Eczema Care Moisturizing

Product NDC
57337-101
11-digit product format
573370101
Labeler code
57337
Product ID
57337-101_83966e75-3cf0-410b-e053-2a91aa0a90f3
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
LOTION
Route
TOPICAL
Labeler
Rejoice International Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-03-08
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 Care Moisturizing
Brand name suffix
3 oz.
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-101-01Eczema Care Moisturizing3 oz.85 mL in 1 TUBELOTION851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-101ECZEMA CARE MOISTURIZING 3 OZ. (COLLOIDAL OATMEAL) LOTION [REJOICE INTERNATIONAL INC.]1Current NDC, Legacy NDC, 1 package rows20190309_83967d26-159a-e95c-e053-2991aa0af53a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-101-015733701010185 mL in 1 TUBE (57337-101-01) 85 ml2019-03-080000-00-00NoNoCurrent