Home NDC 16864-680 Dermoplast Pain Relieving
Product NDC 16864-680
11-digit product format 168640680
Labeler code 16864
Product ID 16864-680_29147ec9-a0e6-1a10-e063-6394a90a44f7
Type HUMAN OTC DRUG
Nonproprietary name BENZOCAINE and LEVOMENTHOL
Dosage form SPRAY
Route TOPICAL
Labeler Advantice Health, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-01-01
Substance BENZOCAINE; LEVOMENTHOL
Active strength 200; 5 mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dermoplast Pain Relieving
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g LEVOMENTHOL 5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup BZ1R15MTK7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199864 Internal RxNorm lookup 763484 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16864-680-01 Dermoplast Pain Relieving 78 g in 1 CAN SPRAY 78 6 16864-680-02 Dermoplast Pain Relieving 56 g in 1 CAN SPRAY 56 6 16864-680-03 Dermoplast Pain Relieving 85 g in 1 CAN SPRAY 85 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16864-680 DERMOPLAST PAIN RELIEVING (BENZOCAINE AND LEVOMENTHOL) SPRAY [ADVANTICE HEALTH, LLC] 6 Current NDC, Legacy NDC, 3 package rows 20241215_2347f0b8-d463-422d-8583-65624d9a1a91.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 77 of 153 · 3,057 matching rows.
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 16864-680-01 16864068001 78 g in 1 CAN (16864-680-01) 78 g 2014-01-01 0000-00-00 No No Current 16864-680-02 16864068002 56 g in 1 CAN (16864-680-02) 56 g 2014-01-01 0000-00-00 No No Current 16864-680-03 16864068003 85 g in 1 CAN (16864-680-03) 85 g 2014-01-01 0000-00-00 No No Current