FDA.reportPublic FDA data

Muscle Rub

Product NDC
68788-6857
11-digit product format
687886857
Labeler code
68788
Product ID
68788-6857_3b306765-9494-417b-abae-4f995093b0e3
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Methyl salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-12-22
Marketing end
0000-00-00
Substance
MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
10 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-6857DDiscontinued by firm2026-10-05
excluded packagepackage68788-685768788-6857-8DDiscontinued by firm2026-10-05

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-6857-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-6857-8f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6857MUSCLE RUB (MENTHOL, METHYL SALICYLATE) CREAM [PREFERRED PHARMACEUTICALS INC.]8Legacy NDC20240724_68ebe7fe-b504-4fb6-b201-80ef0d79fc32.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-6857-8687886857081 TUBE in 1 CARTON (68788-6857-8) > 85 g in 1 TUBE1 tube2016-12-220000-00-00NoNoCurrent