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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54723-722-05IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54723-722-05IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54723-722-05IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54723-722-05IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54723-722-05IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54723-722-05UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54723-722-05UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54723-722-05UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54723-722-03EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54723-722-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
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 110 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dollar General Cold-Hot Medicated PatchesMENTHOLDOLGENCORP, LLCc6e0388b-af9e-4e51-8f94-6788185c31a02024-12-18WarningsExact identifier
application number: M017
THERA CARE PAIN THERAPYLIDOCAINEVeridian Healthcaree023bb5a-a4bc-4681-a1f4-48ca0d2cb1022024-12-18WarningsExact identifier
application number: M017
TheraCare Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEVeridian Healthcaref6f3c9c0-d6e3-75a3-e053-6294a90a19652024-12-18WarningsExact identifier
application number: M017
Good Sense Hot and Cold Medicated PatchMENTHOLGOOD SENSE1b16c3e5-a29f-4043-94e6-0a0e0ea3d93e2024-12-18WarningsExact identifier
application number: M017
Hunter Beach 4%LIDOCAINEHUNTERS BEACH LIFEf2ef9c12-6e42-486b-b6f2-0ad534e942942024-12-18WarningsExact identifier
application number: M017
Hunter Beach 4%LIDOCAINEHUNTERS BEACH LIFE05a9605b-0d01-4333-8e54-7202e7c31c492024-12-18WarningsExact identifier
application number: M017
Ultra Strength Muscle RubCAMPHOR, MENTHOL, METHYL SALICYLATEThe Mentholatum Company32b64985-0e2f-49ee-9840-946d7279fee72024-12-17WarningsExact identifier
application number: M017
CVS Health Cold and Hot Pain Relieving Extra StrengthMENTHOL, METHYL SALICYLATECVS Pharmacy1ca1a631-cb2c-46cd-bd41-05469b08d2082024-12-17WarningsExact identifier
application number: M017
Mentholatum Pain RelievingMENTHOL, METHYL SALICYLATEThe Mentholatum Company0056b952-9870-485a-9f35-f985472875a92024-12-17WarningsExact identifier
application number: M017
Mentholatum Lidocaine HeatLIDOCAINE HCLThe Mentholatum Companycc2ef25a-b569-4d48-a666-899f710b4b342024-12-17WarningsExact identifier
application number: M017
Rite Aid Muscle Rub Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATERite Aid Corporation039fff40-b5ba-42cb-932c-8a70ca92759d2024-12-17WarningsExact identifier
application number: M017
Signature Care Cold and Hot MedicatedMENTHOLSafeway88f59f95-0a7c-458c-949c-0dff16ad94e42024-12-17WarningsExact identifier
application number: M017
Equate Cool and HeatMENTHOL, METHYL SALICYLATEWal-Mart Stores Incc5ab2426-eeca-4ba4-9f00-7790d21764712024-12-17WarningsExact identifier
application number: M017
CVS Health Muscle Rub Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a2024-12-17WarningsExact identifier
application number: M017
DG Health Maximum Strength Pain Relieving CleansingBENZALKONIUM CL, LIDOCAINE HCLDollar General Corporation64f69315-77a3-49dc-940d-efd7a29c66452024-12-17WarningsExact identifier
application number: M017
ChiggerexBENZOCAINERANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH5e5d84ab-f57f-448d-a4c1-ced38890eec22024-12-17WarningsExact identifier
application number: M017
DerMend Moisturizing Anti-ItchPRAMOXINE HYDROCHLORIDEFerndale Laboratories, Inc.14c7fb1c-a310-4b12-ab2e-7f1c0801995c2024-12-17WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEGeri-Care Pharmaceuticals, Corpfd67566a-1076-019d-e053-6394a90a415c2024-12-17WarningsExact identifier
application number: M017
Extra StrengthMENTHOL AND METHYL SALICYLATENATURES FORMULAE HEALTH PRODUCTS LTD.d919b50a-5de2-1830-e053-2a95a90ab88d2024-12-17WarningsExact identifier
application number: M017
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLWalgreen Company1f262473-3f3c-4f3f-b507-590d06ff69a92024-12-17WarningsExact 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
54723-722-04547230722041500 mg in 1 PACKET (54723-722-04) 1500 mg2024-07-29NoNoCurrent
54723-722-05547230722055000 mg in 1 PACKET (54723-722-05) 5000 mg2017-08-210000-00-00NoNoCurrent