Home NDC 70983-022 Restoral
Product NDC 70983-022
11-digit product format 709830022
Labeler code 70983
Product ID 70983-022_485269a3-5a54-ae1e-e063-6294a90ae1de
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form OINTMENT
Route TOPICAL
Labeler Saje Natural Business Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-02-01
Substance MENTHOL
Active strength .2 g/100g
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 Restoral
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL .2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 418609 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 70983-022-01 Restoral 54.1 g in 1 CONTAINER OINTMENT 54.1 9 70983-022-01 Restoral 1 in 1 BOX OINTMENT 1 9 70983-022-02 Restoral 13.5 g in 1 CONTAINER OINTMENT 13.5 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70983-022 RESTORAL (MENTHOL) OINTMENT [SAJE NATURAL BUSINESS INC.] 8 Current NDC, Legacy NDC, 3 package rows 20231006_5b6176c1-9ed9-1950-e053-2a91aa0a434e.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.
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 70983-022-01 70983002201 1 CONTAINER in 1 BOX (70983-022-01) / 54.1 g in 1 CONTAINER 1 container 2018-09-12 0000-00-00 No No Current 70983-022-02 70983002202 13.5 g in 1 CONTAINER (70983-022-02) 13.5 g 2018-09-12 0000-00-00 No No Current