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
IngredientStrength
CAMPHOR (SYNTHETIC)32.5 mg/g
MENTHOL15 mg/g
METHYL SALICYLATE150 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A, LAV5U5022Y
Rxcui1091381

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-335-03Original Pain-A-TratePain-Relieving Cream85 g in 1 TUBECREAM854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-335ORIGINAL PAIN-A-TRATE PAIN-RELIEVING CREAM (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3Current NDC, Legacy NDC, 1 package rows20240529_cf6daad3-204e-aff3-e053-2995a90adb94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091381camphor 3.25 % / menthol 1.5 % / methyl salicylate 15 % Topical CreamPSNcf6daad3-204e-aff3-e053-2995a90adb944
1091381camphor 32.5 MG/ML / menthol 15 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCDcf6daad3-204e-aff3-e053-2995a90adb944
1091381camphor 3.25 % / menthol 1.5 % / methyl salicylate 15 % Topical CreamSYcf6daad3-204e-aff3-e053-2995a90adb944

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-335-035447303350385 g in 1 TUBE (54473-335-03) 85 g2021-10-010000-00-00NoNoCurrent