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 77 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DR AMIN JAVID Botanical-Complex Pain-Relieving Balm, 30 ml/1.0 fl ozMENTHOL, CAMPHOR, METHYL SALICYLATE, CAPSICUM OLEORESIN (CONTAINING CAPSAICIN)BH GLOBAL HOLDINGS LLC1ddddbb6-2d01-c894-e063-6394a90acd582025-10-01WarningsExact identifier
application number: M017
Tylenol Precise Pain Relieving Lidocaine 4%LIDOCAINEKenvue Brands LLC36a95afd-97e5-2271-e063-6394a90aea182025-09-30WarningsExact identifier
application number: M017
Capsaicin HeatCAPSAICINUniversal Distribution Center LLCb3b40f77-3b0b-4111-968b-f3a87a5701fa2025-09-29WarningsExact identifier
application number: M017
Caring Mills Menthol 4% Roll-OnMENTHOLVeridian Healthcaref4308c74-0860-4265-aeaf-a01301cca27a2025-09-29WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED LARGEMENTHOLUniversal Distribution Center LLCd6780230-aa96-4055-b054-be41358568b62025-09-29WarningsExact identifier
application number: M017
COLD AND HOT MEDICATEDMENTHOLUniversal Distribution Center LLCc19aa620-401d-43c4-804c-3611cc39e9f22025-09-29WarningsExact identifier
application number: M017
UniShield First Aid BurnLIDOCAINE HCLUnishieldf729c557-da4b-3fb5-e053-6394a90a41962025-09-28WarningsExact identifier
application number: M017
Xpect HydrocortisoneHYDROCORTISONECintas Corporation45ef9be4-54c4-4d85-966b-27708313ded42025-09-26WarningsExact identifier
application number: M017
Zhuifeng Gao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD3f12da60-26d1-4407-8e02-c3213ea3ad2a2025-09-26WarningsExact identifier
application number: M017
Gutong Tiegao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD5a5c3759-90e0-4a93-99cf-ddbf00aba10d2025-09-26WarningsExact identifier
application number: M017
Zhuanggu Gao Pain RelievingMENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTDe3e98530-ce4d-47b9-9383-3088814034eb2025-09-26WarningsExact identifier
application number: M017
GUTONG TIEGAO PAIN RELIEVINGCAMPHOR AND MENTHOLGUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD3adfac16-ea7b-47df-89f5-91bbd09c4fe12025-09-26WarningsExact identifier
application number: M017
Xpect Sting WipesBENZOCAINE 6%Cintas Corporationfeeae00d-e266-4ae4-90d2-524da38fa8132025-09-26WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreens Company0b4053a8-6c1c-621d-e063-6394a90a4f562025-09-25WarningsExact identifier
application number: M017
Unishield 1%HYDROCORTISONEUnishield4871a67f-fbb8-4a6b-ace4-d343490289082025-09-24WarningsExact identifier
application number: M017
Xpect Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDECintas Corporationa373b2c3-5c58-4b64-9358-bdf42dfce08c2025-09-24WarningsExact identifier
application number: M017
Xpect Burn CareBURN CARECintas Corp3665eb99-9602-4949-8af4-3ce7ed24303c2025-09-23WarningsExact identifier
application number: M017
Sheffield Arthritis and Muscle Pain ReliefCAPSICUM OLEORESINSheffield Pharmaceuticals LLC80a1bc65-2986-491f-a062-307d28b08ccb2025-09-22WarningsExact identifier
application number: M017
TheraCare Roll-on Menthol 16% Pain Relief LiquidMENTHOLVeridian Healthcared932050d-2a9a-4a5e-b45d-0a7a864582e02025-09-22WarningsExact identifier
application number: M017
TheraCare Roll-on Menthol 4% Pain ReliefMENTHOLVeridian Healthcarefa121e5f-94b5-4c1d-9c4e-85bb8ede39452025-09-22WarningsExact 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