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 48 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nufabrx Elbow SleeveCAPSAICINNufabrx LLC473004cd-f7f9-3c68-e063-6294a90a5b8a2025-12-30WarningsExact identifier
application number: M017
Nufabrx Leg SleeveCAPSAICINNufabrx LLC473015ed-3e0f-6eae-e063-6294a90a4c742025-12-30WarningsExact identifier
application number: M017
Nufabrx Arm SleeveCAPSAICINNufabrx LLC472ef560-1ed6-c912-e063-6394a90aaa1c2025-12-30WarningsExact identifier
application number: M017
Nufabrx Shin SleeveCAPSAICINNufabrx LLC4730bf64-ea0c-ca8d-e063-6394a90af5422025-12-30WarningsExact identifier
application number: M017
Nufabrx Ankle SleeveCAPSAICINNufabrx LLC4730d164-9027-fff2-e063-6394a90a42802025-12-30WarningsExact identifier
application number: M017
Nufabrx Knee SleeveCAPSAICINNufabrx LLC473098ca-02f1-c287-e063-6394a90a37e12025-12-30WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINELiberty Procurement, In2d381c48-402f-4e46-81b2-41a184139a612025-12-30WarningsExact identifier
application number: M017
Thera Care Pain Relief Menthol PatchsMENTHOLVeridian Healthcare1faa1d4f-b7fb-4f36-aef1-2fedde114b8e2025-12-30WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINE PAIN RELIEFAllegiant Health7f715144-f0c8-48fc-a22d-eac85759c66a2025-12-30WarningsExact identifier
application number: M017
ZIKS ARTHRITIS PAIN RELIEFZIKS ARTHRITIS PAIN RELIEFNnodum Pharmaceuticals5dd4fefc-b70a-4850-819c-1cca6f28aa972025-12-29WarningsExact identifier
application number: M017
Ted and Gregs Pain Rub with Resveratrol Topical AnalgesicMETHYL SALICYLATETed and Greg's Inc.c699438d-595d-4711-801b-51e960aa36682025-12-29WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain Combo PackMENTHOLWISE CONSUMER PRODUCTS CO.47199677-e04c-768b-e063-6294a90a35242025-12-29WarningsExact identifier
application number: M017
Witch HazelWITCH HAZELCVS HEALTHb8b79e8d-9c84-1700-e053-2995a90af5bd2025-12-29WarningsExact identifier
application number: M017
WALGREENS BURNLIDOCAINE HYDROCHLORIDEWALGREENSb61e6d73-4f41-ef50-e053-2a95a90a0fc62025-12-29WarningsExact identifier
application number: M017
CVS cold and HotMENTHOL 16%CVSd1676df9-530f-1664-e053-2995a90a5b642025-12-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCfa956b6a-1712-4f7a-9490-11866dcd17c82025-12-29WarningsExact identifier
application number: M017
Frankincense and Myrrh Nerve Combo PackMENTHOLWise Consumer Products471d815c-1c34-e0f8-e063-6294a90aca782025-12-29WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLNatures Formulae Health Products Ltd.781d3c8d-7b70-e973-e053-2991aa0aaa782025-12-29WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLNatures Formulae Health Products Ltd.781dfd66-f006-a2d7-e053-2991aa0a170c2025-12-29WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLNatures Formulae Health Products Ltd.781d53cf-b3df-3e2b-e053-2a91aa0a7dcd2025-12-29WarningsExact 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