Home NDC 70000-0398 Leader Poison Ivy Wash
Product NDC 70000-0398
11-digit product format 700000398
Labeler code 70000
Product ID 70000-0398_1855aebf-a13d-5bc2-e063-6394a90a3296
Type HUMAN OTC DRUG
Nonproprietary name pramoxine hydrochloride lotion
Dosage form LOTION
Route TOPICAL
Labeler Cardinal Health, 110 dba Leader
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-02-15
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 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 70000-0398 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 70000-0398 70000-0398-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 Leader Poison Ivy Wash
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 1247251 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 70000-0398-1 Leader Poison Ivy Wash 177 mL in 1 CONTAINER LOTION 177 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0398 LEADER POISON IVY WASH (PRAMOXINE HYDROCHLORIDE LOTION) LOTION [CARDINAL HEALTH, 110 DBA LEADER] 5 Current NDC, Legacy NDC, 1 package rows 20240514_81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c.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 50 of 152 · 3,029 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 70000-0398-1 70000039801 177 mL in 1 CONTAINER (70000-0398-1) 177 ml 2019-02-15 0000-00-00 No No Current