Home NDC 54723-722 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 62 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Itch Eraser Gel DIPHENHYDRAMINE HCL Tender Corporation d/b/a Adventure Ready Brands 223c7cfd-6dc5-140a-e063-6394a90a8332 2025-11-17 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY Kroger Co. 6b3e7aac-395f-48cf-9c5e-f7e163724aef 2025-11-17 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY HY-VEE, INC 415ecfe9-3145-f23e-e063-6394a90adfd8 2025-11-17 Warnings Exact identifier application number: M017 AY BENDITO - CBD CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC 04b1d605-60aa-56f4-e063-6294a90ae760 2025-11-17 Warnings Exact identifier application number: M017 AY BENDITO - CBD CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC 0f1406fe-3a2f-bf36-e063-6294a90a7e5e 2025-11-17 Warnings Exact identifier application number: M017 AY BENDITO CBD MENTHOL, CAMPHOR AY BENDITO INTERNATIONAL, INC 30a1c6b7-e37e-32c2-e063-6394a90aa354 2025-11-17 Warnings Exact identifier application number: M017 ETERNAL SPIRIT BEAUTY PAINLESS WITH CBD 3000 MENTHOL, CAMPHOR Worldwide Cosmetics, Inc 0816cc8f-8d0b-de27-e063-6294a90a8a9d 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON COOLING MENTHOL Just Brands LLC f6538e3e-4663-679c-e053-2995a90a87b5 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON WARMING CAMPHOR Just Brands LLC f65455d7-04a9-6217-e053-2995a90a7c90 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD - CBD AND THC ULTRA RELIEF MENTHOL, CAMPHOR Just Brands LLC f664eb79-8897-3a49-e053-2995a90a37b4 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD RELIEF SOOTHING LIDOCAINE HCL Just Brands LLC f9aff6e7-5702-f61c-e053-6294a90aa66f 2025-11-17 Warnings Exact identifier application number: M017 JUST CBD SOOTHING MENTHOL, CAMPHOR Just Brands LLC 0abece07-976c-4881-e063-6294a90a5c1b 2025-11-17 Warnings Exact identifier application number: M017 Blue-Emu Thrive Pain Relief Cream TRIPELENNAMINE 0.5% Kingsway Pharmaceuticals dba NFI, LLC a4ba6787-c99b-4bf2-9f8f-e923ef976212 2025-11-14 Warnings Exact identifier application number: M017 CVS Cooling Patch MENTHOL CVS Pharmacy 42d97e29-f32d-a31b-e063-6394a90a88d8 2025-11-14 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Marlex Pharmaceuticals Inc 4de2bc60-dc4a-4417-984f-eabab0e926a6 2025-11-14 Warnings Exact identifier application number: M017 EXTREME EMU MENTHOL, METHYL SALICYLATE Renu Laboratories, LLC 4393b57b-1e70-b8dd-e063-6294a90ae748 2025-11-14 Warnings Exact identifier application number: M017 4x Medicated Toothache and Gum Cream BENZOCAINE Kroger a8c5090a-24f9-4e73-e053-2a95a90acca0 2025-11-14 Warnings Exact identifier application number: M017 PM Toothache Relief BENZOCAINE CVS 0a5a8cd0-d680-8a0f-e063-6294a90aa65c 2025-11-14 Warnings Exact identifier application number: M017 PM Toothache Relief BENZOCAINE Walgreens e816f742-fba9-3c12-e053-2a95a90a192f 2025-11-14 Warnings Exact identifier application number: M017 4x Medicated Toothache and Gum Cream BENZOCAINE Walgreens a71c2092-4ece-b82e-e053-2995a90ac933 2025-11-14 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# 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