Home NDC 67385-701 Pain Relieving Cream
Product NDC 67385-701
11-digit product format 673850701
Labeler code 67385
Product ID 67385-701_b5e06ab5-1bf1-4605-92b2-11a8858002ff
Type HUMAN OTC DRUG
Nonproprietary name Menthol, Unspecified Form and Methyl Salicylate
Dosage form CREAM
Route TOPICAL
Labeler Garcoa, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-03
Substance MENTHOL; METHYL SALICYLATE 2-ETHYLBUTYRATE
Active strength 1; 1.5 mg/100g; mg/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 Pain Relieving Cream
Brand name suffix Analgesic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 1 mg/100g METHYL SALICYLATE 2-ETHYLBUTYRATE 1.5 mg/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 J8D9175Q0G Internal UNII 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 67385-701-01 67385070101 907 g in 1 BOTTLE, PUMP (67385-701-01) 907 g 2026-08-03 No No Current 67385-701-02 67385070102 453.6 g in 1 JAR (67385-701-02) 453.6 g 2026-08-03 No No Current 67385-701-03 67385070103 170 g in 1 BOTTLE, DISPENSING (67385-701-03) 170 g 2026-08-03 No No Current 67385-701-04 67385070104 113 g in 1 JAR (67385-701-04) 113 g 2026-08-03 No No Current