Pain Release

Product NDC
70983-007
11-digit product format
709830007
Labeler code
70983
Product ID
70983-007_485126fc-a5e0-d844-e063-6394a90a2ada
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
OIL
Route
TOPICAL
Labeler
Saje Natural Business Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-16
Substance
MENTHOL
Active strength
12.18 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
MENTHOL12.18 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
92eec6e7-0367-43c6-bd28-1762390a7114Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-007-09Pain Release100 mL in 1 BOTTLE, PLASTICOIL1006
70983-007-09Pain Release1 in 1 BOXOIL16
70983-007-10Pain Release1 in 1 BOXOIL16
70983-007-10Pain Release200 mL in 1 BOTTLE, DROPPEROIL2006
70983-007-11Pain Release40 mL in 1 BOTTLE, PLASTICOIL406

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-007PAIN RELEASE (MENTHOL) OIL [SAJE NATURAL BUSINESS INC.]5Current NDC, Legacy NDC, 5 package rows20231006_92eec6e7-0367-43c6-bd28-1762390a7114.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 122 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sanar Naturals Arnica ReforzadaCAMPHORSanvall Enterprises, Inc1921a4b1-cd36-195e-e063-6294a90a87932024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica Pain Releiving Roll On with CamphorCAMPHORSanvall Enterprises, Inc173db0e2-611f-55b9-e063-6394a90ac9872024-10-31WarningsExact identifier
application number: M017
Sanar Naturals CamphorCAMPHORSanvall Enterprises, Inc1921e851-cf83-0bdb-e063-6294a90a357f2024-10-31WarningsExact identifier
application number: M017
cortisoneHYDROCORTISONECVS Pharmacyc766deac-d993-4e48-a5c3-4cfde7338dff2024-10-31WarningsExact identifier
application number: M017
Walgreens Pain Relieving with Lavender AnalgesicLIDOCAINE HYDROCHLORIDEWalgreen Company6c7b39c8-5b65-430a-a529-5b6b14adce182024-10-31WarningsExact identifier
application number: M017
Walgreens Pain Relieving Plus Turmeric AnalgesicTROLAMINE SALICYLATEWalgreen Companyf3a121bc-7572-49a4-9822-2b6d858c19d22024-10-31WarningsExact identifier
application number: M017
dg health hydrocortisoneHYDROCORTISONEDolgencorp, LLC27dc9e09-fc4f-4b66-a303-177725f3a5132024-10-31WarningsExact identifier
application number: M017
basic care hydrocortisoneHYDROCORTISONEAmazon.com Services LLCf5419859-3f9f-43ff-9a3f-6aa81af044f02024-10-31WarningsExact identifier
application number: M017
ARCTIC RELIEFMENTHOL, UNSPECIFIED FORMSTRATUS PHARMACEUTICALS INCd27fbc17-46b7-4d52-ba29-c99b6c63144a2024-10-31WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINE, MENTHOLR & Y Group, LLCfe0478d8-2f06-cd56-e053-6294a90a58e52024-10-30WarningsExact identifier
application number: M017
JOINT-RITIS PAIN RELIEVING ROLL-ONMENTHOLLifeline Naturals of America, Inc.ec5d99c4-6bba-45d1-84e0-12fb7cb314952024-10-30WarningsExact identifier
application number: M017
Walgreens Pain Relieving with Turmeric AnalgesicLIDOCAINE HYDROCHLORIDEWalgreen Company317ec4fb-cff0-461d-9ca0-299527a3686d2024-10-30WarningsExact identifier
application number: M017
Walgreens Pain Relieving AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEWalgreen Company3215a676-104c-43c3-aa36-b30d5b67799a2024-10-30WarningsExact identifier
application number: M017
Ultra-Strength Pain Relief AnalgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMTARGET CORPORATION159c5a84-bf68-41dd-a2d3-bc24020372442024-10-30WarningsExact identifier
application number: M017
DG Health Cold n Hot Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMDolgencorp Inc8fe13b85-ab74-42f8-a664-d3d2959921ac2024-10-30WarningsExact identifier
application number: M017
DEBACHERE Butt Balm After Care Antiseptic Pain ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLC8ba42864-69bf-455c-98d4-7f4ff94edceb2024-10-29WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafewaybeefab66-b056-4bf1-b047-0780704ab87e2024-10-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEH E B15eb4676-5f6e-4c28-b5b9-4e45412dc37a2024-10-29WarningsExact identifier
application number: M017
Rael PAIN RELIEF ROLL-ON AnalgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMRael, Inc.e6c49606-7c13-4dc6-a22d-ba54173ba7882024-10-28WarningsExact identifier
application number: M017
Monistat Care Instant Itch ReliefBENZOCAINEInsight Pharmaceuticals LLC4e9dc791-419f-4c79-aed4-760f8c17a5dd2024-10-25WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70983-007-09709830007091 BOTTLE, PLASTIC in 1 BOX (70983-007-09) / 100 mL in 1 BOTTLE, PLASTIC2020-06-290000-00-00NoNoCurrent
70983-007-10709830007101 BOTTLE, DROPPER in 1 BOX (70983-007-10) / 200 mL in 1 BOTTLE, DROPPER2016-10-160000-00-00NoNoCurrent
70983-007-117098300071140 mL in 1 BOTTLE, PLASTIC (70983-007-11) 40 ml2016-10-160000-00-00NoNoCurrent