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 41 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Infection Protection Wound CareALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse98d1d8c-c979-49de-9bd8-cd409efff6de2025-07-11WarningsExact identifier
application number: M016
Neosporin Lip Health Overnight Renewal TherapyPETROLATUMKenvue Brands LLC0da54fe1-c99f-4a2d-9ee5-2dc24005096c2025-07-10WarningsExact identifier
application number: M016
COCOA BUTTER PETROLEUM jellyPETROLATUMSavvy Care & Cosmetics Pvt. Ltd.397d13f1-3b86-3c76-e063-6394a90a0f242025-07-09WarningsExact identifier
application number: M016
Pipette EczemaCOLLOIDAL OATMEALPipette LLC39829827-d801-f5a7-e063-6394a90a024c2025-07-09WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEWestminster Pharmaceuticals, LLC7e045b3a-f33b-4faa-ab9b-2baec6ff79242025-07-08WarningsExact identifier
application number: M016
Desitin Multi-Purpose HealingPETROLATUMKenvue Brands LLC30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab2025-07-07WarningsExact identifier
application number: M016
Astringent SolutionALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEFirst Nation Group065c895c-7d86-f1ed-e063-6394a90a3a522025-07-07WarningsExact identifier
application number: M016
Creamy PetroleumPETROLATUMSavvy Care & Cosmetics Pvt Ltd3916daee-f8d2-e3f0-e063-6294a90a38832025-07-04WarningsExact identifier
application number: M016
Exemax CreamDIMETHICONE, ALLANTOINPureTek Corporation38e79055-df84-d314-e063-6394a90ac95f2025-07-01WarningsExact identifier
application number: M016
Procure Dimethicone 5%DIMETHICONETwin Med LLC38a7e4af-997d-549e-e063-6394a90a0bd62025-06-28WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDerma Sciences Canada Inc.37eff762-1ea9-ec66-e063-6394a90a3d102025-06-19WarningsExact identifier
application number: M016
Dr.Johnes SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLCb731c55e-31ee-429f-8432-fac7c5718d832025-06-18WarningsExact identifier
application number: M016
Dr. Johne SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLC6c5adc3c-9d45-449a-ad42-f9571851cd182025-06-18WarningsExact identifier
application number: M016
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal OatmealOATMEALTHERAPLEX, LLCe51aa467-ffe7-4c6b-8588-6df8592596d42025-06-16WarningsExact identifier
application number: M016
ZIIDII Wild Yam CreamWILD YAMGuangzhou Haishi Biological Technology Co., Ltd.3733154a-4884-9988-e063-6294a90aa78c2025-06-10WarningsExact identifier
application number: M016
Aveeno Calm Plus Restore Skin Therapy BalmCOLLOIDAL OATMEALKenvue Brands LLCdbe7a2cc-9c21-2a48-e053-2a95a90a54e22025-06-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWALGREENS2017113f-d192-5fbb-e063-6294a90a83b02025-05-31WarningsExact identifier
application number: M016
AHHH Bite ReliefSODIUM BICARBONATE7827125a1e070-9228-4ec9-e063-6294a90ad78d2025-05-27WarningsExact identifier
application number: M016
SupreH Bee Venom Skin Tag Treatment LiquidSUPREH BEE VENOM SKIN TAG REMOVER LIQUIDShenzhen Xinxin Yunhai Technology Co., Ltd.35ca9836-917a-b0ac-e063-6294a90a28a22025-05-23WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Bed Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions35d2738c-dacf-7309-e063-6294a90aab4c2025-05-23WarningsExact 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