NeuroMed

Product NDC
54723-722
Requested package NDC
54723-722-03
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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54723-72254723-722-03EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Additional Listing Data#

Finished product
Yes
Brand name base
NeuroMed
Brand name suffix
FA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
723562Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
97345ed4-51c3-4221-852c-2cd563f33317Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54723-722-052025-01-30C16284748780-12cef2736-7a78-d83d-e063-dadaa90ab31fNeuroMed FA Topical Analgesic
54723-722-052025-01-30C16284748780-12cef2736-7a78-d83d-e063-dadaa90ab31fNeuroMed FA Topical Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54723-722-03NeuroMedFA3000 mg in 1 PACKETCREAM300011
54723-722-04NeuroMedFA1500 mg in 1 PACKETCREAM150011
54723-722-05NeuroMedFA5000 mg in 1 PACKETCREAM50008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54723-722NEUROMED FA (BENZOCAINE) CREAM [SAMBRIA PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20240906_605fc242-ad31-4aa9-bd86-fba4ddf0d305.zip
54723-722NEUROMED FA (BENZOCAINE) CREAM [SAMBRIA PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20231202_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 1 of 153 · 3,056 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMENTHOLChattem, Inc.aa40c907-eeb5-4fda-b35e-439cbecc178c2026-07-31WarningsExact identifier
application number: M017
Aspercreme with Lidocaine DryLIDOCAINEChattem, Inc.008abaaa-5e12-4246-a7f5-66f3966acf282026-07-30WarningsExact identifier
application number: M017
Icy Hot Performance No-Mess Pain Relief CreamMENTHOL 16%, CAMPHOR 11%Chattem, Inc.5e3e272a-c001-4f57-9535-521ccc85ae652026-07-30WarningsExact identifier
application number: M017
Auixudin Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.57bc7b9e-e2f7-724b-e063-6394a90ab36f2026-07-29WarningsExact identifier
application number: M017
Jinfahe Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.57bcd9c5-767e-b634-e063-6394a90a28782026-07-29WarningsExact identifier
application number: M017
Maximun Strength Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLMeijer Distribution Incd0468514-58ea-4d8f-b634-a65bf95c03162026-07-29WarningsExact identifier
application number: M017
Oudetas Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.57ca9220-2778-790a-e063-6294a90af5062026-07-29WarningsExact identifier
application number: M017
Aspercreme Lidocaine No-Mess plus LavenderLIDOCAINE HCLChattem, Inc.3948a3d2-ce04-4703-8709-211e75c9c38d2026-07-29WarningsExact identifier
application number: M017
LidoProLIDOCAINE AND MENTHOLClinic Pharmacdfd6b39-b430-4e95-a0f7-682cf3d78b522026-07-28WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHClinic Pharma2b4d2105-b7ad-2695-e063-6394a90a999b2026-07-28WarningsExact identifier
application number: M017
Earths Care Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEDLC Laboratories, Inc.5c3976da-a6cb-4b94-ae41-3e86b1ab13cb2026-07-28WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Preferred Pharmaceuticals Inc.9e7568b6-52ae-4f7a-9bfd-503fd80a297e2026-07-28WarningsExact identifier
application number: M017
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsExact identifier
application number: M017
KENS PAIN AND ARTHRITIS FORMULAMENTHOLEezaway Relief Inc35834473-3ad5-41ec-a110-e742aa7e2ee42026-07-28WarningsExact identifier
application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal CreamLIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.57935b64-6e2e-85d0-e063-6394a90a74282026-07-27WarningsExact identifier
application number: M017
1% Hydrocortisone Anti-itch1% HYDROCORTISONE ANTI-ITCHALAINA HEALTHCARE PRIVATE LIMITEDb8416467-55f7-4e5f-a5cb-3abd3e2bb5772026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC57984bc2-bf1d-c423-e063-6394a90a06ae2026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
723562benzocaine 20 % Topical CreamPSN605fc242-ad31-4aa9-bd86-fba4ddf0d30511
723562benzocaine 200 MG/ML Topical CreamSCD605fc242-ad31-4aa9-bd86-fba4ddf0d30511
723562benzocaine 20 % Topical CreamSY605fc242-ad31-4aa9-bd86-fba4ddf0d30511
723562benzocaine 20 % Topical CreamPSN97345ed4-51c3-4221-852c-2cd563f333178
723562benzocaine 200 MG/ML Topical CreamSCD97345ed4-51c3-4221-852c-2cd563f333178
723562benzocaine 20 % Topical CreamSY97345ed4-51c3-4221-852c-2cd563f333178

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54723-722-03547230722033000 mg in 1 PACKET (54723-722-03) 3000 mg2016-02-010000-00-00NoNoCurrent