Superbalm

Product NDC
72400-300
11-digit product format
724000300
Labeler code
72400
Product ID
72400-300_44994dfb-94c0-115b-e063-6294a90adff4
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal 1%
Dosage form
SALVE
Route
TOPICAL
Labeler
Era Organics, Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-19
Substance
OATMEAL
Active strength
.57 g/.57g
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
Superbalm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL.57 g/.57g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72400-300-02Superbalm57 g in 1 JARSALVE574
72400-300-04Superbalm113 g in 1 JARSALVE1134
72400-300-08Superbalm227 g in 1 JARSALVE2274

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72400-300SUPERBALM (COLLOIDAL OATMEAL 1%) SALVE [ERA ORGANICS, INC.]2Current NDC, 3 package rows20240925_f5298e5e-583d-d74c-e053-2995a90affb5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72400-300-027240003000257 g in 1 JAR (72400-300-02) 57 g2024-09-19NoNoHistorical
72400-300-0472400030004113 g in 1 JAR (72400-300-04) 113 g2024-09-19NoNoHistorical
72400-300-0872400030008227 g in 1 JAR (72400-300-08) 227 g2025-10-01NoNoHistorical