Home NDC 83696-601 Medterra Pain Relief Menthol Roll-On
Product NDC 83696-601
11-digit product format 836960601
Labeler code 83696
Product ID 83696-601_384365e6-a1e2-64d6-e063-6394a90a3375
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form CREAM
Route TOPICAL
Labeler Respect Manufacturing Corporation
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-01
Marketing end 2027-05-31
Substance MENTHOL, UNSPECIFIED FORM
Active strength 2.36 g/59.1g
NDC exclude flag No
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 Medterra Pain Relief Menthol Roll-On Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 2.36 g/59.1g
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 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 83696-601-60 Medterra Pain Relief Menthol Roll-On 59.1 g in 1 BOTTLE, WITH APPLICATOR CREAM 59.1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83696-601 MEDTERRA PAIN RELIEF MENTHOL ROLL-ON (MENTHOL) CREAM [RESPECT MANUFACTURING CORPORATION] 2 Current NDC, 1 package rows 20231228_05a6067a-287a-52d4-e063-6394a90a2c4e.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 48 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83696-601-60 83696060160 59.1 g in 1 BOTTLE, WITH APPLICATOR (83696-601-60) 59.1 g 2022-01-01 2027-05-31 No No Historical