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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283083Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d99a900-60e0-454c-98e0-2c63eb910cf1Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 18 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze Overnight Roll-onMENTHOLReckitt Benckiser LLCf67d7b7a-8922-73f6-e053-2995a90a2e802026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight ReliefMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC07be6e88-1850-4d6a-946d-f03830b8c4a22026-05-15WarningsExact identifier
application number: M017
Biofreeze Roll-On and Overnight Roll-OnMENTHOLReckitt Benckiser LLC4d3dcb8f-2075-6bbc-e063-6394a90a49922026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6bef9ccb-7a5a-4c67-b1bc-a92b167312da2026-05-15WarningsExact identifier
application number: M017
Biofreeze Roll-OnMENTHOLReckitt Benckiser LLCebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb2026-05-15WarningsExact identifier
application number: M017
Biofreeze Precision Relief PenMENTHOLReckitt Benckiser LLCb4cc1db5-a33f-17bc-e053-2995a90ab7eb2026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCdb982baf-31ea-4f09-90e3-cd5facb5dfe52026-05-15WarningsExact identifier
application number: M017
Biofreeze Professional Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCf62f8ec3-593d-480a-85a0-01fcd7f1790c2026-05-15WarningsExact identifier
application number: M017
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ONMENTHOLReckitt Benckiser LLC8af185ad-719e-4684-89c0-9c17c12774992026-05-15WarningsExact identifier
application number: M017
PERFORM COOL and SOOTHING PAIN RELIEVINGMENTHOLReckitt Benckiser LLCef158f63-2d75-47a3-b94a-2d821d5118632026-05-15WarningsExact identifier
application number: M017
KY Duration for HimLIDOCAINEReckitt Benckiser LLC83cc86bd-3303-4956-a198-fae85b6e34e12026-05-15WarningsExact identifier
application number: M017
4% LIDOCAINE PATCHES4% LIDOCAINEShenzhen Huayuan Hengsheng Technology Co., Ltd.4f53cfd3-a7c4-e308-e063-6294a90ad6982026-05-14WarningsExact identifier
application number: M017
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLCardinal Health, 110 dba LEADER77066d01-75b0-4a8d-88d3-c639626d33262026-05-14WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnLIDOCAINETrifecta Pharmaceuticals USA51cb6797-55ec-7a7a-e063-6294a90a90ee2026-05-14WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnMENTHOLTrifecta Pharmaceuticals USA51b403dc-fc9b-0cad-e063-6394a90af0812026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC5edddb99-6596-4a3b-b361-1cc04d032c312026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC684faf63-5e44-4471-8384-e8fa7c0d842a2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC4c798b06-6ee5-41d1-8a14-f6889512ade32026-05-13WarningsExact identifier
application number: M017
BIOFREEZEMENTHOLReckitt Benckiser LLC83d5c2f2-2413-4d28-83b2-0808d0917b4d2026-05-13WarningsExact identifier
application number: M017
Scalpicin Anti-Itch Maximum StrengthHYDROCORTISONEReckitt Benckiser LLC7b1a29fa-b266-43e6-a87b-aa3c96ab40412026-05-13WarningsExact identifier
application number: M017

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