Cool Azul Pain Relief Cream

Product NDC
70631-957
11-digit product format
706310957
Labeler code
70631
Product ID
70631-957_5155b47b-423e-3c41-e063-6294a90aef10
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl salicylate, Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Young Living Essential Oils, LC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-16
Substance
METHYL SALICYLATE; MENTHOL
Active strength
125; 20 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct70631-957IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70631-95770631-957-02IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70631-95770631-957-34IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
Cool Azul Pain Relief Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE125 mg/g
MENTHOL20 mg/g

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 34 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF4a7f92d3-dd35-44a3-e063-6294a90ae0042026-02-10WarningsExact identifier
application number: M017
NICOVITO HEMORRHOID MASTERLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTERJiangxi Yudexi Pharmaceutical Co., LTD4a5e24fa-959e-79b4-e063-6294a90a8f682026-02-09WarningsExact identifier
application number: M017
Tiger Balm Active Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.2e7638c6-e1ce-4e2f-bd50-52fbce5a138e2026-02-09WarningsExact identifier
application number: M017
Tiger Balm Neck and Shoulder RubCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.2f272d12-7b34-430e-817e-1005f57ed9e92026-02-09WarningsExact identifier
application number: M017
Welmate Lidocaine Pain Relieving PatchLIDOCAINEYYBA CORP4303fd30-0d35-3671-e063-6394a90a2aee2026-02-09WarningsExact identifier
application number: M017
Pain Relief LidocaineLIDOCAINEKroger Company4098756e-3d9f-317a-e063-6394a90af04c2026-02-09WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey4a698246-05a6-d01f-e063-6294a90a34012026-02-09WarningsExact identifier
application number: M017
Hemorrhoid MasterLIDOCAINE, PHENYLEPHRINEEbanel Laboratories, Inc41292d65-dabe-4bc3-872f-34a3912aa3422026-02-09WarningsExact identifier
application number: M017
DERMFREE NEUROPATHYARNICA MONTANA 1X HPUS 7% NEUROPATHYJiangxi Yudexi Pharmaceutical Co., LTD4a5c232d-5d29-2504-e063-6394a90ac9de2026-02-08WarningsExact identifier
application number: M017
ASSIELF NUMBING Topical AnorectalLIDOCAINEShenzhen Yuanbang International Logistics Co., Ltd4a5cb477-57ef-2a1d-e063-6394a90ac9ed2026-02-08WarningsExact identifier
application number: M017
Lidocaine Pain Relieve Gel-PatchPAIN RELIEVE GEL-PATCHHenan Kangdi Medical Devices Co., Ltd1e31b950-e990-e255-e063-6394a90a7d232026-02-07WarningsExact identifier
application number: M017
Herbal Knee PatchHERBAL KNEE PATCHHenan Kangdi Medical Devices Co., Ltd2a009059-b515-8214-e063-6294a90a4ed32026-02-07WarningsExact identifier
application number: M017
Flocean ANTI-ITCHBENZOCAINE 5%ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a493911-a846-5aa0-e063-6294a90a65ac2026-02-07WarningsExact identifier
application number: M017
daily solutions Ice Blue AnalgesicMENTHOL, UNSPECIFIED FORMGarcoa, Inc.4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e62026-02-06WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEShenzhen Wankelai E-commerce Co., Ltd.4a22562b-601e-97d7-e063-6394a90a5bca2026-02-06WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONESportpharm LLCee64ad1e-78db-4553-a3cf-b539b770fa262026-02-06WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINE 4%Sportpharm LLC1dd022b9-88ae-4737-88cc-fdb0ce0a83a32026-02-06WarningsExact identifier
application number: M017
Camphor plus Lidocaine Pain ReliefCAMPHOR, LIDOCAINEVeridian Healthcare4a2b73a8-c10c-85f9-e063-6294a90ac52c2026-02-06WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLRetail Business Services, LLC073c72fe-3171-4a4f-913a-d1b9630a1af32026-02-06Warnings, Adverse reactionsExact identifier
application number: M017
HealthWise Soothing Lidocaine Pain ReliefLIDOCAINE HCI 0.5%Veridian Healthcare4a2ec73e-7332-6f13-e063-6294a90a85062026-02-06WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70631-957-02706310957021 POUCH in 1 BOX (70631-957-02) > 2 g in 1 POUCH1 pouch2021-03-260000-00-00NoNoCurrent
70631-957-34706310957341 TUBE in 1 BOX (70631-957-34) / 100 g in 1 TUBE1 tube2024-04-160000-00-00NoNoCurrent