Home NDC 54473-335 Original Pain-A-Trate
Product NDC 54473-335
11-digit product format 544730335
Labeler code 54473
Product ID 54473-335_4746eee3-184f-ac88-e063-6294a90a29a5
Type HUMAN OTC DRUG
Nonproprietary name Camphor and Menthol and Methyl Salicylate
Dosage form CREAM
Route TOPICAL
Labeler Melaleuca, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-10-01
Substance CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength 32.5; 15; 150 mg/g; mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Original Pain-A-Trate
Brand name suffix Pain-Relieving Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAMPHOR (SYNTHETIC) 32.5 mg/g MENTHOL 15 mg/g METHYL SALICYLATE 150 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5TJD82A1ET Internal UNII lookup L7T10EIP3A Internal UNII lookup LAV5U5022Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1091381 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 54473-335-03 Original Pain-A-TratePain-Relieving Cream 85 g in 1 TUBE CREAM 85 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-335 ORIGINAL PAIN-A-TRATE PAIN-RELIEVING CREAM (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240529_cf6daad3-204e-aff3-e053-2995a90adb94.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 1 of 1 · 1 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 54473-335-03 54473033503 85 g in 1 TUBE (54473-335-03) 85 g 2021-10-01 0000-00-00 No No Current