FDA.reportPublic FDA data

Herbal Utaplas External Analgesic Plaster

Product NDC
82198-0016
11-digit product format
821980016
Labeler code
82198
Product ID
82198-0016_0b32b98c-2483-8d0c-e063-6294a90a90b1
Type
HUMAN OTC DRUG
Nonproprietary name
menthol, methyl salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
Big 5 Nutrition LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
.06; .1 g/g; g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Herbal Utaplas External Analgesic Plaster
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM.06 g/g
METHYL SALICYLATE.1 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, LAV5U5022Y

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82198-0016-1Herbal Utaplas External Analgesic Plaster3.1 g in 1 PATCHPATCH3.11
82198-0016-1Herbal Utaplas External Analgesic Plaster10 in 1 BAGPATCH101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82198-0016HERBAL UTAPLAS EXTERNAL ANALGESIC PLASTER (MENTHOL, METHYL SALICYLATE) PATCH [BIG 5 NUTRITION LLC]1Current NDC, 2 package rows20240101_aeaf070f-4512-4b8f-9bd8-960f6bb82881.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82198-0016-18219800160110 PATCH in 1 BAG (82198-0016-1) / 3.1 g in 1 PATCH10 patch2024-01-01NoNoCurrent