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 42 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cortizone 10 Fast Acting Itch Relief CoolingHYDROCORTISONEChattem, Inc.01cd77e3-380f-4487-ae6e-3ac45355d8a42026-01-14WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd0174411c-1b10-4298-b820-87b24065b1182026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Intensive Healing for EczemaHYDROCORTISONEChattem, Inc.31dc0f1f-ddd8-41dc-b669-b24655634d552026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Overnight CremeHYDROCORTISONEChattem, Inc.ef2eda7e-d6a8-47e3-9d80-6074af6773dc2026-01-14WarningsExact identifier
application number: M017
CVS Pain Relief Lavender ScentMENTHOL 4%CVS484b0833-9f8a-f155-e063-6294a90a18692026-01-13WarningsExact identifier
application number: M017
EARTHS CARE ANTI-ITCHCAMPHOR (NATURAL), MENTHOLDLC Laboratories, Inc.d1eabb5f-7086-4ff0-a398-3703c9ecd4412026-01-13WarningsExact identifier
application number: M017
HealthWise Cold Therapy Menthol Pain ReliefMENTHOLVeridian Healthcare25e3d9cd-6ba3-4e06-8853-324b9d6692482026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.1ac2ed54-194c-4de2-8e7f-6e74ca32aa402026-01-13WarningsExact identifier
application number: M017
Pain Release Joint and Arthritis CreamMENTHOLSaje Natural Business Inc.18b24d75-17f7-1a35-e063-6394a90a55e02026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.a32b0950-3467-4e37-988d-104836af59712026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.92eec6e7-0367-43c6-bd28-1762390a71142026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.481a493b-0620-46ac-8228-e9964b7eb24b2026-01-13WarningsExact identifier
application number: M017
RestoralMENTHOLSaje Natural Business Inc.5b6176c1-9ed9-1950-e053-2a91aa0a434e2026-01-13WarningsExact identifier
application number: M017
Aspercreme Lidocaine with Eucalyptus Essential OilLIDOCAINE HCLChattem, Inc.03e247b4-a2e2-4354-a018-880f1bc987fd2026-01-13WarningsExact identifier
application number: M017
Aspercreme Lidocaine Foot (Diabetic)LIDOCAINE HYDROCHLORIDEChattem, Inc.2c33d15e-5032-46d9-bd98-5abc7df3bbe52026-01-13WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Essential Oils Rosemary MintLIDOCAINEChattem, Inc.9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab2026-01-13WarningsExact identifier
application number: M017
Capzasin HP Arthritis Pain ReliefCAPSAICINChattem, Inc.345c9159-0efe-436b-9068-3b717678936b2026-01-13WarningsExact identifier
application number: M017
Capzasin Quick ReliefCAPSAICIN AND MENTHOLChattem, Inc.d6c313a3-8dc6-4231-95b6-ac9399e1c1be2026-01-13WarningsExact identifier
application number: M017
Aspercreme Pain RelievingTROLAMINE SALICYLATEChattem, Inc.97dd587b-ecc3-4b4b-a116-6355d3c6ea6d2026-01-13WarningsExact identifier
application number: M017
Dr Wellskin Numbing Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD482f25cc-dee3-c3b6-e063-6294a90a86742026-01-12WarningsExact 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