FDA.reportPublic FDA data

Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC

Product NDC
75849-897
11-digit product format
758490897
Labeler code
75849
Product ID
75849-897_d492a160-8eea-49bf-a0fa-b918c9aec441
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
LABORATORIOS QUANTIUM LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
3; 3; 10 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)3 g/100g
MENTHOL, UNSPECIFIED FORM3 g/100g
METHYL SALICYLATE10 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A, LAV5U5022Y
Rxcui2673206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75849-897-03Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC90 g in 1 TUBECREAM901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75849-897VALTRUM IMMEDIATE ACTION TOPICAL ANALGESIC (CAMPHOR, MENTHOL, METHYL SALICYLATE) CREAM [LABORATORIOS QUANTIUM LLC]1Current NDC, 1 package rows20240116_c4efa317-8dd1-49e1-b7ca-9df2147edd3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2673206camphor 3 % / menthol 3 % / methyl salicylate 10 % Topical CreamPSNc4efa317-8dd1-49e1-b7ca-9df2147edd3e1
2673206camphor 30 MG/ML / menthol 30 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCDc4efa317-8dd1-49e1-b7ca-9df2147edd3e1
2673206camphor 3 % / menthol 3 % / methyl salicylate 10 % Topical CreamSYc4efa317-8dd1-49e1-b7ca-9df2147edd3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75849-897-037584908970390 g in 1 TUBE (75849-897-03) 90 g2024-01-01NoNoCurrent