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 91 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEStratus Pharmaceuticals Inc5eb6574c-2066-4390-befc-8e5d2dd6ede22025-06-12WarningsExact identifier
application number: M017
CHINESE RED TIGER LIDOCAINE PATCHES4% LIDOCAINE, 1%MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd36b9a7a2-5832-4ce5-e063-6294a90aed122025-06-12WarningsExact identifier
application number: M017
PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd375bc794-3289-e610-e063-6294a90a4f9b2025-06-12WarningsExact identifier
application number: M017
Methyl Salicylate 10% Pain RelievingMETHYL SALICYLATEPureTek Corporation376493eb-5142-db6d-e063-6294a90a1e732025-06-12WarningsExact identifier
application number: M017
Free and Pure Cold Therapy Pain ReliefMENTHOLWalgreen Co.22cbbffc-f876-411e-e063-6394a90a1b382025-06-12WarningsExact identifier
application number: M017
Methylten 25% Pain RelievingMETHYL SALICYLATEPureTek Corporation3767b97e-ab0c-ac26-e063-6394a90a00cf2025-06-12WarningsExact identifier
application number: M017
SPF 50 Mineral SunscreenZINC OXIDEInspec Solutions, LLC36af9a0a-536b-ee1a-e063-6394a90aace42025-06-11WarningsExact identifier
application number: M017
PLANTAR FASCIITIS Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd37570149-dae1-a4f2-e063-6294a90a32452025-06-11WarningsExact identifier
application number: M017
Diabecin CS CreamMENTHOL, CAPSAICINPuretek Corporation33ef2233-7a66-ee65-e063-6294a90ac55a2025-06-10WarningsExact identifier
application number: M017
KINKAN COOLDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLKINKANDO CO., LTD .82011efe-825c-4102-b6f1-59eff4c8040a2025-06-10WarningsExact identifier
application number: M017
MQUPIN Knee PatchKNEE PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.37438a70-dab7-ecb5-e063-6394a90afefb2025-06-10WarningsExact identifier
application number: M017
ORTHOGEL Menthol 3.5% Roll OnMENTHOLLiquidCapsule Manufacturing LLC99424327-67e9-43b5-a117-94c9643413c12025-06-07WarningsExact identifier
application number: M017
Lightning Pain ReliefMENTHOLEbanel Laboratories, Inc36edbc3f-501c-c1ea-e063-6394a90af6af2025-06-06WarningsExact identifier
application number: M017
FREEZE IT Menthol Roll OnMENTHOLLiquidCapsule Manufacturing LLC33094afe-db9d-4b92-8047-6dd611484fc92025-06-05WarningsExact identifier
application number: M017
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd55e6b09-0587-61a9-e053-2995a90afaf52025-06-05WarningsExact identifier
application number: M017
FREEZE IT MentholMENTHOLLiquidCapsule Manufacturing LLCde8d8007-5718-4fb4-a8c6-4650d2ca9c8f2025-06-05WarningsExact identifier
application number: M017
HEEL PAIN Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd36bacb5f-c1af-2e97-e063-6394a90afe5c2025-06-04WarningsExact identifier
application number: M017
Capsaicin 0.075% CreamCAPSAICINViolaCare, Inc.30911225-a6d7-4b2b-9005-b733373e28772025-06-04WarningsExact identifier
application number: M017
LidoGuardLIDOCAINE HCLViolaCare, Inc.531383aa-4f0f-4fe0-91f4-d809b39f160f2025-06-04WarningsExact identifier
application number: M017
HealthWise Lidocaine and MentholLIDOCAINE AND MENTHOLVeridian Healthcare36c27642-f913-1aad-e063-6294a90a43432025-06-04WarningsExact 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