Dermoplast Insect Itch and Sting Relief

Product NDC: 16864-682
11-digit product format: 168640682
Labeler code: 16864
Product ID: 16864-682_62e741d9-46d7-4762-8b00-570e86c20385
Type: HUMAN OTC DRUG
Nonproprietary name: BENZOCAINE and LEVOMENTHOL
Dosage form: SPRAY
Route: TOPICAL
Labeler: Advantice Health, LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-05-15
Marketing end: 0000-00-00
Substance: BENZOCAINE; LEVOMENTHOL
Active strength: 200 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	16864-682		D	Discontinued by firm		2026-10-05
excluded package	package	16864-682	16864-682-01	D	Discontinued by firm		2026-10-05

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16864-682-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16864-682-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16864-682-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16864-682-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16864-682-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16864-682-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16864-682-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16864-682-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16864-682-01	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16864-682-01	Dermoplast Insect Itch and Sting Relief	78 g in 1 CAN	SPRAY	78		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16864-682	DERMOPLAST INSECT ITCH AND STING RELIEF (BENZOCAINE AND LEVOMENTHOL) SPRAY [ADVANTICE HEALTH, LLC]	3	Legacy NDC, 1 package rows	20241215_d9082386-7127-4a4a-bd47-1cab2954d424.zip

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	d9082386-7127-4a4a-bd47-1cab2954d424	3
763484	Dermoplast 20 % / 0.5 % Topical Spray	PSN	d9082386-7127-4a4a-bd47-1cab2954d424	3
763484	benzocaine 200 MG/ML / menthol 5 MG/ML Topical Spray [Dermoplast Pain]	SBD	d9082386-7127-4a4a-bd47-1cab2954d424	3
199864	benzocaine 200 MG/ML / menthol 5 MG/ML Topical Spray	SCD	d9082386-7127-4a4a-bd47-1cab2954d424	3
199864	benzocaine 20 % / menthol 0.5 % Topical Spray	SY	d9082386-7127-4a4a-bd47-1cab2954d424	3
763484	Dermoplast Insect Itch and Sting Relief (benzocaine 20 % / menthol 0.5 % ) Topical Spray	SY	d9082386-7127-4a4a-bd47-1cab2954d424	3
763484	Dermoplast Pain (benzocaine 20 % / menthol 0.5 % ) Topical Spray	SY	d9082386-7127-4a4a-bd47-1cab2954d424	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16864-682-01	16864068201	78 g in 1 CAN (16864-682-01)	78 g	2021-05-15	0000-00-00	No	No	Current