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 99 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone with aloeHYDROCORTISONEEncube Ethicals, Inc.12a1774d-a97e-4787-b6b1-8e8cd40b7b702025-02-26WarningsExact identifier
application number: M017
Thera Plus Maximum Strength Feminine Anti-ItchBENZOCAINE, RESORCINOLFOURSTAR GROUP USA, INC.0007e3ea-882b-4000-8e70-2bcec2c086132025-02-26WarningsExact identifier
application number: M017
Tattoo numbing creamLIDOCAINEBLOOMWELL GARDENS LLC2ea9d34e-408d-f8d6-e063-6394a90a72a42025-02-26WarningsExact identifier
application number: M017
Icy Hot Pro No-MessCAMPHOR, MENTHOLChattem, Inc.9e8fedf5-fb59-4531-b288-715f851ee05b2025-02-26WarningsExact identifier
application number: M017
Family Wellness Max Strength 1 Hydrocortisone CreamHYDROCORTISONEFamily Dollar Stores, Incbca5ac2c-45cd-44e3-98f1-317a04e44d7d2025-02-25WarningsExact identifier
application number: M017
Tylenol Precise Nighttime Pain RelievingCAMPHOR, MENTHOLKenvue Brands LLC2ef4fe16-0820-6aad-e063-6294a90a84492025-02-25WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEPreferred Pharmaceuticals Inc.c259ef92-5d07-4590-adf1-3a106333eee02025-02-21WarningsExact identifier
application number: M017
Cortizone 10 Ultra Soothing Itch ReliefHYDROCORTISONEChattem, Inc.8a9e2d32-a65f-4253-8041-4146f4e3b7382025-02-21WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll OnMENTHOLADP Health Limited420d8cdc-f47f-4d33-bf25-9033ff266c492025-02-19WarningsExact identifier
application number: M017
AVCOO Pain ReliefMENTHOLADP Health Limited700ce2cf-749e-40be-91c3-850d9b2168ca2025-02-19WarningsExact identifier
application number: M017
Sunburn Relief GelLIDOCAINE HCLJell Pharmaceuticals Pvt. Ltd2e7c49de-5438-4858-e063-6294a90ad98c2025-02-19WarningsExact identifier
application number: M017
VTROUY Tattoo Numbing CreamTATTOO NUMBING CREAMGuangzhou Zanming Trading Co., Ltd.2e899851-b3cd-0758-e063-6294a90afea82025-02-19WarningsExact identifier
application number: M017
Pomada Dragon Pain ReliefMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATEGenomma Lab USA9d98f48b-6d88-4df9-9459-7cf7ba5de0442025-02-19WarningsExact identifier
application number: M017
Pain Relieving CreamHISTAMINE DIHYDROCHLORIDEMediapower, Inc. DBA Dr Newton's And Naturals9eeea033-ae87-4d83-85d0-b8fa653a08062025-02-19WarningsExact identifier
application number: M017
Sure Complete Confidence Antiperspirant Deodorant Aerosol, RegularALUMINUM CHLOROHYDRATESodalis USA, LLC7839cf53-dbd2-4dbb-a309-1581d51f8adc2025-02-18WarningsExact identifier
application number: M017
CANNA NUMB Roll OnLIDOCAINE HYDROCHLORIDE, MENTHOLCannanumb LLCc1eb0348-3b0e-4f1c-a46b-1ff4aa165fb42025-02-17WarningsExact identifier
application number: M017
Vaporizing Chest Rub 4 oz.CAMPHOR, EUCALYPTUS OIL, MENTHOLRejoice International Inc.7173b141-123e-6cd4-e053-2a95a90a86002025-02-12WarningsExact identifier
application number: M017
Vaporizing Chest Rub 4 oz. 3 pkCAMPHOR, EUCALYPTUS OIL, MENTHOLRejoice International Inc.71c186a1-8283-2482-e053-2995a90acc1f2025-02-12WarningsExact identifier
application number: M017
Roman SwipesBENZOCAINERoman Health Ventures Inc.7f0eac8c-7235-99d8-e053-2a91aa0a634e2025-02-12WarningsExact identifier
application number: M017
SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOREVI LABSEVI LABS2df7658d-83d3-41ac-e063-6294a90ab1dd2025-02-12WarningsExact 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