FDA.reportPublic FDA data

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

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 packagepackage16864-68016864-680-02DDiscontinued by firm2026-10-15

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…

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
IngredientStrength
BENZOCAINE200 mg/g
LEVOMENTHOL5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
BZ1R15MTK7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199864Internal RxNorm lookup
763484Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2347f0b8-d463-422d-8583-65624d9a1a91Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-680-01Dermoplast Pain Relieving78 g in 1 CANSPRAY786
16864-680-02Dermoplast Pain Relieving56 g in 1 CANSPRAY566
16864-680-03Dermoplast Pain Relieving85 g in 1 CANSPRAY856

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16864-680-01GM - Gram16864-680a08daaef-1dde-4012-a9e3-a360604b898612019-08-06
16864-680-02GM - Gram16864-6807551ef66-3912-4ce9-8e29-f3781485b70312019-08-06
16864-680-03GM - Gram16864-680c136f816-0197-44f7-830f-407c01dedd9212021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-680DERMOPLAST PAIN RELIEVING (BENZOCAINE AND LEVOMENTHOL) SPRAY [ADVANTICE HEALTH, LLC]6Current NDC, Legacy NDC, 3 package rows20241215_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 66 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCORTISONEHYDROCORTISONEEncube Ethicals, Inc.969cd576-82d3-4662-bbc1-3587a1f6a5642025-11-10WarningsExact identifier
application number: M017
Jelcaine SterileLIDOCAINE HCL JELLY USP, 2%Brookfield Pharmaceuticals, LLC1a39d1de-7aa2-3068-e063-6394a90aed852025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anestheticc6e86a0f-6f9b-45b7-86ce-0bb1c198061a2025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anesthetic97ae1993-7268-4b7f-92e2-6004337d56502025-11-10WarningsExact identifier
application number: M017
MENTHOL AND METHYL SALICYLATEELECTRIC MEDICATED BALM ULTRA STRENGTHFEI FAH MEDICAL MANUFACTURING PTE LTD91e6d3b9-25bb-4015-9d96-bd27f93e5ada2025-11-10WarningsExact identifier
application number: M017
E MEI SHAN MEDICATEDCAMPHOR, MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltdbda1e7c1-42df-4126-a512-80f843b07fd02025-11-10WarningsExact identifier
application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVINGCAMPHOR AND MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltd9850754b-ac94-4ec6-b75a-8096e5ac94562025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
TONG FENG DING PAIN RELIEFCAMPHOR AND MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltdfe87b864-b3ee-4a4b-8e5a-e1ee6493de0d2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC5ef90782-8201-47d1-b57f-f032d4c9b06a2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC1388ab3a-c26f-427d-898d-0d88411a5fba2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Capsaicin Patch HotCAPSAICINMADISON ONE ACME INCf74db6e0-853a-4eb3-a4b5-9da2cd3d95cf2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Lung Choy Shung Pain Relief LiquidMENTHOL AND CAMPHORMADISON ONE ACME INC4842c6ec-7823-4f6b-afc4-258fce2c23912025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
701 DIEDA ZHENGTONG YAOGAO MEDICATEDCAMPHOR AND MENTHOLMADISON ONE ACME INC115041ff-5046-4ca4-b54b-5652037e74bd2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEFCAMPHOR AND MENTHOLMADISON ONE ACME INC0f269a41-4b56-4e22-b9cb-17d99bf76a572025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
ZANG HONG HUA PAIN RELIEVINGCAMPHOR, CAPSAICIN, AND METHYL SALICYLATEMADISON ONE ACME INCe0a8811c-07cf-4dee-a0e5-13b8af1b27b62025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
NECK AND LUMBAR PAIN RELIEVING BALMCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INCd06f0650-a5f6-4bc1-a70b-b0fc16968fa92025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
SHU JIN HUO LUO PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INCccb6740d-3399-4a2b-ae65-15ca557ba83b2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
GuruNanda Pain ReliefLIDOCAINE HYDROCHLORIDEGuruNanda, LLC.3ab6a133-8dca-e14e-e063-6394a90a85e72025-11-10WarningsExact identifier
application number: M017
HUO LUO PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC65581716-5a2c-4ee8-816d-00caed7b95b42025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
JOSEPHS LION PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199864benzocaine 20 % / menthol 0.5 % Topical SprayPSN2347f0b8-d463-422d-8583-65624d9a1a916
763484Dermoplast 20 % / 0.5 % Topical SprayPSN2347f0b8-d463-422d-8583-65624d9a1a916
763484benzocaine 200 MG/ML / menthol 5 MG/ML Topical Spray [Dermoplast Pain]SBD2347f0b8-d463-422d-8583-65624d9a1a916
199864benzocaine 200 MG/ML / menthol 5 MG/ML Topical SpraySCD2347f0b8-d463-422d-8583-65624d9a1a916
199864benzocaine 20 % / menthol 0.5 % Topical SpraySY2347f0b8-d463-422d-8583-65624d9a1a916
763484Dermoplast Insect Itch and Sting Relief (benzocaine 20 % / menthol 0.5 % ) Topical SpraySY2347f0b8-d463-422d-8583-65624d9a1a916
763484Dermoplast Pain (benzocaine 20 % / menthol 0.5 % ) Topical SpraySY2347f0b8-d463-422d-8583-65624d9a1a916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16864-680-011686406800178 g in 1 CAN (16864-680-01) 78 g2014-01-010000-00-00NoNoCurrent
16864-680-021686406800256 g in 1 CAN (16864-680-02) 56 g2014-01-010000-00-00NoNoCurrent
16864-680-031686406800385 g in 1 CAN (16864-680-03) 85 g2014-01-010000-00-00NoNoCurrent