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 136 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Capsaicin External AnalgesicCAPSAICINProficient Rx LP7c733a30-5002-49e7-a6bd-7737a1d2461e2024-02-01WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEProficient Rx LPccb62898-b614-45b9-95ea-23e5e31893a82024-02-01WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONEProficient Rx LP0b26d92f-9d0e-46d4-a8bc-75d6da5f61992024-02-01WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEProficient Rx LPc57d5f8e-5934-4cbb-999a-cdd55e5b105f2024-02-01WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEProficient Rx LP47e9fe84-bd0c-40ea-85de-e950bcacc5572024-02-01WarningsExact identifier
application number: M017
Joint and Muscle PainMENTHOLShaklee Corporation3943824f-1f4f-4d6f-bd73-0b1be02162a52024-01-30WarningsExact identifier
application number: M017
Mirakel Pain Relief Roll-OnLIDOCAINE HCLSanvio, Inc.102f3618-13ad-37e3-e063-6294a90a80862024-01-30WarningsExact identifier
application number: M017
Blistex Lip MedexPETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOLBlistex Inc.8ad39005-9419-4f1a-a1ae-2f76d212455e2024-01-26WarningsExact identifier
application number: M017
Point Relief Cold Spot Pain RelievingMENTHOLFabrication Enterprisesad5d6f04-15e6-4548-95c2-32271c186bc12024-01-25WarningsExact identifier
application number: M017
MIND BODY MATRIX PAIN RELIEFMENTHOLFunctional Energetic, Inc.3667dd0d-942e-4101-ba98-cb013ae77cf52024-01-25WarningsExact identifier
application number: M017
SUPER WHITE STUFF Pain ReliefMENTHOLBLUE SPRING WELLNESSe6d27df5-118c-4c6d-86e8-7b4401a39c762024-01-23WarningsExact identifier
application number: M017
Burn First AidBURN FIRST AIDDynarex Corporation826e08be-dffa-5a27-e053-2a91aa0a87012024-01-22WarningsExact identifier
application number: M017
Target Up and Up Pain Relief Menthol Topical Analgesic Roll-OnMENTHOLTARGET CORPORATION0f95fc55-8665-9e89-e063-6394a90a78912024-01-22WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain Relief Plus MentholLIDOCAINE, MENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.77978069-a1b4-473e-83c9-8320e00eea892024-01-19WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPSCAMPHOR, MENTHOLKOBAYASHI Healthcare International, Inc.ba26635d-95d3-4d88-93cc-1fd4fd29fd792024-01-18WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthe95ebdac-9789-41c2-97da-2307e45387942024-01-18WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATEUnifirst First Aid Corporationbd216f5d-f304-7d8d-e053-2a95a90aa9ce2024-01-17WarningsExact identifier
application number: M017
Green Guard Hydrocortisone 1%HYDROCORTISONEUnifirst First Aid Corporationbd348e2a-57b1-3f17-e053-2a95a90a8bdc2024-01-17WarningsExact identifier
application number: M017
Pain ReliefLIDOCAINE, MENTHOLHUMN Pharmaceuticals Inc6c96f94a-e724-eab3-e053-2991aa0aab882024-01-17WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain ReliefLIDOCAINENatural Essentials, Inc.52e82e70-53b7-4ecb-be39-fe10c94cc4442024-01-17WarningsExact 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