FDA.reportPublic FDA data

PAIN THERAPY

Product NDC
76348-640
Requested package NDC
76348-640-05
11-digit product format
763480640
Labeler code
76348
Product ID
76348-640_c29c1aea-5e8c-61fd-e053-2995a90a9b22
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Methyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Renu Laboratories, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-05-14
Marketing end
0000-00-00
Substance
MENTHOL; METHYL SALICYLATE
Active strength
2 g/112g; g/112g
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76348-64076348-640-05IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-640-042025-01-30C16284748780-12cef2736-67e3-d83d-e063-dadaa90ab31fRSD EMU OIL PAIN THERAPY
76348-640-052025-01-30C16284748780-12cef2736-9de2-d83d-e063-dadaa90ab31fRSD EMU OIL PAIN THERAPY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-640-04PAIN THERAPY112 g in 1 TUBECREAM1121
76348-640-05PAIN THERAPY112 g in 1 JARCREAM1121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-640PAIN THERAPY (MENTHOL, METHYL SALICYLATE) CREAM [RENU LABORATORIES, INC.]1Legacy NDC, 1 package rows20210518_c2500db1-eccc-9166-e053-2a95a90a450a.zip
76348-640PAIN THERAPY (MENTHOL, METHYL SALICYLATE) CREAM [RENU LABORATORIES, INC.]1Legacy NDC, 1 package rows20210519_c29c250f-39be-7bef-e053-2a95a90a3d6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2198895menthol 2 % / menthyl salicylate 10 % Topical CreamPSNc2500db1-eccc-9166-e053-2a95a90a450a1
2198895menthol 2 % / menthyl salicylate 10 % Topical CreamPSNc29c250f-39be-7bef-e053-2a95a90a3d6e1
2198895menthol 20 MG/ML / menthyl salicylate 100 MG/ML Topical CreamSCDc2500db1-eccc-9166-e053-2a95a90a450a1
2198895menthol 20 MG/ML / menthyl salicylate 100 MG/ML Topical CreamSCDc29c250f-39be-7bef-e053-2a95a90a3d6e1
2198895menthol 2 % / menthyl salicylate 10 % Topical CreamSYc2500db1-eccc-9166-e053-2a95a90a450a1
2198895menthol 2 % / menthyl salicylate 10 % Topical CreamSYc29c250f-39be-7bef-e053-2a95a90a3d6e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76348-640-0576348064005112 g in 1 JAR (76348-640-05) 112 g2021-05-140000-00-00NoNoCurrent