FDA.reportPublic FDA data

ECZEMA INTENSIVE DAILY RELIEF BODY

Product NDC
61328-210
11-digit product format
613280210
Labeler code
61328
Product ID
61328-210_48339459-e0d7-1451-e063-6294a90ac093
Type
HUMAN OTC DRUG
Nonproprietary name
colloidal oatmeal cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Skinfix, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-07
Substance
OATMEAL
Active strength
2 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ECZEMA INTENSIVE DAILY RELIEF BODY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui1189915

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61328-210-00ECZEMA INTENSIVE DAILY RELIEF BODY177 g in 1 TUBECREAM1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61328-210ECZEMA INTENSIVE DAILY RELIEF BODY (COLLOIDAL OATMEAL CREAM) CREAM [SKINFIX, INC.]2Current NDC, 1 package rows20240108_0be3c631-bc9b-00a9-e063-6394a90abcbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1189915colloidal oatmeal 2 % Topical CreamPSN0be3c631-bc9b-00a9-e063-6394a90abcbb4
1189915colloidal oatmeal 20 MG/ML Topical CreamSCD0be3c631-bc9b-00a9-e063-6394a90abcbb4
1189915colloidal oatmeal 2 % Topical CreamSY0be3c631-bc9b-00a9-e063-6394a90abcbb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61328-210-0061328021000177 g in 1 TUBE (61328-210-00) 177 g2024-01-07NoNoHistorical