Kalaya Extra Strength Pain Relief Gel with Arnica

Product NDC
43493-0012
11-digit product format
434930012
Labeler code
43493
Product ID
43493-0012_40a7e598-1e29-4590-e063-6394a90acbba
Type
HUMAN OTC DRUG
Nonproprietary name
methyl salicylate, menthol, camphor
Dosage form
GEL
Route
TOPICAL
Labeler
Avaria Health & Beauty Corp
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-16
Substance
CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE
Active strength
4; 4; 11 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
Kalaya Extra Strength Pain Relief Gel with Arnica
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)4 g/100g
LEVOMENTHOL4 g/100g
METHYL SALICYLATE11 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, BZ1R15MTK7, LAV5U5022Y

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43493-0012-0Kalaya Extra Strength Pain Relief Gel with Arnica100 g in 1 TUBEGEL1003
43493-0012-0Kalaya Extra Strength Pain Relief Gel with Arnica1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43493-0012KALAYA EXTRA STRENGTH PAIN RELIEF GEL WITH ARNICA (METHYL SALICYLATE, MENTHOL, CAMPHOR) GEL [AVARIA HEALTH & BEAUTY CORP]2Current NDC, 2 package rows20241121_b6a6237d-b471-4102-b5df-fc389f5f9258.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43493-0012-0434930012001 TUBE in 1 CARTON (43493-0012-0) / 100 g in 1 TUBE1 tube2023-12-01NoNoCurrent