FDA.reportPublic FDA data

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 61 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime 4X Medicated CreamBENZOCAINERite Aid21645ed1-2dc0-223a-e063-6394a90ab0212025-11-21WarningsExact identifier
application number: M017
4x Medicated Gum CreamBENZOCAINEAlbertsonsb81a308c-9c30-0e3d-e053-2a95a90a15d22025-11-21WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCb0edd9d9-951f-d3dd-e053-2995a90a8d5a2025-11-21WarningsExact identifier
application number: M017
Up upLIDOCAINE PAIN RELIEF MAXIMUM STRENGTH PATCHESTarget Corporation44121d40-86e1-0df6-e063-6294a90aedaf2025-11-20WarningsExact identifier
application number: M017
Up upPAIN RELIEF ADVANCED HYDROGEL PATCHESTarget Corporation44128b70-3172-ee37-e063-6294a90a705f2025-11-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCf03090fa-f7e6-f53a-e053-2a95a90aa8192025-11-20WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INCff073e47-3107-e17e-e053-6294a90a58fa2025-11-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCfc8a8f20-97ab-481e-e053-6394a90a35252025-11-20WarningsExact identifier
application number: M017
MENTHOLMENTHOLSUNSET PAIN RELIEF ROLL-ON 3OZ934d4638-b47b-187d-e053-2995a90ae69d2025-11-20WarningsExact identifier
application number: M017
FOOT PAIN RELIEF ROLL-ONLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd43edcea0-ab04-f368-e063-6294a90a817a2025-11-19WarningsExact identifier
application number: M017
Absolut Skin Corticosoothe Anti-ItchHYDROCORTISONEAbsolut Skin Incorporateddeb52218-9176-4aaa-a22f-b66dada6690f2025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch Good Neighbor PharmacyLIDOCAINEInterMed Laboratories Private Limited43f3d189-f6b7-02ed-e063-6394a90afd732025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch HealthA2ZLIDOCAINEInterMed Laboratories Private Limited43f3e288-e828-8130-e063-6394a90a6d442025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch LeaderLIDOCAINEInterMed Laboratories Private Limited42f06914-c8b8-ea9c-e063-6294a90a79e62025-11-19WarningsExact identifier
application number: M017
CVS Anti-ItchCAMPHOR, MENTHOLCVS87715662-c788-9a8d-e053-2a95a90acb532025-11-19WarningsExact identifier
application number: M017
Walgreen Anti ItchCAMPHOR, MENTHOLWalgreensb4f47a8d-d4a6-9233-e053-2a95a90afd902025-11-19WarningsExact identifier
application number: M017
Leader Anti-ItchCAMPHOR, MENTHOLLEADER/Cardinal Helath 110, Inc.9ca985c6-5017-0558-e053-2995a90a82022025-11-19WarningsExact identifier
application number: M017
CVS Anti-ItchPRAMOXINE HCLCVS87fc476a-5b12-7383-e053-2995a90a530b2025-11-19WarningsExact identifier
application number: M017
Walgreen Anti-ItchPRAMOXINE HCLWalgreensb5f9d1c5-891e-4377-e053-2995a90aa2812025-11-19WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF89f5f688-856f-f2df-e053-2995a90a73cf2025-11-19WarningsExact 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