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 109 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Lidocaine Patch XLargeLIDOCAINERite Aid Corporationefa531c2-4956-e93a-e053-2995a90ae0ea2024-12-18WarningsExact identifier
application number: M017
Maximum Strength Pain Relief Lidocaine PatchLIDOCAINERite Aid Corporationbd31105a-f73f-2f57-e053-2995a90a59c02024-12-18WarningsExact identifier
application number: M017
Meijer Lidocaine Pain Relief Patch Assortment MediumLIDOCAINEMeijer Distribution Incab83b445-0e11-b985-e053-2995a90a02782024-12-18WarningsExact identifier
application number: M017
Meijer Lidocaine Pain Relief Patch Assortment LargeLIDOCAINEMeijer Distribution Incaa7f9bc8-0d56-5dde-e053-2a95a90af0e72024-12-18WarningsExact identifier
application number: M017
Meijer Lidocaine Pain Relief Patch Assortment SmallLIDOCAINEMeijer Distribution Incab85ce5a-8787-4317-e053-2a95a90a62bc2024-12-18WarningsExact identifier
application number: M017
MEIJER LIDOCAINE PAIN RELIEF BACK AND LARGE AREASLIDOCAINEMeijer Distribution Incb9e512e3-8337-1f44-e053-2a95a90a7fcb2024-12-18WarningsExact identifier
application number: M017
Hot and Cold Medicated PatchMENTHOLVeridian Healthcare67446b19-3296-42f1-9e5f-2bb7938017c02024-12-18WarningsExact identifier
application number: M017
Thera Care Hot and Cold Medicated PatchMENTHOLVeridian Healthcarec9c6eb07-39ef-4c87-b463-d1960abdf2022024-12-18WarningsExact identifier
application number: M017
HealthWise Lidocaine Pain reliefLIDOCAINEVeridian Healthcarece28a1d0-49f1-ed6f-e053-2a95a90a50db2024-12-18WarningsExact identifier
application number: M017
HealthWise Menstrual Pain Relief PatchMENTHOLVeridian Healthcareee62e44e-a09f-2e58-e053-2a95a90abe042024-12-18WarningsExact identifier
application number: M017
THERA CARE 24hrs Lidocaine PatchLIDOCAINE 4%Veridian Healthcareaa93e05e-46ce-3bc4-e053-2a95a90aa46c2024-12-18WarningsExact identifier
application number: M017
Caring Mills Relief Patch with LidocaineLIDOCAINE 4%Veridian Healthcaref161a8e2-b6df-27d7-e053-2995a90aa01c2024-12-18WarningsExact identifier
application number: M017
HealthWise Lidocaine and Menthol Pain ReliefLIDOCAINE AND MENTHOLVeridian Healthcarece2e9d9b-b4a4-ab61-e053-2a95a90a06422024-12-18WarningsExact identifier
application number: M017
MEIJER PAIN RELIEF PATCHESLIDOCAINEMeijer Distribution Incf591588e-467b-4c37-b0e1-c0be844220412024-12-18WarningsExact identifier
application number: M017
TheraCare Pain Relieving Patch with LidocaineLIDOCAINEVeridian Healthcaref93b00e1-06d6-9066-e053-6294a90ae89a2024-12-18WarningsExact identifier
application number: M017
Large Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEMeijer Distribution Incf2928904-a202-414a-b262-287a0a7bda932024-12-18WarningsExact identifier
application number: M017
Meijer Large Cold-Hot Medicated PatchesMENTHOLMeijer Distribution Incaf0e7609-c320-414a-9df6-dfb3b08c8b822024-12-18WarningsExact identifier
application number: M017
Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEMeijer Distribution Inc75c6fcd5-185c-4203-b604-19ce801c865f2024-12-18WarningsExact identifier
application number: M017
MEIJER PAIN RELIEF PATCHESLIDOCAINEMeijer Distribution Incaa5da66d-3ba9-4120-be35-44bec475761a2024-12-18WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%CVS Pharmacy8a9757e3-0bfc-a1e2-e053-2a95a90a6da32024-12-18WarningsExact 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