Home NDC 70673-501 SMOOTH GATOR Head-Ezz Analgesic
Product NDC 70673-501
11-digit product format 706730501
Labeler code 70673
Product ID 70673-501_1a820f59-518c-a238-e063-6294a90a1d1f
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form CREAM
Route TOPICAL
Labeler Smooth Gator LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-13
Substance MENTHOL
Active strength 30 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 SMOOTH GATOR Head-Ezz Analgesic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 30 mg/mL
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 1442261 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 70673-501-00 SMOOTH GATOR Head-Ezz Analgesic 60 mL in 1 BOTTLE CREAM 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70673-501 SMOOTH GATOR HEAD-EZZ ANALGESIC (MENTHOL) CREAM [SMOOTH GATOR LLC] 1 Current NDC, 1 package rows 20240613_02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd.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 Sample Exclude flag Status 70673-501-00 70673050100 60 mL in 1 BOTTLE (70673-501-00) 60 ml 2024-06-13 No No Current