ECZEMA

Product NDC
52915-120
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52915-12052915-120-19DDiscontinued by firm2026-10-20

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52915-120-19DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52915-120-19DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52915-120-19DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52915-120-19DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52915-120-19DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52915-120-19DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52915-120-19DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52915-120-19DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52915-120-19DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52915-120-19DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52915-120-19DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52915-120-19DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52915-120-19IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52915-120-45IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52915-120-05IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52915-120-19IInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52915-120-45IInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52915-120-05IInactivated by FDA110d247fa046…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 5 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact identifier
application number: M016
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
application number: M016
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
application number: M016
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
application number: M016
DermasporinLANOLINMarie's Original Formulas LLC562f40aa-eeec-2b7c-e063-6294a90ad68d2026-07-22WarningsExact identifier
application number: M016
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
application number: M016
DermactLANOLINMarie's Original Formulas LLC57121dbe-e886-a562-e063-6294a90a367f2026-07-22WarningsExact identifier
application number: M016
Universal WITCH HAZELWITCH HAZELUniversal Distribution Center LLC7e0b56ef-fa41-4862-b387-5b58d81d67d42026-07-22WarningsExact identifier
application number: M016
Aveeno Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
application number: M016
DERMFREE SCAR SHEETSSILICONE GEL 1% SCAR SHEETSJiangxi Yudexi Pharmaceutical Co., LTD4a4ce316-4b92-7e81-e063-6294a90af6db2026-07-21WarningsExact identifier
application number: M016
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
application number: M016
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
application number: M016
DoveMEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BARConopco d/b/a Unilever56bd6fcb-c762-4e5a-e063-6394a90a34382026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINPMI Branded Pharmaceuticals, Inc.25bc1eae-3502-4c63-bd8a-43be2dfb0d6d2026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINL. Perrigo Company9c3d9e08-9428-4b28-82a2-0cb24c3c92a32026-07-16WarningsExact identifier
application number: M016
aftershaveCERAMIDE NPShengnan (Guangzhou) Cosmetics Co., LTD56a17ac9-803b-932c-e063-6394a90aae902026-07-15WarningsExact identifier
application number: M016
Clear Root Labs Wound CareCRL WOUND CARE OINTMENTAidance Scientific Inc. DBA Aidance Skincare & Topicals56a6dbc7-5001-c095-e063-6294a90a1aa02026-07-15WarningsExact 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
52915-120-025291501200257 mL in 1 JAR (52915-120-02) 57 ml2012-12-010000-00-00NoNoCurrent
52915-120-055291501200514 mL in 1 TUBE (52915-120-05) 14 ml2012-12-010000-00-00NoNoCurrent
52915-120-1952915012019562 mL in 1 BOTTLE, PUMP562 mlHistorical
52915-120-4552915012045133 mL in 1 CONTAINER (52915-120-45) 133 ml2012-12-010000-00-00NoNoCurrent