FDA.reportPublic FDA data

Dermoplast Sunburn and Burn Relief

Product NDC
16864-681
Requested package NDC
16864-681-01
11-digit product format
168640681
Labeler code
16864
Product ID
16864-681_b30118b0-b328-4782-8f68-8f99ab19fcd7
Type
HUMAN OTC DRUG
Nonproprietary name
benzocaine and levomenthol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Advantice Health, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-05-15
Marketing end
0000-00-00
Substance
BENZOCAINE; LEVOMENTHOL
Active strength
200 mg/g; mg/g
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 packagepackage16864-68116864-681-01DDiscontinued by firm2026-08-03

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-681-01Dermoplast Sunburn and Burn Relief78 g in 1 CANSPRAY783

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-681DERMOPLAST SUNBURN AND BURN RELIEF (BENZOCAINE AND LEVOMENTHOL) SPRAY [ADVANTICE HEALTH, LLC]3Legacy NDC, 1 package rows20241215_5d9f8ac1-cf42-4e30-bb3f-f59723f95b1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199864benzocaine 20 % / menthol 0.5 % Topical SprayPSN5d9f8ac1-cf42-4e30-bb3f-f59723f95b1a3
763484Dermoplast 20 % / 0.5 % Topical SprayPSN5d9f8ac1-cf42-4e30-bb3f-f59723f95b1a3
763484benzocaine 200 MG/ML / menthol 5 MG/ML Topical Spray [Dermoplast Pain]SBD5d9f8ac1-cf42-4e30-bb3f-f59723f95b1a3
199864benzocaine 200 MG/ML / menthol 5 MG/ML Topical SpraySCD5d9f8ac1-cf42-4e30-bb3f-f59723f95b1a3
199864benzocaine 20 % / menthol 0.5 % Topical SpraySY5d9f8ac1-cf42-4e30-bb3f-f59723f95b1a3
763484Dermoplast Insect Itch and Sting Relief (benzocaine 20 % / menthol 0.5 % ) Topical SpraySY5d9f8ac1-cf42-4e30-bb3f-f59723f95b1a3
763484Dermoplast Pain (benzocaine 20 % / menthol 0.5 % ) Topical SpraySY5d9f8ac1-cf42-4e30-bb3f-f59723f95b1a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16864-681-011686406810178 g in 1 CAN (16864-681-01) 78 g2021-05-150000-00-00NoNoCurrent