Home NDC 63347-112 RevitaDERM PSORIASIS
Product NDC 63347-112
11-digit product format 633470112
Labeler code 63347
Product ID 63347-112_52aacff7-6265-4446-9dd0-dfef99dd4785
Type HUMAN OTC DRUG
Nonproprietary name COAL TAR
Dosage form OINTMENT
Route TOPICAL
Labeler Blaine Labs Inc.
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-11-01
Substance COAL TAR
Active strength 2 mg/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 63347-112 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63347-112 63347-112-01 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 RevitaDERM PSORIASIS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COAL TAR 2 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R533ESO2EC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 317080 Internal RxNorm lookup 1297944 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 63347-112-01 RevitaDERM PSORIASIS 118 mL in 1 JAR OINTMENT 118 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63347-112 REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.] 4 Current NDC, Legacy NDC, 1 package rows 20231222_06ad14d3-4ff4-4283-8197-8626aad3b8d0.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 16 of 31 · 615 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 63347-112-01 63347011201 118 mL in 1 JAR (63347-112-01) 118 ml 2011-11-01 0000-00-00 No No Current