FDA.reportPublic FDA data

Dermoplast Pain relieving

Product NDC
16864-690
11-digit product format
168640690
Labeler code
16864
Product ID
16864-690_0d12185e-8d41-7d76-e063-6294a90a2cf4
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE, MENTHOL
Dosage form
SPRAY
Route
TOPICAL
Labeler
Advantice Health
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-18
Substance
BENZOCAINE; MENTHOL
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

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
MENTHOL5 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
L7T10EIP3AInternal 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
dad00c95-4e11-3eec-e053-2a95a90a7a18Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-690-01Dermoplast Pain relieving78 g in 1 CANSPRAY782

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-690DERMOPLAST PAIN RELIEVING (BENZOCAINE, MENTHOL) SPRAY [ADVANTICE HEALTH]2Current NDC, Legacy NDC, 1 package rows20231222_dad00c95-4e11-3eec-e053-2a95a90a7a18.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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
application number: M017
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
application number: M017
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199864benzocaine 20 % / menthol 0.5 % Topical SprayPSNdad00c95-4e11-3eec-e053-2a95a90a7a182
763484Dermoplast 20 % / 0.5 % Topical SprayPSNdad00c95-4e11-3eec-e053-2a95a90a7a182
763484benzocaine 200 MG/ML / menthol 5 MG/ML Topical Spray [Dermoplast Pain]SBDdad00c95-4e11-3eec-e053-2a95a90a7a182
199864benzocaine 200 MG/ML / menthol 5 MG/ML Topical SpraySCDdad00c95-4e11-3eec-e053-2a95a90a7a182
199864benzocaine 20 % / menthol 0.5 % Topical SpraySYdad00c95-4e11-3eec-e053-2a95a90a7a182
763484Dermoplast Insect Itch and Sting Relief (benzocaine 20 % / menthol 0.5 % ) Topical SpraySYdad00c95-4e11-3eec-e053-2a95a90a7a182
763484Dermoplast Pain (benzocaine 20 % / menthol 0.5 % ) Topical SpraySYdad00c95-4e11-3eec-e053-2a95a90a7a182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16864-690-011686406900178 g in 1 CAN (16864-690-01) 78 g2022-03-180000-00-00NoNoCurrent