Home NDC 0316-0256 Sarna
Product NDC 0316-0256
11-digit product format 003160256
Labeler code 0316
Product ID 0316-0256_483418a9-057e-f63f-e063-6294a90a4f38
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal
Dosage form LOTION
Route TOPICAL
Labeler Crown Laboratories, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-12
Substance OATMEAL
Active strength 20 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 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 Sarna
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 20 mg/mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1591951 Internal RxNorm 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 0316-0256-17 Sarna 5 mL in 1 TUBE LOTION 5 3 0316-0256-75 Sarna 222 mL in 1 TUBE LOTION 222 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-0256 SARNA (COLLOIDAL OATMEAL) LOTION [CROWN LABORATORIES, INC.] 1 Current NDC, 2 package rows 20250209_2d6b1872-9f4d-9eb3-e063-6394a90ab675.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 57 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0316-0256-17 00316025617 5 mL in 1 TUBE (0316-0256-17) 5 ml 2025-11-11 Yes No Current 0316-0256-75 00316025675 222 mL in 1 TUBE (0316-0256-75) 222 ml 2025-01-12 No No Current