Home NDC 63347-420 OrthoNesic Pain Relieving Gel
Product NDC 63347-420
11-digit product format 633470420
Labeler code 63347
Product ID 63347-420_a8fe10de-60fb-4197-a42c-37802f676b53
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, CAMPHOR
Dosage form GEL
Route CUTANEOUS
Labeler Blaine Labs Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-12
Substance MENTHOL; CAMPHOR (SYNTHETIC)
Active strength 3.5; 3 g/100g; 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 OrthoNesic Pain Relieving Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 3.5 g/100g CAMPHOR (SYNTHETIC) 3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup 5TJD82A1ET Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2745970 Internal RxNorm lookup 2745972 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63347-420-01 63347042001 170 g in 1 TUBE (63347-420-01) 170 g 2026-06-12 No No Current