NeuroMed

Product NDC: 54723-722
11-digit product format: 547230722
Labeler code: 54723
Product ID: 54723-722_436cb44e-7216-9840-e063-6394a90ae137
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: CREAM
Route: TOPICAL
Labeler: Sambria Pharmaceuticals, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-08-21
Substance: BENZOCAINE
Active strength: 20 mg/100mg
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

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54723-722-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54723-722-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54723-722-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54723-722-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54723-722-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54723-722-05	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54723-722-05	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54723-722-05	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	54723-722-03	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	54723-722-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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: NeuroMed
Brand name suffix: FA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	20 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
723562	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
97345ed4-51c3-4221-852c-2cd563f33317	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54723-722-05	2025-01-30	C162847	48780-1	2cef2736-7a78-d83d-e063-dadaa90ab31f	NeuroMed FA Topical Analgesic
54723-722-05	2025-01-30	C162847	48780-1	2cef2736-7a78-d83d-e063-dadaa90ab31f	NeuroMed FA Topical Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54723-722-03	NeuroMedFA	3000 mg in 1 PACKET	CREAM	3000	11
54723-722-04	NeuroMedFA	1500 mg in 1 PACKET	CREAM	1500	11
54723-722-05	NeuroMedFA	5000 mg in 1 PACKET	CREAM	5000	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54723-722	NEUROMED FA (BENZOCAINE) CREAM [SAMBRIA PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20240906_605fc242-ad31-4aa9-bd86-fba4ddf0d305.zip
54723-722	NEUROMED FA (BENZOCAINE) CREAM [SAMBRIA PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20231202_97345ed4-51c3-4221-852c-2cd563f33317.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 104 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANTI ITCH	HYDROCORTISONE	Safeway	0bfa1653-76b7-48ed-a896-a0b5fc3bd794	2025-01-08	Warnings	Exact identifier application number: M017
Sting Relief Swab	BENZOCAINE	Epic Medical Supply Corp	259fbfe4-d67c-ea1e-e063-6294a90a0fb0	2025-01-07	Warnings	Exact identifier application number: M017
Sinsin Mulpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	22ea8a51-fdee-4650-abf8-f996268c9303	2025-01-07	Warnings	Exact identifier application number: M017
SINSINPAP COOL	LEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUS	Sinsin Pharmaceutical Co., Ltd.	9d47855f-ccb5-4557-a31a-a2b336fa9806	2025-01-07	Warnings	Exact identifier application number: M017
Burn Jel	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	ff621b46-2342-41db-994d-851a09796d08	2025-01-06	Warnings	Exact identifier application number: M017
Lidocare Arm, Neck, Leg	4% LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	59a104ee-7034-99c3-e053-2991aa0a164c	2025-01-06	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE Pain Relieving	LIDOCAINE	Hisamitsu Pharmaceutical Co., Inc.	4f3a438c-f378-4d2a-a95c-58e56cf1e797	2025-01-06	Warnings	Exact identifier application number: M017
Lidocare 03	4% LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	416ebf5a-2efb-6d0b-e054-00144ff88e88	2025-01-06	Warnings	Exact identifier application number: M017
AVCOO Pain Relief Roll-on	MENTHOL	ADP Health Limited	e0bb77b2-45ee-45fa-9659-9c7d99bb20dc	2025-01-05	Warnings	Exact identifier application number: M017
health and beyond BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	0b6bb3ed-50fb-40c4-acb6-ae3f16031531	2025-01-05	Warnings	Exact identifier application number: M017
glo SKIN BEAUTY Remedy Gel	GLO SKIN BEAUTY REMEDY GEL	Hayden Caleel LLC	aa47ff08-07b3-4fd1-bae5-420e4b928f06	2025-01-05	Warnings	Exact identifier application number: M017
Capsaicin 0.025% Cream	CAPSAICIN 0.025%	Puretek Corporation	28f00df0-c416-f17b-e063-6294a90a5570	2025-01-02	Warnings	Exact identifier application number: M017
AVON HeXashield Pain Relief for Muscle, Back and Joint Cream	CAMPHOR, MENTHOL, METHYL SALICYLATE	Tai Guk Pharm. Co., Ltd.	8f29ffd7-48b9-109f-e053-2995a90ab215	2025-01-01	Warnings	Exact identifier application number: M017
AVON HeXashield Arthritis Pain Relief Cream Capsaisin	CAPSAISIN	Tai Guk Pharm. Co., Ltd.	8f286a9d-8765-21b3-e053-2a95a90ae43a	2025-01-01	Warnings	Exact identifier application number: M017
AVON HeXashield Anti Itch Cream with Healing Aloe	HYDROCORTISONE	Tai Guk Pharm. Co., Ltd.	8f2aa11d-d794-6f3e-e053-2995a90a1d9d	2025-01-01	Warnings	Exact identifier application number: M017
HeXashield Anti Itch Cream with Healing Aloe	HYDROCORTISONE	Tai Guk Pharm. Co., Ltd.	b9d033f3-4d12-a2c8-e053-2995a90ac7f1	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Pain Relief with Menthol	MENTHOL	Green Compass, Inc.	0a0c212e-ae5d-8505-e063-6394a90af622	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	0a0b688e-50f1-3eb1-e063-6394a90a7efa	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Topical Pain	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	8cb80362-5d24-1ee3-e053-2a95a90afcdf	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Roll-On Pain Relief	MENTHOL	Green Compass, Inc.	b5916aa2-428c-5637-e053-2995a90a08b0	2025-01-01	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
723562	benzocaine 20 % Topical Cream	PSN	605fc242-ad31-4aa9-bd86-fba4ddf0d305	11
723562	benzocaine 200 MG/ML Topical Cream	SCD	605fc242-ad31-4aa9-bd86-fba4ddf0d305	11
723562	benzocaine 20 % Topical Cream	SY	605fc242-ad31-4aa9-bd86-fba4ddf0d305	11
723562	benzocaine 20 % Topical Cream	PSN	97345ed4-51c3-4221-852c-2cd563f33317	8
723562	benzocaine 200 MG/ML Topical Cream	SCD	97345ed4-51c3-4221-852c-2cd563f33317	8
723562	benzocaine 20 % Topical Cream	SY	97345ed4-51c3-4221-852c-2cd563f33317	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54723-722-03	54723072203	3000 mg in 1 PACKET (54723-722-03)	3000 mg	2016-02-01	0000-00-00	No	No	Current
54723-722-04	54723072204	1500 mg in 1 PACKET (54723-722-04)	1500 mg	2024-07-29		No	No	Current
54723-722-05	54723072205	5000 mg in 1 PACKET (54723-722-05)	5000 mg	2017-08-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NeuroMed FA Topical Analgesic	Sambria Pharmaceuticals, Inc. \| Southeast Holdings Corp	2025-11-12	HUMAN OTC DRUG LABEL	11
NeuroMed FA Topical Analgesic	Sambria Pharmaceuticals, Inc. \| Southeast Holdings Corp	2025-11-12	HUMAN OTC DRUG LABEL	8