Home NDC 72400-300 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Superbalm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL .57 g/.57g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8PI54V663Y Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72400-300-02 Superbalm 57 g in 1 JAR SALVE 57 4 72400-300-04 Superbalm 113 g in 1 JAR SALVE 113 4 72400-300-08 Superbalm 227 g in 1 JAR SALVE 227 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72400-300 SUPERBALM (COLLOIDAL OATMEAL 1%) SALVE [ERA ORGANICS, INC.] 2 Current NDC, 3 package rows 20240925_f5298e5e-583d-d74c-e053-2995a90affb5.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 8 of 55 · 1,088 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72400-300-02 72400030002 57 g in 1 JAR (72400-300-02) 57 g 2024-09-19 No No Current 72400-300-04 72400030004 113 g in 1 JAR (72400-300-04) 113 g 2024-09-19 No No Current 72400-300-08 72400030008 227 g in 1 JAR (72400-300-08) 227 g 2025-10-01 No No Current