Barrier Repair

Product NDC
85884-261
11-digit product format
858840261
Labeler code
85884
Product ID
85884-261_49ac2d2c-42bc-bdaf-e063-6294a90a6ac4
Type
HUMAN OTC DRUG
Nonproprietary name
Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Steel City Health Private Limited
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-23
Substance
DIMETHICONE 350; OATMEAL
Active strength
.03; .0025 g/g; g/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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Barrier Repair
Brand name suffix
Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL.03 g/g
DIMETHICONE 350.0025 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y, 2Y53S6ATLU

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85884-261-03Barrier RepairCream100 g in 1 JARCREAM1002
85884-261-04Barrier RepairCream1 in 1 JARCREAM12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85884-261-0385884026103100 g in 1 JAR100 gHistorical
85884-261-04858840261041 JAR in 1 JAR (85884-261-04) / 100 g in 1 JAR (85884-261-03) 1 jar2026-01-23NoNoHistorical