PROHEAL BURN

Product NDC: 43473-066
11-digit product format: 434730066
Labeler code: 43473
Product ID: 43473-066_2c1c5ff5-197c-bd17-e063-6394a90a19bc
Type: HUMAN OTC DRUG
Nonproprietary name: LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Nantong Health & Beyond Hygienic Products Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-01-17
Substance: LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength: .5; .13 g/100g; g/100g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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: PROHEAL BURN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	.5 g/100g
BENZALKONIUM CHLORIDE	.13 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	Internal UNII lookup
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1012100	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
bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43473-066-01	PROHEAL BURN	0.9 g in 1 PACKET	CREAM	0.9		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43473-066	PROHEAL BURN (LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE) CREAM [NANTONG HEALTH & BEYOND HYGIENIC PRODUCTS INC.]	1	Current NDC, 1 package rows	20250121_bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab1.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 79 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KNEE PAIN RELIRF Patch	CAMPHOR, MENTHOL	Shenzhen Finona Information Technology Co., Ltd	3db971ef-d7fa-0171-e063-6294a90aa58b	2025-09-01	Warnings	Exact identifier application number: M017
Bikini Zone Medicated Creme	LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	300ac57e-844a-4840-b285-41ff5518e6b6	2025-08-29	Warnings	Exact identifier application number: M017
Bikini Zone Medicated Gel	LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	30b85890-e72d-4af7-bda9-e7744abc92af	2025-08-29	Warnings	Exact identifier application number: M017
Sumifun Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3d7dc8cc-0680-d94d-e063-6394a90ac8e8	2025-08-29	Warnings	Exact identifier application number: M017
TKTALKER NUMBING	NUMBING	Shenzhen Shandian Jingling Technology Co., Ltd.	3d7e6757-f183-2a68-e063-6294a90ae4ca	2025-08-29	Warnings	Exact identifier application number: M017
PBZ OTC	TRIPELENNAMINE HCL 1%	Kingsway Pharmaceuticals dba NFI, LLC	12f72d74-018f-4bc6-acd4-175ca3af4c6d	2025-08-29	Warnings	Exact identifier application number: M017
else.	LIDOCAINE	Else Co.	3d6c7b10-ed03-bbde-e063-6294a90ae92f	2025-08-28	Warnings	Exact identifier application number: M017
Mountain Ice Pain Relief	MENTHOL	Mountainside Medical Equipment, Inc.	c79fdd91-16f4-4ae0-bee4-d37c05ed2074	2025-08-28	Warnings	Exact identifier application number: M017
HealthWise 4% Lidocaine Cream 2.7 oz	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	f39eb3d0-e153-4f50-85b1-ad5c677d176c	2025-08-28	Warnings	Exact identifier application number: M017
HealthWise Overnight Menthol Patch	MENTHOL	Veridian Healthcare	6379f50d-2878-46ca-8acb-71c4554585e9	2025-08-28	Warnings	Exact identifier application number: M017
Anti Itch Maximum Relief	PRAMOXINE HYDROCHLORIDE AND MENTHOL	Natureplex LLC	75de3d5e-ecbe-4d04-a39d-792200e6ee32	2025-08-28	Warnings	Exact identifier application number: M017
NicDuic Quit Smoking Nicotine Patches	NICOTINE TRANSDERMAL PATCHES	Shenzhen Paxi Trading Co., Ltd.	3d5718f3-c175-6b64-e063-6394a90aa6f1	2025-08-27	Warnings	Exact identifier application number: M017
ARCTIC HEAT	MENTHOL, METHYL SALICYLATE	Renu Laboratories, LLC	402df5c1-b8cb-17a2-e054-00144ff8d46c	2025-08-27	Warnings	Exact identifier application number: M017
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1012100	benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream	PSN	bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab1	1
1012100	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream	SCD	bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab1	1
1012100	benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream	SY	bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
43473-066-01	43473006601	.9 g in 1 PACKET (43473-066-01)	2025-01-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
43473-066 PROHEAL burn cream	Nantong Health & Beyond Hygienic Products Inc.	2025-01-19	HUMAN OTC DRUG LABEL	1