Home NDC 84293-010 Whipped Gel
Product NDC 84293-010
11-digit product format 842930010
Labeler code 84293
Product ID 84293-010_222b381c-665f-177d-e063-6394a90a3306
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal
Dosage form GEL
Route TOPICAL
Labeler OCEAN OLIVE LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-15
Substance OATMEAL
Active strength 1 mg/100g
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 Whipped Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 1 mg/100g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84293-010-01 Whipped Gel 50 g in 1 CONTAINER GEL 50 1 84293-010-02 Whipped Gel 1 in 1 BOX GEL 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84293-010 WHIPPED GEL (COLLOIDAL OATMEAL) GEL [OCEAN OLIVE LLC] 1 Current NDC, 2 package rows 20240924_222b381c-665e-177d-e063-6394a90a3306.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 38 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84293-010-01 84293001001 50 g in 1 CONTAINER 50 g Historical 84293-010-02 84293001002 1 CONTAINER in 1 BOX (84293-010-02) / 50 g in 1 CONTAINER (84293-010-01) 1 container 2024-09-15 No No Current