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

openFDA Listing Details

Product ID
49967-571_52f75c0f-c209-9fcb-e063-6294a90a1eae
SPL ID
52f75c0f-c209-9fcb-e063-6294a90a1eae
Product type
HUMAN OTC DRUG
Finished product
Yes
Brand name base
KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery
Generic name
Colloidal oatmeal
Dosage form
CREAM
Route
TOPICAL
Marketing start
2025-11-15
Marketing category
OTC MONOGRAPH DRUG
Application number
M016
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]
Listing expiration
2027-12-31

openFDA Active Ingredients

IngredientStrength
OATMEAL10 mg/mL

openFDA Harmonized Identifiers

FieldValues
Unii8PI54V663Y
Spl Set Id22e088b9-b3b1-4c34-be12-a5a31200ec25
Manufacturer NameLOreal USA Products Inc

openFDA Package Details

Package NDCDescriptionMarketing startSample
49967-571-011 TUBE in 1 CARTON (49967-571-01) / 14 mL in 1 TUBE2025-11-15No
49967-571-0228 mL in 1 JAR (49967-571-02)2025-11-15No
49967-571-0350 mL in 1 JAR (49967-571-03)2025-11-15No
49967-571-043 mL in 1 PACKET (49967-571-04)2026-05-14No
49967-571-05125 mL in 1 JAR (49967-571-05)2026-05-29No
49967-571-06150 mL in 1 POUCH (49967-571-06)2026-05-29No

Related Records

Related UNII Ingredients

UNIIPreferred termMatched term
8PI54V663YOATMEALOATMEAL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49967-571-01499670571011 TUBE in 1 CARTON (49967-571-01) / 14 mL in 1 TUBE1 tube2025-11-15NoNoHistorical
49967-571-024996705710228 mL in 1 JAR (49967-571-02) 28 ml2025-11-15NoNoHistorical
49967-571-034996705710350 mL in 1 JAR (49967-571-03) 50 ml2025-11-15NoNoHistorical
49967-571-04499670571043 mL in 1 PACKET (49967-571-04) 3 ml2026-05-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsL’Oreal USA Products Inc | L'OREAL USA, INC.2026-05-29HUMAN OTC DRUG LABEL8
Drug FactsL’Oreal USA Products Inc | L'OREAL USA, INC.2026-05-14HUMAN OTC DRUG LABEL7
Drug FactsL’Oreal USA Products Inc | L'OREAL USA, INC.2025-06-30HUMAN OTC DRUG LABEL5