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 117 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MYCO Clinic Pain ReliefMENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions604a30c9-2306-47a1-bd31-94b63639dd902024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions0b489420-3b5c-43c5-aab4-0e3720acf9ce2024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsdd906129-a787-4352-856d-d7a915031a6e2024-11-20WarningsExact identifier
application number: M017
Walgreens Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDEWalgreens Company80d3031a-7fa9-4f5b-b85e-c7c6ef3148012024-11-20WarningsExact identifier
application number: M017
Anti-Itch Medicated Maximum StrengthBENZOCAINE AND RESORCINOLWalgreens Company7fd86dcb-edef-4d0d-b389-7ecea595fe672024-11-20WarningsExact identifier
application number: M017
Walgreens Pain ReliefBENZOCAINEWalgreens Company7cee7234-32cd-4bf3-8a6c-0882585eec7f2024-11-20WarningsExact identifier
application number: M017
Walgreens Advanced Scar GelADVANCED SCAR GELWalgreens Company2c040475-a124-485c-933e-66b452f5ab462024-11-20WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEClinic Pharma274611ea-7fc2-ba3f-e063-6294a90aa50f2024-11-19WarningsExact identifier
application number: M017
First Aid Only Sting Relief PadBENZOCAINEAcme United Corporation5087cbbd-1bbe-62ed-e054-00144ff8d46c2024-11-19WarningsExact identifier
application number: M017
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporation6bb9a782-2394-4c8c-e053-2991aa0a08d42024-11-19WarningsExact identifier
application number: M017
First Aid Only Sting ReliefBENZOCAINEAcme United Corporation697127d1-c02e-16d2-e053-2a91aa0a39fd2024-11-19WarningsExact identifier
application number: M017
First Aid Only Hydrocortisone 1% Anti-ItchHYDROCORTISONEAcme United Corporatione5597b11-b08e-99e1-e053-2a95a90a15a52024-11-19WarningsExact identifier
application number: M017
Equate Cold Therapy Pain Relieving Roll-on AnalgesicMENTHOL, UNSPECIFIED FORMWal-Mart Stores, Inc.4115f0ac-e12a-4e59-94f5-a47dcc7f87662024-11-18WarningsExact identifier
application number: M017
Equate Cold Therapy Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMWal-Mart Stores, Inc.ac6c2112-8692-4628-97d8-3a5a9f5097662024-11-18WarningsExact identifier
application number: M017
Equate Odor-Free Therapy Arthritis AnalgesicTROLAMINE SALICYLATEWal-Mart Stores, Inc.1d73e7b6-c7f9-4680-b3e3-a954b91e18632024-11-18WarningsExact identifier
application number: M017
First Aid Only BurnLIDOCAINE HYDROCHLORIDEAcme United Corporation9af39fcd-0a57-26d0-e053-2a95a90a99a02024-11-17WarningsExact identifier
application number: M017
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEAcme United Corporationcaa67a05-bdbd-c380-e053-2995a90a0bf12024-11-17WarningsExact identifier
application number: M017
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafewayc6b9c4e1-bab8-490d-8c00-c43377ad08572024-11-15WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreen Company1a9b8b4c-3e15-49e6-af91-76ed0dc0829e2024-11-15WarningsExact 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