Atopis Eczema Therapy Cream

Product NDC
71570-001
11-digit product format
715700001
Labeler code
71570
Product ID
71570-001_2919c17e-5f02-d32a-e063-6294a90abacb
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Bionona Limited
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-15
Substance
OATMEAL
Active strength
.5 g/100g
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
Atopis Eczema Therapy Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui1654149

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71570-001-012024-01-30C16284748780-11030e365-57c5-111a-e063-dadaa90a10e28d4b4a14-b631-f2fa-e053-2a95a90a932f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71570-001-01Atopis Eczema Therapy Cream75 g in 1 BOTTLECREAM752
71570-001-01Atopis Eczema Therapy Cream1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71570-001ATOPIS ECZEMA THERAPY CREAM (COLLOIDAL OATMEAL) CREAM [BIONONA LIMITED]2Current NDC, Legacy NDC, 2 package rows20241215_8d4b4a14-b631-f2fa-e053-2a95a90a932f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSN8d4b4a14-b631-f2fa-e053-2a95a90a932f2
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD8d4b4a14-b631-f2fa-e053-2a95a90a932f2
1654149colloidal oatmeal 0.5 % Topical CreamSY8d4b4a14-b631-f2fa-e053-2a95a90a932f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71570-001-01715700001011 BOTTLE in 1 CARTON (71570-001-01) / 75 g in 1 BOTTLE1 bottle2019-07-150000-00-00NoNoCurrent