ICE MUSCLE RUB Leon M.C

Product NDC
69822-103
11-digit product format
698220103
Labeler code
69822
Product ID
69822-103_0b57d91e-06ca-37f8-e063-6294a90a6515
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Southern Sales & Service, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-04
Substance
MENTHOL
Active strength
.02 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69822-103-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69822-103-08IInactivated by FDAbd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69822-103-08EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
ICE MUSCLE RUB Leon M.C
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.02 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311502Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4efaf347-7406-4690-8005-e7cf2e3d4222Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-08-25Leon Ice Muscle Rub
2022-01-28Leon Ice Muscle Rub
2020-02-11Leon Ice Muscle Rub
2020-01-31Leon Ice Muscle Rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-103-08ICE MUSCLE RUB Leon M.C227 g in 1 TUBEGEL2278

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-103ICE MUSCLE RUB LEON M.C (MENTHOL) GEL [SOUTHERN SALES & SERVICE, INC.]8Current NDC, Legacy NDC, 1 package rows20231201_4efaf347-7406-4690-8005-e7cf2e3d4222.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 101 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Pain Relief Gel-Roll OnMENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.0bd62de8-ce8b-c110-e063-6294a90a98cb2025-02-07WarningsExact identifier
application number: M017
Menthol Pain Relief Gel-TubeMENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.0bb07892-824e-8691-e063-6294a90a38912025-02-07WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHOROlakino Therapeutics LLC2a41a621-c6f7-5819-e063-6394a90ae67d2025-02-07WarningsExact identifier
application number: M017
Pain Reliveing PatchLIDOCAINE 4%simple diagnostics02ed0b27-bba9-ec0c-e063-6294a90a014d2025-02-07WarningsExact identifier
application number: M017
FlexDermal Pain Relieving Roll-OnMENTHOLSOLVADERM LLCd4d8050e-0761-4491-8635-39c806701eb52025-02-06WarningsExact identifier
application number: M017
Lipo Flavonoid Ear Pain Relief Drops with 4% LidocaineLIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINEClarion Brands LLC2d7e9f6a-0f21-b103-e063-6294a90a912f2025-02-06WarningsExact identifier
application number: M017
signature care HydrocortisoneHYDROCORTISONESafeway9fe16fc5-77e3-47f5-a943-85bc6565c0d42025-02-06WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLC8803ae01-ea48-46c2-ab64-bb273de605ac2025-02-05WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine SalicylateTROLAMINE SALICYLATETELEBRANDS CORP2d685602-5cd6-3b36-e063-6394a90a3c5d2025-02-05WarningsExact identifier
application number: M017
LidocoreLIDOCAINEiON Pharma, LLC204c3e50-1ac8-f442-e063-6294a90ae7b52025-02-05WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLC2c32cfed-2022-4e7c-ae9c-ba22dbb560af2025-02-04WarningsExact identifier
application number: M017
CapsaicinCAPSAICINPHARMACURE LLCb2b2de93-d957-43d7-a2a8-b46bcaea1f0d2025-02-04WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream ExtremeMENTHOL 16%, CAMPHOR 11%Telebrands Corp2d54077e-4c8d-aaae-e063-6394a90adb412025-02-04WarningsExact identifier
application number: M017
Capsaicin External AnalgesicCAPSAICINNuCare Pharmaceuticals,Inc.fd90a67d-d60d-a849-e053-6394a90a2cc82025-02-04WarningsExact identifier
application number: M017
Rugby Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals, Inc.2d58c15a-5ddb-1b16-e063-6294a90a3fbb2025-02-04WarningsExact identifier
application number: M017
CetilarMENTHOL 1.4%PharmaNutra Usa Corp.2dd14bd4-b4e1-bc7d-e063-6394a90a1e592025-02-04WarningsExact identifier
application number: M017
Stopain Extra Strength ContinuousMENTHOLTroy Manufacturing, Inc.0d199d39-5b47-4c7f-b83a-757f39aa17b62025-02-03WarningsExact identifier
application number: M017
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare2d42192b-8889-a896-e063-6294a90a4fc82025-02-03WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving MuscleMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.96b06d3f-8685-4314-ad7d-5d2720f4dde62025-02-03WarningsExact identifier
application number: M017
Icy Hot Medicated No Mess ApplicatorMENTHOLChattem, Inc.4ce2b823-7ef5-4cca-a2d8-2fe781bc958e2025-02-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311502menthol 2 % Topical GelPSN4efaf347-7406-4690-8005-e7cf2e3d42228
311502menthol 0.02 MG/MG Topical GelSCD4efaf347-7406-4690-8005-e7cf2e3d42228
311502menthol 2 % Topical GelSY4efaf347-7406-4690-8005-e7cf2e3d42228
311502menthol 2 % topical stickSY4efaf347-7406-4690-8005-e7cf2e3d42228

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69822-103-0869822010308227 g in 1 TUBE (69822-103-08) 227 g2015-01-040000-00-00NoNoCurrent