Home NDC 82345-854 Cramergesic
Product NDC 82345-854
11-digit product format 823450854
Labeler code 82345
Product ID 82345-854_410a1a4a-10dd-0fb2-e063-6294a90a82c7
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, METHYL SALICYLATE
Dosage form OINTMENT
Route TOPICAL
Labeler The Hygenic Company, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-01
Substance MENTHOL; METHYL SALICYLATE
Active strength 19; 137 mg/g; mg/g
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 Cramergesic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 19 mg/g METHYL SALICYLATE 137 mg/g
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 LAV5U5022Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1376499 Internal RxNorm lookup 1923242 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82345-854-01 Cramergesic 454 g in 1 JAR OINTMENT 454 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82345-854 CRAMERGESIC (MENTHOL, METHYL SALICYLATE) OINTMENT [THE HYGENIC COMPANY, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231106_d0ffde7a-6942-74fc-e053-2a95a90a484a.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 82345-854-01 82345085401 454 g in 1 JAR (82345-854-01) 454 g 2022-04-01 0000-00-00 No No Current