FDA.reportPublic FDA data

Renew Intensive Skin Therapy

Product NDC
54473-410
11-digit product format
544730410
Labeler code
54473
Product ID
54473-410_42790fbf-5c8b-ad6b-e063-6294a90af297
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Melaleuca Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
OATMEAL
Active strength
.5 g/50mL
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
Renew Intensive Skin Therapy
Brand name suffix
Targeted Eczema Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL.5 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui240651

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-410-01Renew Intensive Skin TherapyTargeted Eczema Treatment50 mL in 1 TUBE, WITH APPLICATORCREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-410RENEW INTENSIVE SKIN THERAPY TARGETED ECZEMA TREATMENT (COLLOIDAL OATMEAL) CREAM [MELALEUCA INC.]2Current NDC, 1 package rows20240531_198c7caf-576b-1466-e063-6394a90afe25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN198c7caf-576b-1466-e063-6394a90afe253
240651colloidal oatmeal 10 MG/ML Topical CreamSCD198c7caf-576b-1466-e063-6394a90afe253
240651Avena sativa 1 % Topical CreamSY198c7caf-576b-1466-e063-6394a90afe253
240651colloidal oatmeal 1 % Topical CreamSY198c7caf-576b-1466-e063-6394a90afe253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54473-410-015447304100150 mL in 1 TUBE, WITH APPLICATOR (54473-410-01) 50 ml2024-01-01NoNoCurrent