FDA.reportPublic FDA data

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 113 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Medicated Foot PowderMENTHOLVeridian Healthcare2916a0c3-2d66-d079-e063-6394a90acd6b2024-12-12WarningsExact identifier
application number: M017
Ease Your PainMENTHOLProximity Capital Partners LLC dba Asutra83366ae1-e1d9-2a30-e053-2a91aa0a1cc42024-12-12WarningsExact identifier
application number: M017
Natural Seal Itch Relief for KidsLIDOCAINEKericure Inc.31cc0c95-5864-4737-b085-8f58e00f4f052024-12-12WarningsExact identifier
application number: M017
Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin FormulaHYDROCORTISONE ACETATECombe Incorporated9b69fa24-02dd-43e4-a81f-9a37968d70992024-12-12WarningsExact identifier
application number: M017
VAGISIL Anti-Itch Medicated Creme Maximum StrengthBENZOCAINE AND RESORCINOLCombe Incorporatedbb73ebd7-ceb0-4b54-9e8f-77486d9037fb2024-12-12WarningsExact identifier
application number: M017
VAGISIL Anti-Itch Creme Regular StrengthBENZOCAINE AND RESORCINOLCombe Incorporateddd303ff8-0deb-4292-bfd8-5bda91f86d512024-12-12WarningsExact identifier
application number: M017
VAGISIL Anti-Itch Medicated Wipes Maximum StrengthPRAMOXINE HYDROCHLORIDECombe Incorporatedb848f53d-8aea-4efe-aa2c-009d5121fc332024-12-12WarningsExact identifier
application number: M017
Walgreens Cool and HeatMENTHOL 16%Walgreensce1585f4-ca65-8d0c-e053-2995a90a8e892024-12-11WarningsExact identifier
application number: M017
Walgreens Cool n HeatLIDOCAINE 4%Walgreensce1b21d6-7aa6-2b18-e053-2995a90a4c912024-12-11WarningsExact identifier
application number: M017
Walgreens Pain Burn Itch ReliefBENZOCAINE 20%, MENTHOL 0.5%Walgreenscc6e4b42-fdd8-6ff7-e053-2995a90a3d1d2024-12-11WarningsExact identifier
application number: M017
Pramoxine Itch reliefPRAMOXINE HCL 1%CVSe947694c-c122-0291-e053-2995a90ac39a2024-12-11WarningsExact identifier
application number: M017
Arthritis CreamTROLAMINE SALICYLATE 10%CVSd1663f50-479b-4d55-e053-2995a90a223f2024-12-11WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOL 4%CVSd1660d55-1ee0-7aa2-e053-2995a90a65792024-12-11WarningsExact identifier
application number: M017
CVS Muscle RubMENTHOL 10%, METHYL SALICYLATE 15%CVS Healthc72c9a95-4226-6d69-e053-2a95a90a8e1c2024-12-11WarningsExact identifier
application number: M017
BENGAY ULTRA STRENGTH NON-GREASYCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEKenvue Brands LLC0a41ec65-bd0b-4fc6-807d-74f353341cc72024-12-11WarningsExact identifier
application number: M017
Serum XLIDOCAINE HYDROCHLORIDEAO Biologix, LLCe07b6268-6400-6849-e053-2a95a90a8b3e2024-12-11WarningsExact identifier
application number: M017
PlusCBD Pain Cream (Penetrating) 2ozCAMPHOR, MENTHOLCV Sciences, Inc.ca39d327-6bf3-3408-e053-2a95a90af2d52024-12-11WarningsExact identifier
application number: M017
Blistex MedicatedDIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOLBlistex Inc.e95439d3-f12b-4c1c-999a-79f2ddba4cfb2024-12-11WarningsExact identifier
application number: M017
Blistex Foille Medicated First AidBENZOCAINE AND CHLOROXYLENOLBlistex Inc.e2eca808-e97b-43e0-aa51-7025cc61c7a82024-12-11WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEJ&A Digital Inc.ff95a536-35b3-4006-b43c-cce359e86aa92024-12-10WarningsExact 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