FDA.reportPublic FDA data

SOOTHE Moisturizing Rescue Cream

Product NDC
14222-2430
11-digit product format
142222430
Labeler code
14222
Product ID
14222-2430_695fafcf-e87a-4e92-8e85-bb1a6b9429d9
Type
HUMAN OTC DRUG
Nonproprietary name
OATMEAL
Dosage form
CREAM
Route
TOPICAL
Labeler
Rodan & Fields
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-09
Substance
OATMEAL
Active strength
.01 g/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
SOOTHE Moisturizing Rescue Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL.01 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui240651

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-2430-12023-12-06C16284748780-10191ceaa-6d44-198a-e063-dbdaa90aec3eDrug Facts
14222-2430-22023-12-06C16284748780-10191ceaa-6d44-198a-e063-dbdaa90aec3eDrug Facts
14222-2430-32023-12-06C16284748780-10191ceaa-6d44-198a-e063-dbdaa90aec3eDrug Facts
14222-2430-12023-07-28C16284748780-10191ceaa-6d44-198a-e063-dbdaa90aec3eDrug Facts
14222-2430-22023-07-28C16284748780-10191ceaa-6d44-198a-e063-dbdaa90aec3eDrug Facts
14222-2430-32023-07-28C16284748780-10191ceaa-6d44-198a-e063-dbdaa90aec3eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14222-2430-1SOOTHE Moisturizing Rescue Cream50 mL in 1 TUBECREAM504
14222-2430-1SOOTHE Moisturizing Rescue Cream1 in 1 CARTONCREAM14
14222-2430-2SOOTHE Moisturizing Rescue Cream1 in 1 CARTONCREAM14
14222-2430-2SOOTHE Moisturizing Rescue Cream12 mL in 1 TUBECREAM124
14222-2430-3SOOTHE Moisturizing Rescue Cream2 mL in 1 PACKETCREAM24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14222-2430SOOTHE MOISTURIZING RESCUE CREAM (OATMEAL) CREAM [RODAN & FIELDS]4Current NDC, Legacy NDC, 5 package rows20231207_91163267-c2aa-47b3-b290-d1605536d806.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN91163267-c2aa-47b3-b290-d1605536d8064
240651colloidal oatmeal 10 MG/ML Topical CreamSCD91163267-c2aa-47b3-b290-d1605536d8064
240651Avena sativa 1 % Topical CreamSY91163267-c2aa-47b3-b290-d1605536d8064
240651colloidal oatmeal 1 % Topical CreamSY91163267-c2aa-47b3-b290-d1605536d8064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14222-2430-1142222430011 TUBE in 1 CARTON (14222-2430-1) / 50 mL in 1 TUBE1 tube2021-03-090000-00-00NoNoCurrent
14222-2430-2142222430021 TUBE in 1 CARTON (14222-2430-2) / 12 mL in 1 TUBE1 tube2021-06-010000-00-00NoNoCurrent
14222-2430-3142222430032 mL in 1 PACKET (14222-2430-3) 2 ml2022-04-120000-00-00NoNoCurrent