FDA.reportPublic FDA data

Pain Relief Gel-Patch

Product NDC
83016-171
11-digit product format
830160171
Labeler code
83016
Product ID
83016-171_25ac4fb1-be51-69e9-e063-6394a90a7a64
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
R & Y Group, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-15
Substance
MENTHOL; LIDOCAINE
Active strength
.12; .48 g/12g; g/12g
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
Pain Relief Gel-Patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.12 g/12g
LIDOCAINE.48 g/12g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1249758Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe0478d8-2f06-cd56-e053-6294a90a58e5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83016-171-01Pain Relief Gel-Patch12 g in 1 PACKETPATCH122
83016-171-07Pain Relief Gel-Patch7 in 1 POUCHPATCH72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83016-171PAIN RELIEF GEL-PATCH (LIDOCAINE, MENTHOL) PATCH [R & Y GROUP, LLC]2Current NDC, 2 package rows20241031_fe0478d8-2f06-cd56-e053-6294a90a58e5.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 104 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact identifier
application number: M017
Lidocare Arm, Neck, Leg4% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC59a104ee-7034-99c3-e053-2991aa0a164c2025-01-06WarningsExact identifier
application number: M017
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu Pharmaceutical Co., Inc.4f3a438c-f378-4d2a-a95c-58e56cf1e7972025-01-06WarningsExact identifier
application number: M017
Lidocare 034% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC416ebf5a-2efb-6d0b-e054-00144ff88e882025-01-06WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll-onMENTHOLADP Health Limitede0bb77b2-45ee-45fa-9659-9c7d99bb20dc2025-01-05WarningsExact identifier
application number: M017
health and beyond BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b6bb3ed-50fb-40c4-acb6-ae3f160315312025-01-05WarningsExact identifier
application number: M017
glo SKIN BEAUTY Remedy GelGLO SKIN BEAUTY REMEDY GELHayden Caleel LLCaa47ff08-07b3-4fd1-bae5-420e4b928f062025-01-05WarningsExact identifier
application number: M017
Capsaicin 0.025% CreamCAPSAICIN 0.025%Puretek Corporation28f00df0-c416-f17b-e063-6294a90a55702025-01-02WarningsExact identifier
application number: M017
AVON HeXashield Pain Relief for Muscle, Back and Joint CreamCAMPHOR, MENTHOL, METHYL SALICYLATETai Guk Pharm. Co., Ltd.8f29ffd7-48b9-109f-e053-2995a90ab2152025-01-01WarningsExact identifier
application number: M017
AVON HeXashield Arthritis Pain Relief Cream CapsaisinCAPSAISINTai Guk Pharm. Co., Ltd.8f286a9d-8765-21b3-e053-2a95a90ae43a2025-01-01WarningsExact identifier
application number: M017
AVON HeXashield Anti Itch Cream with Healing AloeHYDROCORTISONETai Guk Pharm. Co., Ltd.8f2aa11d-d794-6f3e-e053-2995a90a1d9d2025-01-01WarningsExact identifier
application number: M017
HeXashield Anti Itch Cream with Healing AloeHYDROCORTISONETai Guk Pharm. Co., Ltd.b9d033f3-4d12-a2c8-e053-2995a90ac7f12025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Pain Relief with MentholMENTHOLGreen Compass, Inc.0a0c212e-ae5d-8505-e063-6394a90af6222025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEGreen Compass, Inc.0a0b688e-50f1-3eb1-e063-6394a90a7efa2025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Topical PainCAMPHOR, MENTHOL, METHYL SALICYLATEGreen Compass, Inc.8cb80362-5d24-1ee3-e053-2a95a90afcdf2025-01-01WarningsExact identifier
application number: M017
Green Compass Reduce Roll-On Pain ReliefMENTHOLGreen Compass, Inc.b5916aa2-428c-5637-e053-2995a90a08b02025-01-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSNfe0478d8-2f06-cd56-e053-6294a90a58e52
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCDfe0478d8-2f06-cd56-e053-6294a90a58e52
1249758lidocaine 4 % / menthol 1 % Medicated PatchSYfe0478d8-2f06-cd56-e053-6294a90a58e52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83016-171-018301601710112 g in 1 PACKET12 gHistorical
83016-171-07830160171077 PACKET in 1 POUCH (83016-171-07) / 12 g in 1 PACKET (83016-171-01) 7 packet2023-06-15NoNoCurrent