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 91 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Everlight Survival Sting Relief PadBENZOCAINEYiwu Ori-Power Medtech Co.,Ltd.364c9882-339e-fe22-e063-6294a90a37f42025-06-04WarningsExact identifier
application number: M017
LIGHTS Sting Relief Prep PadBENZOCAINELights Medical Manufacture Co., Ltd.4f4d7758-be62-4304-8871-087a90497fa52025-06-04WarningsExact identifier
application number: M017
Elsophie Nicotine Patches QuitNICOTINE PATCHES QUIT SMOKINGShenzhen Xinxin Yunhai Technology Co., Ltd.36b63da9-94cc-b52a-e063-6394a90a50292025-06-03WarningsExact identifier
application number: M017
BurnLIDOCAINE HYDROCHLORIDEJ&A Digital Inc.d4b09055-b93e-466f-9e24-cae098af6e242025-06-02WarningsExact identifier
application number: M017
RE-LEVEMENTHOLSOMBRA COSMETICS INC.b4b39d79-0439-41e7-adca-e5ccb8f44e402025-05-29WarningsExact identifier
application number: M017
PAIN NO MORE THERAPYMENTHOL CAMPHORSOMBRA COSMETICS INC.f7bacc8e-6a8b-4cd8-bd0e-68890bee58182025-05-29WarningsExact identifier
application number: M017
DermaD ANTI-ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.8f4a57cb-0a5b-42b0-a325-1f92f3942ad92025-05-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESun Pharmaceutical Industries, Inc.f7aecfb4-c194-4554-8d05-4e46005e654b2025-05-27WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATENantong Health & Beyond Hygienic Products Inc.b679ed7b-9d88-4eff-9743-567affe0fe2b2025-05-27WarningsExact identifier
application number: M017
RockSauce Warming Massage Roll OnMENTHOL, METHYL SALICYLATENantong Health & Beyond Hygienic Products Inc.28eb8273-5789-4f33-bbbe-3a5ec7bc79292025-05-27WarningsExact identifier
application number: M017
AUVON Pain Relief CreamLIDOCAINESHENZHEN YUWEN E-COMMERCE CO., LTD.358c2632-3b90-1c54-e063-6294a90ad4612025-05-22WarningsExact identifier
application number: M017
WelAhead by Welmate Lidocaine 5% Roll-onLIDOCAINE 5%OTC PHARM LLC0b75e83e-8c7b-6247-e063-6294a90ac4132025-05-21WarningsExact identifier
application number: M017
Bliss RepublicLIDOCAINE NUMBING EXTRA STRENGTH CREAMSargass Group Limited Liability Company35aba13a-95e6-a395-e063-6294a90a5bdc2025-05-21WarningsExact identifier
application number: M017
Xpect Stopain ClinicalMENTHOLCintas Corporatione911478f-7153-4700-b945-92ec54972f452025-05-21WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHPreferred Pharmaceuticals Inc.0976a898-8d79-4b85-b473-c8ad32b4fd002025-05-20WarningsExact identifier
application number: M017
Numbing CreamLIDOCAINE100 KARMA INC359884d6-188a-e503-e063-6294a90acab42025-05-20WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO - THERMOACTIVE LOTION835abc66-680f-be06-e053-2a91aa0a309e2025-05-19WarningsExact identifier
application number: M017
Numbing CreamLIDOCAINE100 KARMA INC35884644-d017-eda3-e063-6394a90a1f6c2025-05-19WarningsExact identifier
application number: M017
QUIT SMOKING Proven PatchesNICOTINEJiashen International Trade Limited35570155-c769-dc4c-e063-6394a90a019d2025-05-17WarningsExact identifier
application number: M017
VBBV Tattoo NumbingLIDOCAINEJiashen International Trade Limited3557859e-f8b3-1049-e063-6394a90ad7372025-05-17WarningsExact 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