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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16864-680	16864-680-02	D	Discontinued by firm		2026-10-16

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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`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
Ingredient	Strength
BENZOCAINE	200 mg/g
LEVOMENTHOL	5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup
BZ1R15MTK7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2347f0b8-d463-422d-8583-65624d9a1a91	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16864-680-01	Dermoplast Pain Relieving	78 g in 1 CAN	SPRAY	78	6
16864-680-02	Dermoplast Pain Relieving	56 g in 1 CAN	SPRAY	56	6
16864-680-03	Dermoplast Pain Relieving	85 g in 1 CAN	SPRAY	85	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16864-680-01	GM - Gram	16864-680	a08daaef-1dde-4012-a9e3-a360604b8986	1	2019-08-06
16864-680-02	GM - Gram	16864-680	7551ef66-3912-4ce9-8e29-f3781485b703	1	2019-08-06
16864-680-03	GM - Gram	16864-680	c136f816-0197-44f7-830f-407c01dedd92	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16864-680	DERMOPLAST PAIN RELIEVING (BENZOCAINE AND LEVOMENTHOL) SPRAY [ADVANTICE HEALTH, LLC]	6	Current NDC, Legacy NDC, 3 package rows	20241215_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 101 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menthol Pain Relief Gel-Roll On	MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	0bd62de8-ce8b-c110-e063-6294a90a98cb	2025-02-07	Warnings	Exact identifier application number: M017
Menthol Pain Relief Gel-Tube	MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	0bb07892-824e-8691-e063-6294a90a3891	2025-02-07	Warnings	Exact identifier application number: M017
Olu Pain Management	LIDOCAINE AND CAMPHOR	Olakino Therapeutics LLC	2a41a621-c6f7-5819-e063-6394a90ae67d	2025-02-07	Warnings	Exact identifier application number: M017
Pain Reliveing Patch	LIDOCAINE 4%	simple diagnostics	02ed0b27-bba9-ec0c-e063-6294a90a014d	2025-02-07	Warnings	Exact identifier application number: M017
FlexDermal Pain Relieving Roll-On	MENTHOL	SOLVADERM LLC	d4d8050e-0761-4491-8635-39c806701eb5	2025-02-06	Warnings	Exact identifier application number: M017
Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine	LIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINE	Clarion Brands LLC	2d7e9f6a-0f21-b103-e063-6294a90a912f	2025-02-06	Warnings	Exact identifier application number: M017
signature care Hydrocortisone	HYDROCORTISONE	Safeway	9fe16fc5-77e3-47f5-a943-85bc6565c0d4	2025-02-06	Warnings	Exact identifier application number: M017
Methyl Salicylate	METHYL SALICYLATE	PHARMACURE LLC	8803ae01-ea48-46c2-ab64-bb273de605ac	2025-02-05	Warnings	Exact identifier application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate	TROLAMINE SALICYLATE	TELEBRANDS CORP	2d685602-5cd6-3b36-e063-6394a90a3c5d	2025-02-05	Warnings	Exact identifier application number: M017
Lidocore	LIDOCAINE	iON Pharma, LLC	204c3e50-1ac8-f442-e063-6294a90ae7b5	2025-02-05	Warnings	Exact identifier application number: M017
Methyl Salicylate	METHYL SALICYLATE	PHARMACURE LLC	2c32cfed-2022-4e7c-ae9c-ba22dbb560af	2025-02-04	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	PHARMACURE LLC	b2b2de93-d957-43d7-a2a8-b46bcaea1f0d	2025-02-04	Warnings	Exact identifier application number: M017
Hempvana Maximum Strength Pain Relief Cream Extreme	MENTHOL 16%, CAMPHOR 11%	Telebrands Corp	2d54077e-4c8d-aaae-e063-6394a90adb41	2025-02-04	Warnings	Exact identifier application number: M017
Capsaicin External Analgesic	CAPSAICIN	NuCare Pharmaceuticals,Inc.	fd90a67d-d60d-a849-e053-6394a90a2cc8	2025-02-04	Warnings	Exact identifier application number: M017
Rugby Muscle Rub Cream	MUSCLE RUB CREAM	NuCare Pharmaceuticals, Inc.	2d58c15a-5ddb-1b16-e063-6294a90a3fbb	2025-02-04	Warnings	Exact identifier application number: M017
Cetilar	MENTHOL 1.4%	PharmaNutra Usa Corp.	2dd14bd4-b4e1-bc7d-e063-6394a90a1e59	2025-02-04	Warnings	Exact identifier application number: M017
Stopain Extra Strength Continuous	MENTHOL	Troy Manufacturing, Inc.	0d199d39-5b47-4c7f-b83a-757f39aa17b6	2025-02-03	Warnings	Exact identifier application number: M017
TheraCare Pain Relieving Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	2d42192b-8889-a896-e063-6294a90a4fc8	2025-02-03	Warnings	Exact identifier application number: M017
Tiger Balm Pain Relieving Muscle	METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)	Haw Par Healthcare Ltd.	96b06d3f-8685-4314-ad7d-5d2720f4dde6	2025-02-03	Warnings	Exact identifier application number: M017
Icy Hot Medicated No Mess Applicator	MENTHOL	Chattem, Inc.	4ce2b823-7ef5-4cca-a2d8-2fe781bc958e	2025-02-01	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE
BZ1R15MTK7	LEVOMENTHOL	2216-51-5	LEVOMENTHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199864	benzocaine 20 % / menthol 0.5 % Topical Spray	PSN	2347f0b8-d463-422d-8583-65624d9a1a91	6
763484	Dermoplast 20 % / 0.5 % Topical Spray	PSN	2347f0b8-d463-422d-8583-65624d9a1a91	6
763484	benzocaine 200 MG/ML / menthol 5 MG/ML Topical Spray [Dermoplast Pain]	SBD	2347f0b8-d463-422d-8583-65624d9a1a91	6
199864	benzocaine 200 MG/ML / menthol 5 MG/ML Topical Spray	SCD	2347f0b8-d463-422d-8583-65624d9a1a91	6
199864	benzocaine 20 % / menthol 0.5 % Topical Spray	SY	2347f0b8-d463-422d-8583-65624d9a1a91	6
763484	Dermoplast Insect Itch and Sting Relief (benzocaine 20 % / menthol 0.5 % ) Topical Spray	SY	2347f0b8-d463-422d-8583-65624d9a1a91	6
763484	Dermoplast Pain (benzocaine 20 % / menthol 0.5 % ) Topical Spray	SY	2347f0b8-d463-422d-8583-65624d9a1a91	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16864-680-01	16864068001	78 g in 1 CAN (16864-680-01)	78 g	2014-01-01	0000-00-00	No	No	Current
16864-680-02	16864068002	56 g in 1 CAN (16864-680-02)	56 g	2014-01-01	0000-00-00	No	No	Current
16864-680-03	16864068003	85 g in 1 CAN (16864-680-03)	85 g	2014-01-01	0000-00-00	No	No	Current