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		2026-10-15

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 52 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Large Medicate Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Amerisource Bergen	a7d5f89b-59b9-4603-99aa-273b85be813e	2025-12-22	Warnings	Exact identifier application number: M017
Good Neighbor Capsaicin Heat Patch for Back	CAPSAICIN	Amerisource Bergen	f873a0b8-8123-1600-e053-6394a90a043e	2025-12-22	Warnings	Exact identifier application number: M017
Good Neighbor Pharmacy Cold Therapy Pain Relief Patch	MENTHOL	Amerisource Bergen	f872f371-b92c-f5d5-e053-6294a90a7dcd	2025-12-22	Warnings	Exact identifier application number: M017
Caring Mills Hydrocortisone	HYDROCORTISONE	Veridian Healthcare	b0b1889b-3099-4943-a4cb-d9a898a06860	2025-12-22	Warnings	Exact identifier application number: M017
LIDOCAINE 5%	LIDOCAINE	Medhome Pharma Inc	46968f5a-d214-9871-e063-6394a90ab45d	2025-12-22	Warnings	Exact identifier application number: M017
Blue-Emu THRIVE Cooling	TRIPELENNAMINE 0.5%	Kingsway Pharmaceuticals dba NFI, LLC	7ac6456a-42c5-4ac8-aae6-db4abfda9df0	2025-12-22	Warnings	Exact identifier application number: M017
MENTHOL	MENTHOL	SUNSET PAIN RELIEF	45c5ca6f-d425-6cfb-e063-6394a90a1b66	2025-12-20	Warnings	Exact identifier application number: M017
HERSTAT GST Genital Sore Treatment	CAMPHOR, MENTHOL	Herstat (USA) Inc.	e8d27684-fb15-2e6a-e053-2a95a90a248f	2025-12-19	Warnings	Exact identifier application number: M017
Kroger Anti Itch	HYDROCORTISONE	The Kroger Co	46547277-f11a-b9e7-e063-6294a90a2ccd	2025-12-19	Warnings	Exact identifier application number: M017
Kroger Cool and Heat Roll-On	MENTHOL	Kroger	46551d07-3006-c3ec-e063-6294a90aa3f2	2025-12-19	Warnings	Exact identifier application number: M017
Naughty Kitty Kat	NO GAG DEEP THROAT SPRAY	INKED SUGAR, INC	170eb644-c72c-5744-e063-6394a90a767d	2025-12-19	Warnings	Exact identifier application number: M017
Tiger Balm Red Extra Strength	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	ce703715-4c11-472c-9270-daac87b7be05	2025-12-19	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Foot Pain Creme	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	da82cc0e-cc39-408e-87e1-c35bb6f9f51e	2025-12-19	Warnings	Exact identifier application number: M017
Health Trak Plus Menthol-Infused Pain Relief Socks	MENTHOL	Railroad Sock LLC	43413e55-1db2-fc1a-e063-6394a90a7167	2025-12-18	Warnings	Exact identifier application number: M017
BIO-ICE	MENTHOL, CAMPHOR	Electrostim Medical Services Inc. d/b/a EMSI	1bfd1468-9139-43b1-9709-d47b63d17cfb	2025-12-18	Warnings	Exact identifier application number: M017
Lidotrode	LIDOCAINE	Strand Health Group	1fd20b9a-b8bc-c94f-e063-6394a90a2b69	2025-12-18	Warnings	Exact identifier application number: M017
A Health Itch Relief Gel	ITCH RELIEF GEL	Bionpharma, Inc.	ecf5decb-c98b-7739-e053-2995a90a5541	2025-12-18	Warnings	Exact identifier application number: M017
After Burn	2.5% LIDOCAINE HCL	Tender Corporation d/b/a Adventure Ready Brands	4640395f-a76c-d022-e063-6294a90adde6	2025-12-18	Warnings	Exact identifier application number: M017
SPARTAN WIPES	ENDURANCE WIPES	TIV PRIME SRL	26d02431-2c95-001c-e063-6394a90a29c7	2025-12-18	Warnings	Exact identifier application number: M017
Stopain Extra Strength Continuous	MENTHOL	Troy Manufacturing, Inc.	a0f76968-d22c-4b1c-a9e6-8d0179a2e98e	2025-12-18	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