Home NDC 0316-0230 Sarna
Product NDC 0316-0230
11-digit product format 003160230
Labeler code 0316
Product ID 0316-0230_48341fc1-10ea-47fa-e063-6394a90abe32
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine Hydrochloride
Dosage form LOTION
Route TOPICAL
Labeler Crown Laboratories
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
Substance PRAMOXINE HYDROCHLORIDE
Active strength 10 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 0316-0230 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0316-0230 0316-0230-75 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 PRAMOXINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1246075 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0316-0230-12 Sarna 355 mL in 1 BOTTLE, PUMP LOTION 355 5 0316-0230-25 Sarna 5 mL in 1 PACKET LOTION 5 5 0316-0230-57 Sarna 222 mL in 1 BOTTLE, PUMP LOTION 222 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-0230 SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [CROWN LABORATORIES] 20 Current NDC, Legacy NDC 20240602_7b2ff573-ca59-d69a-e053-2a91aa0abcec.zip 0316-0230 SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [CROWN LABORATORIES] 2 Current NDC, Legacy NDC, 3 package rows 20250323_19b0ce1b-e147-01a1-e063-6394a90af808.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 151 · 3,020 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0316-0230-12 00316023012 355 mL in 1 BOTTLE, PUMP (0316-0230-12) 355 ml 2024-01-01 No No Current 0316-0230-25 00316023025 5 mL in 1 PACKET (0316-0230-25) 5 ml 2024-03-18 Yes No Current 0316-0230-57 00316023057 222 mL in 1 BOTTLE, PUMP (0316-0230-57) 222 ml 2024-01-01 No No Current 0316-0230-75 00316023075 222 mL in 1 BOTTLE, PUMP (0316-0230-75) 222 ml 2018-12-01 0000-00-00 No No Current