Analgesic

Product NDC
61010-8202
11-digit product format
610108202
Labeler code
61010
Product ID
61010-8202_a4cdd5eb-fbda-4f99-b737-452a1487adfd
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-09-01
Substance
MENTHOL
Active strength
70 mg/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Analgesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL70 mg/L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-8202-0Analgesic0.088 L in 1 BOTTLE, WITH APPLICATORGEL0.0881

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-8202ANALGESIC (MENTHOL) GEL [SAFETEC OF AMERICA, INC.]1Current NDC, Legacy NDC, 1 package rows20180906_a90266d4-1e71-4805-aeca-6f8ed45135bb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61010-8202-061010820200.088 L in 1 BOTTLE, WITH APPLICATOR (61010-8202-0) 2018-09-010000-00-00NoNoCurrent