ECZEMA

Product NDC
52915-010
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

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52915-010-199bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52915-010-059bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52915-010-19110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage52915-010-05110d247fa046…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
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 48 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TANZINC OXIDEBentley Laboratories, LLC7920708a-6fa7-4bc8-94ba-096e77d9d7e12024-12-27WarningsExact identifier
application number: M016
AD Medicated RashAD MEDICATED RASHWellSpring Pharmaceutical Corporationaac345bf-ea66-4f5b-a497-c24ea72f93ea2024-12-27WarningsExact identifier
application number: M016
ZO Skin Health Post Procedure Recovery SystemALUMINUM ACETATEZO Skin Health, Inc.3b977415-2bf4-43a9-bb48-1eb023ca4f532024-12-27WarningsExact identifier
application number: M016
terrasil Scar RecoveryALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2f91ff-a447-9d2a-e063-6394a90a84f82024-12-26WarningsExact identifier
application number: M016
WITCH HAZELWITCH HAZELCHAIN DRUG MARKETING ASSOCIATION INCbdccee3f-0ad8-4264-a65f-ae86aed6bf032024-12-26WarningsExact identifier
application number: M016
All Over Lavender RosemaryCOLLOIDAL OAT OINTMENTTubby Todd29f46671-7467-95c9-e063-6294a90a13542024-12-23WarningsExact identifier
application number: M016
Sweet Cheeks Diaper SprayerZINC OXIDE DIAPER PASTE SPRAYTubby Todd29f4aa3c-d10e-52a5-e063-6294a90acc4b2024-12-23WarningsExact identifier
application number: M016
calamineCALAMINE AND ZINC OXIDEWALGREEN COMPANYfed3026b-3473-26fe-e053-6294a90a8aa22024-12-23WarningsExact identifier
application number: M016
CUREFINIPETROLATUM, COD LIVER OILMiramar Cosmetics, Inc DBA Miramar Labfc9211db-71aa-44d8-a00b-65f1482d39812024-12-23WarningsExact identifier
application number: M016
CUREFINIPETROLATUMMiramar Cosmetics, Inc DBA Miramar Lab6a2610ca-ca80-451f-8fed-b982443a10b92024-12-23WarningsExact identifier
application number: M016
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC453dffec-de9d-0eac-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC455a16fd-9ce5-6bef-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMTrifecta Pharmaceuticals USA LLCf1eb0ec2-98e7-13a2-e053-2a95a90a29382024-12-20WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDEPharmacy Value Alliance, LLC38018e3f-3778-01d1-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
DiaperRashOintmentZINC OXIDEPharmacy Value Alliance, LLC3aace6d8-d24c-00e1-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M016
Medicated Body PowderMENTHOLNew Pride Corpf0f0e332-cb93-42a7-e053-2995a90ac4ae2024-12-19WarningsExact identifier
application number: M016
Health Smart Medicated BodyMENTHOL AND ZINC OXIDEInternational Wholesale Inc dba Home Smart Products044870e2-ebac-a095-e063-6294a90a27512024-12-19WarningsExact identifier
application number: M016
White Rain Original PetroleumWHITE PETROLEUMINTERNATIONAL WHOLESALE INC.d6ebe00c-b692-5171-e053-2a95a90a976c2024-12-19WarningsExact identifier
application number: M016
Health Smart Original PetroleumWHITE PETROLEUMHome Smart Productsaedf746f-4c49-421d-a666-1ba02e8fb17d2024-12-19WarningsExact identifier
application number: M016
white rain Cocoa Butter Petroleum JellyWHITE PETROLATUMINTERNATIONAL WHOLESALE INC.d7068e2b-c3b2-d16d-e053-2a95a90a6dd22024-12-19WarningsExact 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
52915-010-055291500100514 mL in 1 TUBE (52915-010-05) 14 ml2012-10-010000-00-00NoNoCurrent
52915-010-1952915001019562 mL in 1 BOTTLE, PUMP (52915-010-19) 562 ml2012-10-010000-00-00NoNoCurrent
52915-010-8552915001085251 mL in 1 BOTTLE, PLASTIC (52915-010-85) 251 ml2012-10-010000-00-00NoNoCurrent