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

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 28 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a33f9a9-1fdc-7cdf-e063-6294a90adca12026-03-25WarningsExact identifier
application number: M017
EjaGuardLIDOCAINEMOLANSPACE INC475f64ef-d636-7e87-e063-6294a90ae32f2026-03-25WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4e53d29c-ed3c-f481-e063-6294a90a31812026-03-25WarningsExact identifier
application number: M017
Topicaine UltraTOPICAINE ULTRAOncora Pharma, LLCe052f718-700a-44e0-8770-65451b812ee12026-03-24WarningsExact identifier
application number: M017
Hot Pap CataplasmaMETHYL SALICYLATE, VANILLYL NONYLAMIDEMasaem Company4dbeda13-b198-0cf0-e063-6294a90a81802026-03-24WarningsExact identifier
application number: M017
Barmicil Anti-itchHYDROCORTISONEOPMX LLC850084c3-1dd4-eb8d-e053-2a91aa0a130b2026-03-24WarningsExact identifier
application number: M017
Jeil Hangbang Paff Soo S CataplasmaGLYCOL SALICYLATE, L-MENTHOLMasaem Company4dd040db-07cf-361a-e063-6394a90a80012026-03-24WarningsExact identifier
application number: M017
Zenol Double ActionMETHYL SALICYLATE, L-MENTHOLBA TRADE INC4da998fc-75a3-583f-e063-6394a90a59c72026-03-23WarningsExact identifier
application number: M017
Ultra Strength Topical Pain Relief CreamCAMPHOR, MENTHOL, METHYL SALICYLATEJ C UDEOZOR & SONS GLOBAL INDUSTRIES LTD4db9ae57-4ab4-8fe4-e063-6394a90a7e512026-03-23WarningsExact identifier
application number: M017
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ONALIVIO TOTAL ROLL ONEVI LABS4da01338-8739-08a8-e063-6294a90ae1572026-03-22WarningsExact identifier
application number: M017
DR SANA ALIVIO TOTAL ALIVIO TOTALALIVIO TOTALEVI LABS4da1c3b8-9af2-6e9f-e063-6394a90a86ae2026-03-22WarningsExact identifier
application number: M017
SORE NO MOREMENTHOL CAMPHORSOMBRA COSMETICS INC.80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd2026-03-20WarningsExact identifier
application number: M017
CVS Health Antiseptic Wound WashLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy53ac017a-eccb-3b24-e054-00144ff88e882026-03-20WarningsExact identifier
application number: M017
Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2%ANTI ITCH GELWalgreens3d6e8c62-2fcc-51c2-e063-6394a90a33f72026-03-20WarningsExact identifier
application number: M017
ANIXIKE NumbingMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5c52d7-8e81-b62f-e063-6394a90ad03e2026-03-19WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d47e8c7-d293-bf63-e063-6294a90a5fd92026-03-18WarningsExact identifier
application number: M017
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCf7aa9330-c47c-4d2f-b784-11b831d919d62026-03-18WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack99726aa3-3b45-4175-8471-279419af54572026-03-18WarningsExact identifier
application number: M017
Dr.Harry COMFORT ZONE CreamLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% COMFORT ZONE CREAMJiangxi Yudexi Pharmaceutical Co., LTD4d32b89f-72e8-bc93-e063-6394a90a0bc82026-03-17WarningsExact identifier
application number: M017
MiloRod Ultra Muscle Rub Fast-Acting Pain ReliefCAPSAICIN, MENTHOLMilo Rod Import & Export, Inc.c3622dc3-0c05-47c9-b70b-4989467819062026-03-17WarningsExact 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