Home NDC 61577-4030-3 SOMBRA COOL THERAPY
Product NDC 61577-4030
Requested package NDC 61577-4030-3
11-digit product format 615774030
Labeler code 61577
Product ID 61577-4030_a033c021-5750-9c78-e053-2a95a90a09d9
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form GEL
Route TOPICAL
Labeler SOMBRA COSMETICS INC.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2017-10-20
Marketing end 0000-00-00
Substance MENTHOL
Active strength 0 g/g
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61577-4030-1 SOMBRA COOL THERAPY 3628.7 g in 1 BOTTLE, PUMP GEL 3628.7 18 61577-4030-2 SOMBRA COOL THERAPY 907.2 g in 1 BOTTLE, PUMP GEL 907.2 18 61577-4030-3 SOMBRA COOL THERAPY 226.8 g in 1 JAR GEL 226.8 18 61577-4030-4 SOMBRA COOL THERAPY 113.4 g in 1 JAR GEL 113.4 18 61577-4030-5 SOMBRA COOL THERAPY 85 g in 1 BOTTLE, PLASTIC GEL 85 18 61577-4030-6 SOMBRA COOL THERAPY 5 g in 1 POUCH GEL 5 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61577-4030 SOMBRA COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.] 18 Legacy NDC, 6 package rows 20230306_a2d403f7-aad0-4692-a36f-ee25a84a013f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61577-4030-3 61577403003 226.8 g in 1 JAR (61577-4030-3) 226.8 g 2017-10-20 0000-00-00 No No Current