FDA.reportPublic FDA data

Pain Release

Product NDC
70983-004
11-digit product format
709830004
Labeler code
70983
Product ID
70983-004_484f674c-ba73-e18f-e063-6394a90a896b
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GRANULE
Route
TOPICAL
Labeler
Saje Natural Business Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-16
Substance
MENTHOL
Active strength
1.6 mg/g
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
MENTHOL1.6 mg/g

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
1ac2ed54-194c-4de2-8e7f-6e74ca32aa40Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-004-05Pain Release300 g in 1 BOTTLE, PLASTICGRANULE3005
70983-004-06Pain Release620 g in 1 BOTTLE, PLASTICGRANULE6205
70983-004-07Pain Release1 in 1 PACKETGRANULE15
70983-004-07Pain Release120 g in 1 POUCHGRANULE1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-004PAIN RELEASE (MENTHOL) GRANULE [SAJE NATURAL BUSINESS INC.]4Current NDC, Legacy NDC, 4 package rows20231006_1ac2ed54-194c-4de2-8e7f-6e74ca32aa40.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 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
anti itchHYDROCORTISONEMeijer, Inc.2db7bcab-acb8-48ad-8cd1-842ff7765ed92024-10-23WarningsExact identifier
application number: M017
NATUREANCE MIRACLEMENTHOLEROS GLOBAL CORPec1a2a1f-a38d-9c59-e053-2a95a90ad2682024-10-23WarningsExact identifier
application number: M017
Profoot Plantar Relief StripsCAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.65e142d8-da21-4c55-9faf-b387cb6c2c0e2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.cc011b79-2761-40f7-8142-88f8e30a179a2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEProfoot, Inc.06f82bde-41a1-35f6-e063-6394a90a64372024-10-23WarningsExact identifier
application number: M017
Deep Cover Bug Bite ReliefBENZOCAINEMorrisons Outdoors, LLC25010dd6-fb48-8ee7-e063-6394a90aee6c2024-10-21WarningsExact identifier
application number: M017
Evel Knievels Natural Choice Pain ReliefMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.4576656c-4b6e-6965-7665-6c52756c65732024-10-21WarningsExact identifier
application number: M017
berkley and jensen anti itchHYDROCORTISONEBJWC5cc6e4f6-c62d-4923-9726-9dbc569a3f492024-10-19WarningsExact identifier
application number: M017
DG Health Hydrocortisone Maximum StrengthHYDROCORTISONEDolgencorp Inc2cc792b8-dce6-4178-bd6d-63ba268b77472024-10-19WarningsExact identifier
application number: M017
Careland Hydrogel Pain Relief PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.e970070c-1c3b-49f0-8298-e6c5ebbf50a02024-10-18WarningsExact identifier
application number: M017
Fruit of the Earth Cool Blue Aloe Mist ContinuousLIDOCAINE HYDROCHLORIDEFruit Of The Earth, Inc.d4caae4c-efba-2453-e053-2995a90a5e5f2024-10-18WarningsExact identifier
application number: M017
CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-RelievingLIDOCAINE HCLCVS Pharmacyf0f1969d-10e0-76ee-e053-2995a90a73362024-10-17WarningsExact identifier
application number: M017
Wong To Yick External AnalgesicCAMPHOR MENTHOL METHYL SALICYLATEWong To Yick Wood Lock Ointment Ltd16a21af4-6bc0-4ae1-aa3b-1da84c8286e22024-10-17WarningsExact identifier
application number: M017
Wong To Yick External AnalgesicCAMPHOR MENTHOL METHYL SALICYLATEWicsun Trading Inc0b4bd444-b3c1-47aa-a7e3-f16c923261242024-10-17WarningsExact identifier
application number: M017
Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCLLIDOCAINEFruit of the Earth, Inc.c7a833bd-7457-73a3-e053-2a95a90ac53f2024-10-17WarningsExact identifier
application number: M017
Wegmans Aloe After Sun Gel with Lidocaine HCl External AnalgesicLIDOCAINE HYDROCHLORIDEWEGMANS FOOD MARKETS INCf70bc438-7ed8-f74d-e053-6394a90a2b3f2024-10-16WarningsExact identifier
application number: M017
EQUATE Sunburn relief with Aloe After SunLIDOCAINEWal-Mart Stores Incc25e1288-7ac6-41fc-ab65-26c379f288a72024-10-16WarningsExact identifier
application number: M017
Genuine First Aid Insect Sting Relief Pad 1 ctBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.b119ba37-0ee1-851a-e053-2995a90a85b12024-10-15WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEWalgreen Company1a587e6e-88d1-4b01-abad-9a365dc64a4d2024-10-15WarningsExact identifier
application number: M017
TopCare Everyday After Sun CoolingLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATES LLCbaff7293-e1a3-d1f2-e053-2995a90a93ca2024-10-15WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70983-004-0570983000405300 g in 1 BOTTLE, PLASTIC (70983-004-05) 300 g2020-06-290000-00-00NoNoCurrent
70983-004-0670983000406620 g in 1 BOTTLE, PLASTIC (70983-004-06) 620 g2016-10-160000-00-00NoNoCurrent
70983-004-07709830004071 POUCH in 1 PACKET (70983-004-07) / 120 g in 1 POUCH1 pouch2016-10-160000-00-00NoNoCurrent