Ultra Pain-A-Trate

Product NDC
54473-334
11-digit product format
544730334
Labeler code
54473
Product ID
54473-334_4746dd93-6d18-ced6-e063-6394a90aea2c
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
3.4; 8.5; 25.5 g/85g; g/85g; g/85g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ultra Pain-A-Trate
Brand name suffix
Pain-Relieving Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)3.4 g/85g
MENTHOL8.5 g/85g
METHYL SALICYLATE25.5 g/85g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A, LAV5U5022Y
Rxcui283083

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-334-03Ultra Pain-A-TratePain-Relieving Cream85 g in 1 TUBECREAM854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-334ULTRA PAIN-A-TRATE PAIN-RELIEVING CREAM (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3Current NDC, Legacy NDC, 1 package rows20240529_cf48b8ca-651d-20d4-e053-2a95a90a4310.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSNcf48b8ca-651d-20d4-e053-2a95a90a43104
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCDcf48b8ca-651d-20d4-e053-2a95a90a43104
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSYcf48b8ca-651d-20d4-e053-2a95a90a43104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-334-035447303340385 g in 1 TUBE (54473-334-03) 85 g2021-10-010000-00-00NoNoCurrent