technology Co., Ltd.42fbfcac-29ab-51f7-e063-6394a90a626f2025-11-27WarningsExact identifier
application number: M016
OUHOE Biotin With Hydrolyzed CollagenGLYCERINShantou Ouhoe Technology Co., Ltd.43138915-5fe1-6e32-e063-6294a90abefa2025-11-27WarningsExact identifier
application number: M016
EELHOE Pain Relief PatchGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.3f835843-eb04-6273-e063-6294a90ab2f02025-11-27WarningsExact identifier
application number: M016
EELHOE Skin Tag RemoverGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.32922508-74ae-8347-e063-6294a90a61542025-11-27WarningsExact identifier
application number: M016
EELHOE Bodyacne Removal CleanserGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.3bbebf1d-2e22-1427-e063-6294a90a79992025-11-27WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSNbdd2fc9f-2718-1d88-e053-2995a90a86829
240651colloidal oatmeal 10 MG/ML Topical CreamSCDbdd2fc9f-2718-1d88-e053-2995a90a86829
240651Avena sativa 1 % Topical CreamSYbdd2fc9f-2718-1d88-e053-2995a90a86829
240651colloidal oatmeal 1 % Topical CreamSYbdd2fc9f-2718-1d88-e053-2995a90a86829

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71521-025-157152100251515 g in 1 TUBE (71521-025-15) 15 g2022-03-170000-00-00NoNoCurrent
71521-025-507152100255050 g in 1 BOTTLE, PUMP (71521-025-50) 50 g2021-03-310000-00-00NoNoCurrent