FDA.reportPublic FDA data

KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery

Product NDC
49967-571
11-digit product format
499670571
Labeler code
49967
Product ID
49967-571_51cd5434-a9f9-917f-e063-6394a90aa98a
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
L�Oreal USA Products Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-571-01KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery14 mL in 1 TUBECREAM147
49967-571-01KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery1 in 1 CARTONCREAM17
49967-571-02KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery28 mL in 1 JARCREAM287
49967-571-03KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery50 mL in 1 JARCREAM507
49967-571-04KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery3 mL in 1 PACKETCREAM37

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN22e088b9-b3b1-4c34-be12-a5a31200ec258
240651colloidal oatmeal 10 MG/ML Topical CreamSCD22e088b9-b3b1-4c34-be12-a5a31200ec258
240651Avena sativa 1 % Topical CreamSY22e088b9-b3b1-4c34-be12-a5a31200ec258
240651colloidal oatmeal 1 % Topical CreamSY22e088b9-b3b1-4c34-be12-a5a31200ec258

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49967-571-01499670571011 TUBE in 1 CARTON (49967-571-01) / 14 mL in 1 TUBE1 tube2025-11-15NoNoCurrent
49967-571-024996705710228 mL in 1 JAR (49967-571-02) 28 ml2025-11-15NoNoCurrent
49967-571-034996705710350 mL in 1 JAR (49967-571-03) 50 ml2025-11-15NoNoCurrent
49967-571-04499670571043 mL in 1 PACKET (49967-571-04) 3 ml2026-05-14NoNoCurrent
49967-571-0549967057105125 mL in 1 JAR (49967-571-05)125 ml2026-05-290Current
49967-571-0649967057106150 mL in 1 POUCH (49967-571-06)150 ml2026-05-290Current