Home NDC 0316-0234 Sarna
Product NDC 0316-0234
11-digit product format 003160234
Labeler code 0316
Product ID 0316-0234_483436b1-9031-4992-e063-6394a90ad0c5
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine Hydrochloride, Menthol
Dosage form LOTION
Route TOPICAL
Labeler Crown Laboratories, Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-05
Substance MENTHOL; PRAMOXINE HYDROCHLORIDE
Active strength .5; 10 mg/1000mL; mg/1000mL
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 MENTHOL .5 mg/1000mL PRAMOXINE HYDROCHLORIDE 10 mg/1000mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup 88AYB867L5 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 0316-0234-12 Sarna 355 mL in 1 BOTTLE, PUMP LOTION 355 4 0316-0234-24 Sarna 5 mL in 1 PACKET LOTION 5 4 0316-0234-75 Sarna 222 mL in 1 BOTTLE, PUMP LOTION 222 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-0234 SARNA (PRAMOXINE HYDROCHLORIDE, MENTHOL) LOTION [CROWN LABORATORIES, INC] 2 Current NDC, 3 package rows 20250323_19c41e75-a654-90cf-e063-6394a90a7e97.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 18 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0316-0234-12 00316023412 355 mL in 1 BOTTLE, PUMP (0316-0234-12) 355 ml 2024-01-05 No No Current 0316-0234-24 00316023424 5 mL in 1 PACKET (0316-0234-24) 5 ml 2024-03-13 Yes No Current 0316-0234-75 00316023475 222 mL in 1 BOTTLE, PUMP (0316-0234-75) 222 ml 2024-01-05 No No Current