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 38 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Muscle and Joint Gel Vanishing ScentMENTHOL 2.5%Veridian Healthcare494d2a85-45a8-12a2-e063-6294a90a391b2026-01-26WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINETrifecta Pharmaceuticals USA, LLC.493c09d0-16d7-7413-e063-6394a90aa0522026-01-26WarningsExact identifier
application number: M017
Topcare Medicated Pain Relieving Patch 60ctTOPCARE PAIN RELIEF PATCH EXTRA STRENGTHTopco Associates LLC4953c12b-ca6d-d21e-e063-6294a90ac9902026-01-26WarningsExact identifier
application number: M017
Dr SabharwalsMENTHOL 5% PATCHDr. Sabharwal's Wound Care1025b986-a1e5-701d-e063-6294a90a33fd2026-01-24WarningsExact identifier
application number: M017
Target Up and Up Pain Relief Menthol Topical AnalgesicMENTHOLTarget Corporation4910f32f-c639-0215-e063-6394a90a1c7b2026-01-23WarningsExact identifier
application number: M017
RapidolHYDROCORTISONEPharmadel LLC19a1f1e2-bc6b-7153-e063-6294a90ab1152026-01-23WarningsExact identifier
application number: M017
CVS 9083 Maximum Strength Lidocaine 4 Pain Relief Patch 1ct LargeLIDOCAINECVS PHARMACY, INC4914965f-1164-e20e-e063-6294a90ac2212026-01-23WarningsExact identifier
application number: M017
THE GOO MEDICATED PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAPSM PERFORMANCE, LLCdb4c321c-8cdc-5a11-e053-2995a90a91a12026-01-23WarningsExact identifier
application number: M017
Dr SabharwalsLIDOCAINE 4% AND MENTHOL 1% PATCHDr. Sabharwal's Wound Care10249d0f-5ee1-6892-e063-6394a90a967e2026-01-23WarningsExact identifier
application number: M017
Easment DMSO creamMENTHOL 1.00%Easment LLC48f5544e-1cfd-864a-e063-6394a90a71f12026-01-22WarningsExact identifier
application number: M017
Aveeno 1% Hydrocortisone Anti-Itch CreamHYDROCORTISONEKenvue Brands LLC1ac0ac4e-af76-9a3e-e063-6394a90a12692026-01-22WarningsExact identifier
application number: M017
RAYO ACTIVE ICEMENTHOL, CAMPHORQuimicas Handal de Centroamerica SA de CV09e4a36b-020a-c5b1-e063-6394a90a3e312026-01-22WarningsExact identifier
application number: M017
X-Treme FreezeCOLD THERAPY GELDynarex Corporation79f0802f-03ad-bf8f-e053-2991aa0ae4b52026-01-22WarningsExact identifier
application number: M017
Anti ItchHYDROCORTISONEHyVee Incae31f1f5-db70-45cf-850e-67bfe68607482026-01-21WarningsExact identifier
application number: M017
ULTRA RELIEFMENTHOL, CAMPHORCHEMCO CORPORATION48ea80cf-af54-ce5f-e063-6394a90ac4932026-01-21WarningsExact identifier
application number: M017
Healthy Back Institute Rub On ReliefANALGESICEagle Labs Inc.17dff3c1-3c0b-16f6-e063-6394a90a3c052026-01-21WarningsExact identifier
application number: M017
Pain ReliefANALGESICFullstack Fulfillment2a433cee-8b6f-c280-e063-6394a90ae25a2026-01-21Exact identifier
application number: M017
Walgreens Anti Itch CreamANTI ITCH CREAMWalgreens Companyb545553a-283a-48af-adc5-763758a9ff242026-01-21WarningsExact identifier
application number: M017
CVS Health Maximum Strength Lidocaine Pain Relief Cream Plus MentholLIDOCAINE HCL, MENTHOLCVS Pharmacy8aaffa3f-f82f-470c-902d-f366f1a663052026-01-21WarningsExact identifier
application number: M017
LIGHTS Instant Sting Relief PadBENZOCAINELights Medical Manufacture Co., Ltd.28dd82a7-f360-a022-e063-6394a90a3a762026-01-21WarningsExact 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