ECZEMA

Product NDC
52915-120
Requested package NDC
52915-120-05
11-digit product format
529150120
Labeler code
52915
Product ID
52915-120_5fe6372b-07b4-40f8-9efe-2892256f2454
Type
HUMAN OTC DRUG
Nonproprietary name
OATMEAL
Dosage form
CREAM
Route
TOPICAL
Labeler
ORGANIC & SUSTAINABLE BEAUTY
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-12-01
Substance
OATMEAL
Active strength
10 mg/mL
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
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52915-12052915-120-05IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52915-12052915-120-05IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL10 mg/mL

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
926706b5-0a08-4604-b5ad-3b3ddfd7f02dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52915-120-052020-11-09ECZEMA CREAM
52915-120-192020-11-09ECZEMA CREAM
52915-120-452020-11-09ECZEMA CREAM
52915-120-052019-11-27ECZEMA CREAM
52915-120-192019-11-27ECZEMA CREAM
52915-120-452019-11-27ECZEMA CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52915-120-02ECZEMA57 mL in 1 JARCREAM573
52915-120-05ECZEMA14 mL in 1 TUBECREAM143
52915-120-19ECZEMA562 mL in 1 BOTTLE, PUMPCREAM5623
52915-120-45ECZEMA133 mL in 1 CONTAINERCREAM1333

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663YECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
OATMEALACTIVE MOIETY8PI54V663YECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
allantoinINACTIVE INGREDIENT344S277G0ZECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
calendula officinalis flowerINACTIVE INGREDIENTP0M7O4Y7YDECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
canola oilINACTIVE INGREDIENT331KBJ17RKECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
caprylhydroxamic acidINACTIVE INGREDIENTUPY805K99WECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
cetearyl olivateINACTIVE INGREDIENT58B69Q84JOECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
clary sage oilINACTIVE INGREDIENT87L0D4U3M0ECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
fytic acidINACTIVE INGREDIENT7IGF0S7R8IECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
glyceryl caprylateINACTIVE INGREDIENTTM2TZD4G4AECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
lavender oilINACTIVE INGREDIENTZBP1YXW0H8ECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7UECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
rosemaryINACTIVE INGREDIENTIJ67X351P9ECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
sorbitan olivateINACTIVE INGREDIENTMDL271E3GRECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
viola tricolorINACTIVE INGREDIENT9Q24RAI43VECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
WaterINACTIVE INGREDIENT059QF0KO0RECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1
yucca schidigera rootINACTIVE INGREDIENTE2H9ET15ATECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52915-120ECZEMA (OATMEAL) CREAM [ORGANIC & SUSTAINABLE BEAUTY]3Current NDC, Legacy NDC, 4 package rows20241107_926706b5-0a08-4604-b5ad-3b3ddfd7f02d.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 1 of 70 · 1,388 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN926706b5-0a08-4604-b5ad-3b3ddfd7f02d3
240651colloidal oatmeal 10 MG/ML Topical CreamSCD926706b5-0a08-4604-b5ad-3b3ddfd7f02d3
240651Avena sativa 1 % Topical CreamSY926706b5-0a08-4604-b5ad-3b3ddfd7f02d3
240651colloidal oatmeal 1 % Topical CreamSY926706b5-0a08-4604-b5ad-3b3ddfd7f02d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52915-120-055291501200514 mL in 1 TUBE (52915-120-05) 14 ml2012-12-010000-00-00NoNoCurrent