Pain Release

Product NDC
70983-005
11-digit product format
709830005
Labeler code
70983
Product ID
70983-005_48511a10-f9ec-bee8-e063-6394a90a913f
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Saje Natural Business Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-16
Substance
MENTHOL
Active strength
2.23 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2.23 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a32b0950-3467-4e37-988d-104836af5971Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-005-08Pain Release1 in 1 BOXLIQUID15
70983-005-08Pain Release100 mL in 1 BOTTLE, SPRAYLIQUID1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-005PAIN RELEASE (MENTHOL) LIQUID [SAJE NATURAL BUSINESS INC.]4Current NDC, Legacy NDC, 2 package rows20231006_a32b0950-3467-4e37-988d-104836af5971.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 110 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Cold and Hot Menthol PatchMENTHOLRite Aid Corporationbd46ac50-aaf8-b4e8-e053-2995a90aea612024-12-18WarningsExact identifier
application number: M017
Rite Aid Hot and Cold Back PatchMENTHOLRite Aid Corporationefa51d1f-ed09-680c-e053-2a95a90af1b22024-12-18WarningsExact identifier
application number: M017
Maximum Strenght Lidocaine plus Menthol Pain Relief PatchLIDOCAINE, MENTHOLRite Aid Corporationbd34a5bd-af5a-680f-e053-2995a90abc742024-12-18WarningsExact identifier
application number: M017
Rite Aid Lidocaine Patch XLargeLIDOCAINERite Aid Corporationefa531c2-4956-e93a-e053-2995a90ae0ea2024-12-18WarningsExact identifier
application number: M017
Maximum Strength Pain Relief Lidocaine PatchLIDOCAINERite Aid Corporationbd31105a-f73f-2f57-e053-2995a90a59c02024-12-18WarningsExact identifier
application number: M017
Meijer Lidocaine Pain Relief Patch Assortment MediumLIDOCAINEMeijer Distribution Incab83b445-0e11-b985-e053-2995a90a02782024-12-18WarningsExact identifier
application number: M017
Meijer Lidocaine Pain Relief Patch Assortment LargeLIDOCAINEMeijer Distribution Incaa7f9bc8-0d56-5dde-e053-2a95a90af0e72024-12-18WarningsExact identifier
application number: M017
Meijer Lidocaine Pain Relief Patch Assortment SmallLIDOCAINEMeijer Distribution Incab85ce5a-8787-4317-e053-2a95a90a62bc2024-12-18WarningsExact identifier
application number: M017
MEIJER LIDOCAINE PAIN RELIEF BACK AND LARGE AREASLIDOCAINEMeijer Distribution Incb9e512e3-8337-1f44-e053-2a95a90a7fcb2024-12-18WarningsExact identifier
application number: M017
Hot and Cold Medicated PatchMENTHOLVeridian Healthcare67446b19-3296-42f1-9e5f-2bb7938017c02024-12-18WarningsExact identifier
application number: M017
Thera Care Hot and Cold Medicated PatchMENTHOLVeridian Healthcarec9c6eb07-39ef-4c87-b463-d1960abdf2022024-12-18WarningsExact identifier
application number: M017
HealthWise Lidocaine Pain reliefLIDOCAINEVeridian Healthcarece28a1d0-49f1-ed6f-e053-2a95a90a50db2024-12-18WarningsExact identifier
application number: M017
HealthWise Menstrual Pain Relief PatchMENTHOLVeridian Healthcareee62e44e-a09f-2e58-e053-2a95a90abe042024-12-18WarningsExact identifier
application number: M017
THERA CARE 24hrs Lidocaine PatchLIDOCAINE 4%Veridian Healthcareaa93e05e-46ce-3bc4-e053-2a95a90aa46c2024-12-18WarningsExact identifier
application number: M017
Caring Mills Relief Patch with LidocaineLIDOCAINE 4%Veridian Healthcaref161a8e2-b6df-27d7-e053-2995a90aa01c2024-12-18WarningsExact identifier
application number: M017
HealthWise Lidocaine and Menthol Pain ReliefLIDOCAINE AND MENTHOLVeridian Healthcarece2e9d9b-b4a4-ab61-e053-2a95a90a06422024-12-18WarningsExact identifier
application number: M017
MEIJER PAIN RELIEF PATCHESLIDOCAINEMeijer Distribution Incf591588e-467b-4c37-b0e1-c0be844220412024-12-18WarningsExact identifier
application number: M017
TheraCare Pain Relieving Patch with LidocaineLIDOCAINEVeridian Healthcaref93b00e1-06d6-9066-e053-6294a90ae89a2024-12-18WarningsExact identifier
application number: M017
Large Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEMeijer Distribution Incf2928904-a202-414a-b262-287a0a7bda932024-12-18WarningsExact identifier
application number: M017
Meijer Large Cold-Hot Medicated PatchesMENTHOLMeijer Distribution Incaf0e7609-c320-414a-9df6-dfb3b08c8b822024-12-18WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70983-005-08709830005081 BOTTLE, SPRAY in 1 BOX (70983-005-08) / 100 mL in 1 BOTTLE, SPRAY2016-10-160000-00-00NoNoCurrent