Home NDC 80216-111 SANO TI AMO RELIEF AND REPAIR PAIN RELIEF
Product NDC 80216-111
11-digit product format 802160111
Labeler code 80216
Product ID 80216-111_052ea67f-e484-4ac7-91d9-a474b49bc554
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)
Dosage form CREAM
Route TOPICAL
Labeler Sano Ti Amo, LLC
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2019-10-08
Marketing end 0000-00-00
Substance CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM
Active strength 3 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2023-12-31
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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 80216-111-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 80216-111-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 80216-111-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 80216-111-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 80216-111-02 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 80216-111-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 80216-111-02 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80216-111-02 SANO TI AMO RELIEF AND REPAIR PAIN RELIEF 60 mL in 1 CONTAINER CREAM 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80216-111 SANO TI AMO RELIEF AND REPAIR PAIN RELIEF (MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)) CREAM [SANO TI AMO, LLC] 4 Legacy NDC, 1 package rows 20250323_205a89c4-2ae4-4072-af5c-a9ce6154a3f9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80216-111-02 80216011102 60 mL in 1 CONTAINER (80216-111-02) 60 ml 2019-10-08 0000-00-00 No No Current