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.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 70631-957 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | ||
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 70631-957 | 70631-957-02 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 70631-957 | 70631-957-34 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | 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 |
|---|---|
| METHYL SALICYLATE | 125 mg/g |
| MENTHOL | 20 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Leader Burn Relief | LIDOCAINE | Cardinal Health | f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2 | 2024-02-06 | Warnings | M017 |
| Pain Relieving Petro Carbo | PHENOL | J.R. Watkins, LLC. | 050cf17d-3be7-45b9-8524-ad82af309a0e | 2024-02-06 | Warnings | M017 |
| White Cream | CAMPHOR (NATURAL) AND TURPENTINE OIL | J.R. Watkins, LLC. | e4de0734-59d5-478c-86ea-66fc2ba003e7 | 2024-02-05 | Warnings | M017 |
| Pain Relieving Roll-On | MENTHOL, UNSPECIFIED FORM | Safetec of America, Inc. | 80118260-9c88-402d-9a90-ecfe62b4b54f | 2024-02-05 | Warnings | M017 |
| Pain Relieving | MENTHOL, UNSPECIFIED FORM | Safetec of America, Inc. | df512ce6-ce1b-434d-9571-fb2e1d76e1d0 | 2024-02-05 | Warnings | M017 |
| Pain Relieving | MENTHOL | Safetec of America, Inc. | 52ebf64d-095f-467e-bf51-dd8d33b58c7d | 2024-02-05 | Warnings | M017 |
| Itch Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Safetec of America, Inc. | 4f4c801b-d894-4fa3-b024-6ca41a5f2a95 | 2024-02-04 | Warnings | M017 |
| Analgesic | MENTHOL | Safetec of America, Inc. | 79e3b0e7-4ba5-4b9d-a980-5b6f18dba802 | 2024-02-04 | Warnings | M017 |
| HAV EZ Penetrating Pain Relief | MENTHOL | PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC | 70006efc-9cc8-4490-b28c-fcb23b1737c4 | 2024-02-01 | Warnings | M017 |
| Rugby Capsaicin External Analgesic | CAPSAICIN | Proficient Rx LP | 7c733a30-5002-49e7-a6bd-7737a1d2461e | 2024-02-01 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Proficient Rx LP | ccb62898-b614-45b9-95ea-23e5e31893a8 | 2024-02-01 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE | Proficient Rx LP | 0b26d92f-9d0e-46d4-a8bc-75d6da5f6199 | 2024-02-01 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Proficient Rx LP | c57d5f8e-5934-4cbb-999a-cdd55e5b105f | 2024-02-01 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Proficient Rx LP | 47e9fe84-bd0c-40ea-85de-e950bcacc557 | 2024-02-01 | Warnings | M017 |
| Joint and Muscle Pain | MENTHOL | Shaklee Corporation | 3943824f-1f4f-4d6f-bd73-0b1be02162a5 | 2024-01-30 | Warnings | M017 |
| Mirakel Pain Relief Roll-On | LIDOCAINE HCL | Sanvio, Inc. | 102f3618-13ad-37e3-e063-6294a90a8086 | 2024-01-30 | Warnings | M017 |
| Blistex Lip Medex | PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOL | Blistex Inc. | 8ad39005-9419-4f1a-a1ae-2f76d212455e | 2024-01-26 | Warnings | M017 |
| Point Relief Cold Spot Pain Relieving | MENTHOL | Fabrication Enterprises | ad5d6f04-15e6-4548-95c2-32271c186bc1 | 2024-01-25 | Warnings | M017 |
| MIND BODY MATRIX PAIN RELIEF | MENTHOL | Functional Energetic, Inc. | 3667dd0d-942e-4101-ba98-cb013ae77cf5 | 2024-01-25 | Warnings | M017 |
| SUPER WHITE STUFF Pain Relief | MENTHOL | BLUE SPRING WELLNESS | e6d27df5-118c-4c6d-86e8-7b4401a39c76 | 2024-01-23 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70631-957-02 | 70631095702 | 1 POUCH in 1 BOX (70631-957-02) > 2 g in 1 POUCH | 1 pouch | 2021-03-26 | 0000-00-00 | No | No | Current |
| 70631-957-34 | 70631095734 | 1 TUBE in 1 BOX (70631-957-34) / 100 g in 1 TUBE | 1 tube | 2024-04-16 | 0000-00-00 | No | No | Current |