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 16 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Ice Extreme Dry StickMENTHOLCarlin Consumer Health LLC4f81be91-92e5-1205-e063-6394a90a6e822026-06-02WarningsExact identifier
application number: M017
Kalaya Extra Strength Pain Relief Gel with ArnicaMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpb6a6237d-b471-4102-b5df-fc389f5f92582026-06-02WarningsExact identifier
application number: M017
Biofreeze UltraflexLIDOCAINEReckitt Benckiser LLC2655974b-a67d-9f07-e063-6294a90a54e82026-06-02WarningsExact identifier
application number: M017
Biofreeze Ultraflex PlusLIDOCAINE, MENTHOLReckitt Benckiser LLC401e1843-e9a6-fda9-e063-6294a90a30732026-06-02WarningsExact identifier
application number: M017
Pain ReliefMENTHOL SPRAYOwell Naturals Brand, LLC534c871c-da35-6135-e063-6294a90aa9f62026-06-02WarningsExact identifier
application number: M017
Charm Tex FLUORIDE GelSODIUM FLUORIDEJiangsu Gold Worldworks Household Chemicals Co., Ltd.09d47bd7-1438-4ef2-85e0-9cd5eb2f763a2026-05-31WarningsExact identifier
application number: M017
Charm Tex FLUORIDESODIUM MONOFLUOROPHOSPHATEJiangsu Gold Worldworks Household Chemicals Co., Ltd.2bddc69a-0c0f-47fc-bc98-90c2ec70dd6f2026-05-31WarningsExact identifier
application number: M017
Sting Relief Prep PadBENZOCAINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.9487d15d-9116-4ff8-a004-ba0835ea091e2026-05-31WarningsExact identifier
application number: M017
Careland Kinesiology Pain Relieving TapeCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.35d24cfc-9d34-4fd7-9312-1673b092a3b92026-05-31WarningsExact identifier
application number: M017
Walgreens Scalp Itch ReliefHYDROCORTISONEWalgreens34952272-1f9e-c642-e063-6394a90ae2bd2026-05-29WarningsExact identifier
application number: M017
Aspercreme with Lidocaine No-Mess ApplicatorLIDOCAINE HYDROCHLORIDEChattem, Inc.8092cde7-28d0-4755-b5c0-5765934e572f2026-05-29WarningsExact identifier
application number: M017
Belladona and ArnicaMENTHOLDannso Corp./d.b.a. Essential Productsfc4e63e4-cebc-49ff-8900-7238261d0fe02026-05-28WarningsExact identifier
application number: M017
Insect Sting ReliefBENZOCAINE, ALCOHOLHubei Fanjian Medical Product Co.,Ltdf30401c1-961e-44dd-e053-2a95a90a69d62026-05-28WarningsExact identifier
application number: M017
Menthol plus Camphor Pain ReliefMENTHOL, CAMPHORVeridian Healthcare4a054949-0889-7182-e063-6394a90aff5e2026-05-28WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECVS Pharmacy960bfe55-87f6-3e51-e053-2995a90a867d2026-05-27WarningsExact identifier
application number: M017
MyDerm Medical 5 Lidocaine Numbing Roll-OnLIDOCAINEInspec Solutions1d466be1-a780-462f-8dd4-87478da096aa2026-05-27WarningsExact identifier
application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More MentholMENTHOLInspec Solutions LLC.d427d623-c2fd-7d6b-e053-2995a90abdc32026-05-27WarningsExact identifier
application number: M017
Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEAmerisource Bergend8802e56-649e-4494-86ee-7ca8841cc28b2026-05-27WarningsExact identifier
application number: M017
Equate Itch Relief GelITCH RELIEF GELWalmart, Inc7d7bb750-017e-c60e-e053-2991aa0ad6712026-05-26WarningsExact identifier
application number: M017
MyDerm Bite and StingBENZOCAINEMedline Industriesbf45c4dd-5814-4602-b96b-f82a449487632026-05-26WarningsExact 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