FDA.reportPublic FDA data

ECZEMA

Product NDC
52915-010
Requested package NDC
52915-010-85
11-digit product format
529150010
Labeler code
52915
Product ID
52915-010_9bcc07a8-7007-4b41-83e2-d147abb7dbb1
Type
HUMAN OTC DRUG
Nonproprietary name
OATMEAL
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
ORGANIC & SUSTAINABLE BEAUTY
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-10-01
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

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
1437616Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
81eb3df4-5beb-45aa-82ca-e8b4b37e45f4Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52915-010-052020-11-06ECZEMA SHAMPOO & BODYWASH
52915-010-192020-11-06ECZEMA SHAMPOO & BODYWASH
52915-010-052019-11-27ECZEMA SHAMPOO & BODYWASH
52915-010-192019-11-27ECZEMA SHAMPOO & BODYWASH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52915-010-05ECZEMA14 mL in 1 TUBELOTION/SHAMPOO143
52915-010-19ECZEMA562 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO5623
52915-010-85ECZEMA251 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO2513

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663YECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
OATMEALACTIVE MOIETY8PI54V663YECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
allantoinINACTIVE INGREDIENT344S277G0ZECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
calendula officinalis flowerINACTIVE INGREDIENTP0M7O4Y7YDECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
decyl glucosideINACTIVE INGREDIENTZ17H97EA6YECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
fytic acidINACTIVE INGREDIENT7IGF0S7R8IECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
gluconolactoneINACTIVE INGREDIENTWQ29KQ9POTECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
jojoba oilINACTIVE INGREDIENT724GKU717MECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
lauryl glucosideINACTIVE INGREDIENT76LN7P7UCUECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
panthenolINACTIVE INGREDIENTWV9CM0O67ZECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
quillaja saponaria barkINACTIVE INGREDIENT8N0K3807ZWECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
quinoa oilINACTIVE INGREDIENTM437LS0K52ECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
viola tricolorINACTIVE INGREDIENT9Q24RAI43VECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
WaterINACTIVE INGREDIENT059QF0KO0RECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEEECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1
yucca schidigera rootINACTIVE INGREDIENTE2H9ET15ATECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52915-010ECZEMA (OATMEAL) LOTION/SHAMPOO [ORGANIC & SUSTAINABLE BEAUTY]3Current NDC, Legacy NDC, 3 package rows20241107_81eb3df4-5beb-45aa-82ca-e8b4b37e45f4.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 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nail Fungus Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-07-28WarningsExact identifier
application number: M016
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
application number: M016
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
application number: M016
Boo Boo Magic Diaper Rash CreamyZINC OXIDEAlboo Brands LLC5114aff8-adde-e610-e063-6294a90a77ea2026-07-27WarningsExact identifier
application number: M016
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
application number: M016
Hello Bello Diaper Rash CreamZINC OXIDETopiderm, Inc.e158ba31-e159-4624-a490-fe70baaf4a392026-07-24WarningsExact identifier
application number: M016
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
application number: M016
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact identifier
application number: M016
Estriol CreamESTRIOLGuangxi Keyun E-commerce Co., Ltd.4deadcb6-0d46-bdd7-e063-6294a90a26d72026-07-23WarningsExact 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437616colloidal oatmeal 1 % Medicated ShampooPSN81eb3df4-5beb-45aa-82ca-e8b4b37e45f43
1437616colloidal oatmeal 10 MG/ML Medicated ShampooSCD81eb3df4-5beb-45aa-82ca-e8b4b37e45f43
1437616colloidal oatmeal 1 % Medicated ShampooSY81eb3df4-5beb-45aa-82ca-e8b4b37e45f43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52915-010-8552915001085251 mL in 1 BOTTLE, PLASTIC (52915-010-85) 251 ml2012-10-010000-00-00NoNoCurrent