FDA.reportPublic FDA data

Leader Ultra Strength Muscle Rub

Product NDC
70000-0208
11-digit product format
700000208
Labeler code
70000
Product ID
70000-0208_e3f093f8-52f5-4130-a42b-8b3c8eb2a138
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor (Synthetic), Menthol, Unspecified Form, and Methyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Cardinal Health, 110 dba LEADER
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-24
Substance
CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
40; 100; 300 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Ultra Strength Muscle Rub
Brand name suffix
Topical Analgesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)40 mg/g
MENTHOL, UNSPECIFIED FORM100 mg/g
METHYL SALICYLATE300 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A, LAV5U5022Y
Rxcui283083

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0208-1Leader Ultra Strength Muscle RubTopical Analgesic113 g in 1 TUBECREAM1135
70000-0208-1Leader Ultra Strength Muscle RubTopical Analgesic1 in 1 CARTONCREAM15
70000-0208-2Leader Ultra Strength Muscle RubTopical Analgesic1 in 1 CARTONCREAM15
70000-0208-2Leader Ultra Strength Muscle RubTopical Analgesic56.7 g in 1 TUBECREAM56.75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0208-1GM - Gram70000-02087f50541e-c0c9-4d35-ad89-133a2d7ea8ca12017-12-14
70000-0208-2GM - Gram70000-020819ba147a-c847-470f-9f0d-e1a851a3e46612020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0208LEADER ULTRA STRENGTH MUSCLE RUB TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [CARDINAL HEALTH, 110 DBA LEADER]4Current NDC, Legacy NDC, 4 package rows20240210_9d99a900-60e0-454c-98e0-2c63eb910cf1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSN9d99a900-60e0-454c-98e0-2c63eb910cf15
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD9d99a900-60e0-454c-98e0-2c63eb910cf15
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSY9d99a900-60e0-454c-98e0-2c63eb910cf15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0208-1700000208011 TUBE in 1 CARTON (70000-0208-1) / 113 g in 1 TUBE1 tube2017-05-240000-00-00NoNoCurrent
70000-0208-2700000208021 TUBE in 1 CARTON (70000-0208-2) / 56.7 g in 1 TUBE1 tube2017-05-240000-00-00NoNoCurrent