FDA.reportPublic FDA data

Prolayed

Product NDC
79218-001
11-digit product format
792180001
Labeler code
79218
Product ID
79218-001_0b6e190a-d192-f957-e063-6294a90a8cfe
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
Dosage form
SPRAY
Route
TOPICAL
Labeler
MATRIX MIXOLOGY, INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-01
Substance
LIDOCAINE
Active strength
10 mg/mL
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

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
Prolayed
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae317876-adb1-6d13-e053-2995a90a74afAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79218-001-01Prolayed1 in 1 BOXSPRAY12
79218-001-01Prolayed15 mL in 1 BOTTLESPRAY152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79218-001PROLAYED (LIDOCAINE) SPRAY [MATRIX MIXOLOGY, INC]2Current NDC, Legacy NDC, 2 package rows20231202_ae317876-adb1-6d13-e053-2995a90a74af.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 57 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neuracin Topical GelNEURACIN TOPICAL ANALGESIC GELSOLA Pharmaceuticalsc3166926-30c2-2128-e053-2a95a90a0bf22025-12-08WarningsExact identifier
application number: M017
TriceptinLIDOCAINE / MENTHOL / METHYL SALICYLATESOLA Pharmaceuticalsef1b98ab-d2db-038c-e053-2995a90a94b42025-12-08WarningsExact identifier
application number: M017
SynoFlex PatchSYNOFLEX PATCHSola Pharmaceuticalsde2042c4-6c5e-7365-e053-2a95a90ada2a2025-12-08WarningsExact identifier
application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1NICOTINE TRANSDERMAL PATCHESPCHEERY LLC457c860b-091d-8350-e063-6294a90a2f982025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMPMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC457c9bd6-2e72-03e5-e063-6394a90a558c2025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMP ROLL-ONCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC3e552afc-9305-8825-e063-6294a90a1afe2025-12-08WarningsExact identifier
application number: M017
AY BENDITO HEMPCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC457d89aa-4a84-94a6-e063-6294a90a20c02025-12-08WarningsExact identifier
application number: M017
Gold Bond Medicated Anti-ItchPRAMOXINE HYDROCHLORIDE, MENTHOLGold Bond Co LLC4a2bd277-47dd-4ae6-9b4b-e0ae9aad226b2025-12-05WarningsExact identifier
application number: M017
Orajel for Cold Sores Double Medicated, CreamBENZOCAINE AND WHITE PETROLATUMChurch & Dwight Co., Inc.b8699a40-8464-ca02-e053-2995a90a42602025-12-05WarningsExact identifier
application number: M017
Thompson Hydrocortisone 1%HYDROCORTISONEThompsonf8740314-7e1f-815e-e053-6294a90a6eae2025-12-05WarningsExact identifier
application number: M017
JUST CBD SOOTHING UNSCENTEDLIDOCAINE HCLJust Brands LLC453f44e2-9e5b-8695-e063-6394a90a43892025-12-05WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC453fa1a7-368c-ae50-e063-6294a90a55072025-12-05WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC4540221f-cf9f-9b6a-e063-6294a90adec32025-12-05WarningsExact identifier
application number: M017
Gold Bond Extra StrengthMENTHOLGold Bond Co LLC3e84375f-95d3-420c-b222-02a7574125922025-12-04WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLCb3ec09b9-7511-0895-e053-2a95a90a78402025-12-04WarningsExact identifier
application number: M017
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLCd240e9b8-3506-42ab-8a50-05e8d3fac4ff2025-12-04WarningsExact identifier
application number: M017
BLT Skin CreamBENZOCAINE, LIDOCAINE, TETRACAINEM2B Pharma LLC9dc5db9d-9e0a-cd28-e053-2995a90a6bf72025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbc66bc1b-c0d5-2481-e053-2a95a90a75de2025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafd199a-e198-d5d1-e053-2995a90ad1cb2025-12-04WarningsExact identifier
application number: M017
AleveXCAMPHOR AND MENTHOLBayer HealthCare LLCbafdf06b-25f5-e29e-e053-2a95a90a5e1b2025-12-04WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79218-001-01792180001011 BOTTLE in 1 BOX (79218-001-01) / 15 mL in 1 BOTTLE1 bottle2020-07-010000-00-00NoNoCurrent