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 81 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE	HYDROCORTISONE	Click Industries LLC	328c389c-7e05-4892-a9b3-b6a753f4935a	2025-08-25	Warnings	Exact identifier application number: M017
Yeheal	CAMPHOR, MENTHOL, ISOPROPYL ALCOHOL	Shenzhen Yeheal Biotechnology Co., Ltd	3cf1bc74-3060-6d63-e063-6294a90a9f5c	2025-08-22	Warnings	Exact identifier application number: M017
Dermedial Anti-Ouch	MENTHOL	Natures Formulae Health Products Ltd.	3ce29160-3964-e435-e063-6394a90abb38	2025-08-21	Warnings	Exact identifier application number: M017
SUGARLOAF ORGANICS MENTHOL REVIVE	MENTHOL	RENU LABORATORIES, LLC	fa2f9539-b703-a00b-e053-6394a90ae309	2025-08-21	Warnings	Exact identifier application number: M017
Camphor 4% Plus Menthol 10%	CAMPHOR 4% PLUS MENTHOL 10%	PureTek Corporation	3cab26e4-e377-f26a-e063-6394a90a17af	2025-08-20	Warnings	Exact identifier application number: M017
Capsaicin 0.035% Cream	CAPSAICIN 0.035% CREAM	Puretekcorp	3cbc73b6-8c58-8f23-e063-6394a90a71a3	2025-08-20	Warnings	Exact identifier application number: M017
Game On	MENTHOL, METHYL SALICYLATE	Natural Essentials, Inc.	3cd20f1f-033f-f698-e063-6294a90a89eb	2025-08-20	Warnings	Exact identifier application number: M017
ELAIMEI Numbing Cream	LIDOCAINE 4%	Shenzhen Shandian Jingling Technology Co., Ltd.	37ac13b2-ca55-0e28-e063-6294a90a000e	2025-08-19	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	FSA Store Inc.	3cd18f96-34f7-3f2c-e063-6294a90a3b7e	2025-08-19	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE SPRAY	FSA Store Inc.	3ce24b87-55ac-0bbd-e063-6294a90ab582	2025-08-19	Warnings	Exact identifier application number: M017
Fast Freeze Pain Relieving	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	15a26af1-ca5a-40fc-a411-6c0e8ae18fbb	2025-08-18	Warnings	Exact identifier application number: M017
Orythia Maximum Strength Lidocaine Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	6d6b59f9-f614-4e3c-b07b-32b4591d39f2	2025-08-18	Warnings	Exact identifier application number: M017
Ocean Potion Suncare Ice Plus Pain Relieving Soothing	LIDOCAINE	GNL BRANDS INTERNATIONAL, LLC	3c69654c-cba6-dfef-e063-6394a90ad479	2025-08-15	Warnings	Exact identifier application number: M017
Earth Mama Medicated Herbal Lip Balm	MENTHOL	Eleeo Brands LLC	3c6c16bb-1f4b-b851-e063-6294a90a7404	2025-08-15	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Cintas First Aid & Safety	96f17095-31f3-4b8a-ab22-0caaefaa7476	2025-08-15	Warnings	Exact identifier application number: M017
MedPride Cold Ice Analgesic Gel	MENTHOL	SHIELD LINE LLC	860a2c86-b240-4e0e-e053-2a91aa0a333a	2025-08-15	Warnings	Exact identifier application number: M017
MedPride Medicated Body Powder Powder	MENTHOL, ZINC OXIDE	Shield Line LLC	cdb2fa5b-cf04-c876-e053-2a95a90a187c	2025-08-15	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE	HART Health	c5ff392a-e788-43e0-91ea-5e0f8420586c	2025-08-15	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	40df30ba-41ba-42b7-93fe-4183b57bdb00	2025-08-14	Warnings	Exact identifier application number: M017
Signature Care Aloe Vera Gel with Lidocaine	LIDOCAINE	Safeway, Inc.	d5069622-97b1-ba12-e053-2a95a90a7268	2025-08-14	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