FDA.reportPublic FDA data

Skin Soothing Cream - Nut Free

Product NDC
62742-4194
11-digit product format
627424194
Labeler code
62742
Product ID
62742-4194_288ed65b-ec90-58e2-e063-6294a90a7373
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Allure Labs
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-07
Substance
OATMEAL
Active strength
1 mg/g
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
Skin Soothing Cream - Nut Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui240651

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4194-1Skin Soothing Cream - Nut Free113.5 g in 1 JARCREAM113.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4194SKIN SOOTHING CREAM - NUT FREE (COLLOIDAL OATMEAL) CREAM [ALLURE LABS]2Current NDC, Legacy NDC, 1 package rows20241208_b5eb48a5-e884-3bf6-e053-2a95a90abb97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSNb5eb48a5-e884-3bf6-e053-2a95a90abb972
240651colloidal oatmeal 10 MG/ML Topical CreamSCDb5eb48a5-e884-3bf6-e053-2a95a90abb972
240651Avena sativa 1 % Topical CreamSYb5eb48a5-e884-3bf6-e053-2a95a90abb972
240651colloidal oatmeal 1 % Topical CreamSYb5eb48a5-e884-3bf6-e053-2a95a90abb972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62742-4194-162742419401113.5 g in 1 JAR (62742-4194-1) 113.5 g2020-12-070000-00-00NoNoCurrent