FDA.reportPublic FDA data

DR. WOLFES WARM THERAPY

Product NDC
61577-1010
Requested package NDC
61577-1010-4
11-digit product format
615771010
Labeler code
61577
Product ID
61577-1010_9a63c7c4-52e4-335e-e053-2a95a90a6bca
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL AND CAMPHOR
Dosage form
GEL
Route
TOPICAL
Labeler
SOMBRA COSMETICS INC.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-05-23
Marketing end
0000-00-00
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
0 g/g; g/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage61577-101061577-1010-4IInactivated by FDA2026-08-03

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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-1010-42025-01-30C16284748780-1f386c649-cd52-0266-e053-dadaa90a7c1aDr. Wolfe's Warm Therapy
61577-1010-42023-03-09C16284748780-1f386c649-cd52-0266-e053-dadaa90a7c1aDr. Wolfe's Warm Therapy
61577-1010-42023-01-30C16284748780-1f386c649-cd52-0266-e053-dadaa90a7c1aDr. Wolfe's Warm Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-1010-4DR. WOLFES WARM THERAPY113.4 g in 1 JARGEL113.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-1010DR. WOLFES WARM THERAPY (MENTHOL AND CAMPHOR) GEL [SOMBRA COSMETICS INC.]3Legacy NDC, 1 package rows20230310_b684c83a-fd34-4576-b6de-367822cea5d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630714camphor 3 % / menthol 3 % Topical GelPSNb684c83a-fd34-4576-b6de-367822cea5d13
630714camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical GelSCDb684c83a-fd34-4576-b6de-367822cea5d13
630714camphor 3 % / menthol 3 % Topical GelSYb684c83a-fd34-4576-b6de-367822cea5d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-1010-461577101004113.4 g in 1 JAR (61577-1010-4) 113.4 g2019-05-290000-00-00NoNoCurrent