FDA.reportPublic FDA data

NeuroMed 7 Topical Pain Relief

Product NDC
54723-175
11-digit product format
547230175
Labeler code
54723
Product ID
54723-175_436c8b3b-78e6-5906-e063-6394a90a9c3c
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Sambria Pharmaceuticals, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-15
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
4 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

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 · 2 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 productproduct54723-175EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54723-17554723-175-22EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…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 7 Topical Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010895Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f199f56b-d971-4cf8-834d-babb5c2ff81aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54723-175-22NeuroMed 7 Topical Pain Relief1 in 1 CARTONCREAM115
54723-175-22NeuroMed 7 Topical Pain Relief63 g in 1 TUBECREAM6315

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ANEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
LIDOCAINEACTIVE MOIETY98PI200987NEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZWNEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70NEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
CHONDROITIN SULFATE (BOVINE)INACTIVE INGREDIENT6IC1M3OG5ZNEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BNEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTNEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
EMU OILINACTIVE INGREDIENT344821WD61NEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PNEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
GLUCOSAMINE SULFATEINACTIVE INGREDIENT1FW7WLR731NEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MNEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201NEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TNEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKNEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RNEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54723-175NEUROMED 7 TOPICAL PAIN RELIEF (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]13Current NDC, Legacy NDC, 2 package rows20240727_f199f56b-d971-4cf8-834d-babb5c2ff81a.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 21 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLASCLEMED USA INC.68dc0231-3364-448b-bde9-f19fa122c7652026-05-05WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINE 4%SOLA Pharmaceuticalsc31957dd-edea-ce98-e053-2a95a90a9c2d2026-05-05WarningsExact identifier
application number: M017
Biofreeze Triple Target GelCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC511852c8-7428-3234-e063-6394a90a5bc22026-05-05WarningsExact identifier
application number: M017
5Kind DMSO Pain RelievingCAMPHOR (SYNTHETIC)5Kind Trading LTD62b55114-47f4-473a-8406-78238c3c1fa22026-05-04WarningsExact identifier
application number: M017
Zinc Oxide with Menthol and White PetrolatumMENTHOL, ZINC OXIDE, WHITE PETROLATUMAldermed Inc.f993fc0a-bd80-4345-a948-65ac03f910e22026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDEEVERLIT GLOBAL INC.d7ec5720-4d1f-4943-ae36-c7d6acbae7d72026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.5371dae4-ea63-46cc-ac26-5418f359c63e2026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a2cf1726-3dc9-4624-b898-ac91fb4cbdb22026-05-04WarningsExact identifier
application number: M017
FIRSTAR BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.186343c5-2e71-49c4-8d64-5fb3131239fa2026-05-04WarningsExact identifier
application number: M017
Feminine Anti Itch CreamBENZOCAINE,RESORCINOLTRIFECTA PHARMACEUTICALS USA LLC50c3acbf-b873-908a-e063-6294a90a66b72026-05-01WarningsExact identifier
application number: M017
24 7 Relief and Recovery Pain RelievingMENTHOL, UNSPECIFIED FORMTriplicare Inc53ca807b-3ec2-4b5e-aa5a-6dcb756bb4232026-04-30WarningsExact identifier
application number: M017
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE4 Visions LLC50b1351d-72dd-e0c9-e063-6294a90ac7432026-04-30WarningsExact identifier
application number: M017
TheraCare Flexible Pain RelievingLIDOCAINEVeridian Healthcare4f108002-2cae-0671-e063-6294a90ab6cf2026-04-30WarningsExact identifier
application number: M017
Pain Relief Gel Roll OnMENTHOLTrifecta Pharmaceuticals USA50b1a420-d5cd-6d61-e063-6294a90a04512026-04-30WarningsExact identifier
application number: M017
Dr. NumbLIDOCAINE AND BENZETHONIUM CHLORIDE CREAMShinpharma Incd8cdccdb-775b-4970-a6ea-50b62df221d62026-04-30WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd2dc7f76f-f9ad-46ba-8b41-952e1c15f0522026-04-29WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEHyVee Ince1db3641-2e83-4fec-8394-98d0d876ce0d2026-04-29WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA50805eee-33b3-86bd-e063-6294a90a77d82026-04-28WarningsExact identifier
application number: M017
FixMySkin Healing Balm Vanilla FlavorHYDROCORTISONELovely Skin, Inc.52f7a561-a0b5-4562-a588-d74fd874b83a2026-04-28WarningsExact identifier
application number: M017
Blue Star MedicatedCAMPHORFocus Consumer Healthcare, LLC56df008e-a23b-4870-e054-00144ff8d46c2026-04-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010895lidocaine HCl 4 % Topical CreamPSNf199f56b-d971-4cf8-834d-babb5c2ff81a15
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCDf199f56b-d971-4cf8-834d-babb5c2ff81a15
1010895lidocaine hydrochloride 4 % Topical CreamSYf199f56b-d971-4cf8-834d-babb5c2ff81a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54723-175-22547230175221 TUBE in 1 CARTON (54723-175-22) / 63 g in 1 TUBE1 tube2016-04-130000-00-00NoNoCurrent