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 45 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
application number: M017
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
application number: M017
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLUniversal Distribution Center LLC66892993-a755-4584-b2a8-2e8d7ac705932026-01-08WarningsExact identifier
application number: M017
Private Label Antifungal Barrier Cream2% MICONAZOLE NITRATE CREAMSwiss-American CDMO, LLCe74bddea-c1ac-4e4e-84bd-5a9defb85b2d2026-01-08WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLCe1911279-85f7-4053-b6da-8f4e991347a22026-01-08WarningsExact identifier
application number: M017
POMG PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDE, MENTHOLPOMG LLC1fa980fb-fc0e-fdd0-e063-6394a90adc132026-01-07WarningsExact identifier
application number: M017
Artridon GlucosamineMENTHOL, METHYL SALICYLATEPharmadel LLC73572156-4cce-0669-e053-2991aa0aaecc2026-01-07WarningsExact identifier
application number: M017
HealthWise Cooling Pain ReliefMENTHOLVeridian Healthcare6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd2026-01-07WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-Itch CreamHYDROCORTISONEDLC Laboratories, Inc.16eeec2c-065d-4da0-e063-6294a90a38732026-01-07WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONEDLC Laboratories, Inccaf50f12-f35c-4e9e-8ef7-3b0c84e225ee2026-01-07WarningsExact identifier
application number: M017
EARTHS CARE MUSCLE AND JOINT RUBCAMPHORDLC Laboratories, Inc.71e33e06-4dc3-4ead-a122-ff89d93a64de2026-01-07WarningsExact identifier
application number: M017
Amour CBDPAIN RELIEF CREAMSVD Premium Products95b45e79-b1e7-17b2-e053-2995a90a88362026-01-07WarningsExact identifier
application number: M017
Tiger Balm Active MuscleMETHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.845a4ead-f9c0-4009-bcae-b17cd388439b2026-01-07WarningsExact identifier
application number: M017
3X Medicated Toothache and Gum GelBENZOCAINERite Aid996f7989-17ce-5b28-e053-2995a90af8b82026-01-06WarningsExact identifier
application number: M017
QNTAMAX Muscle and Joint Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLQntamax LLC6622b94c-824e-4e84-a8d8-b60bb0b866e22026-01-06WarningsExact identifier
application number: M017
Winco Muscle and Joint Pain Relief Gel 2ozWINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEFWINCO FOODS, LLC47bedf4e-4036-cf43-e063-6394a90a91d62026-01-06WarningsExact identifier
application number: M017
Pain Relief Hot PatchMENTHOL AND CAPSAICINUniversal Distribution Center LLC110bcb16-ef0b-4bc8-8877-173a0494e1ad2026-01-06WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4582b4e9-0c24-069d-e063-6394a90a6f4b2026-01-05WarningsExact 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