MAG 5 PT WARMING FORMULA
- Product NDC
- 76348-511
- 11-digit product format
- 763480511
- Labeler code
- 76348
- Product ID
- 76348-511_574988ea-50c0-bcb0-e063-6294a90ad749
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- RENU LABORATORIES, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-03-19
- Substance
- MENTHOL
- Active strength
- 5.6 g/112g
- 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 | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 76348-511-05 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 76348-511-05 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 76348-511-05 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 76348-511-05 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 76348-511-05 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 76348-511-05 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 76348-511-05 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- MAG 5 PT WARMING FORMULA
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 5.6 g/112g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a499ac9b-0e8e-e23f-e053-2a95a90abe9a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 4d7a96d5-8256-4268-9a6c-25ea66d321fe | Product name | 1 | 20180814 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-03-27 | MAG 5 PT WARMING FORMULA RECOVERY CREAM |
| 2025-03-27 | MAG 5 PT WARMING FORMULA RECOVERY CREAM |
| 2025-01-30 | MAG 5 PT WARMING FORMULA RECOVERY CREAM |
| 2025-01-30 | MAG 5 PT WARMING FORMULA RECOVERY CREAM |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76348-511-04 | MAG 5 PT WARMING FORMULA | 112 g in 1 JAR | CREAM | 112 | 10 | |
| 76348-511-05 | MAG 5 PT WARMING FORMULA | 1 in 1 BOX | CREAM | 1 | 10 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Zylotrol | LIDOCAINE HCL 4%, MENTHOL 1% | Whitestone Products LLC | 0e32e9c0-ff5b-4e88-89b1-f5903cd98209 | 2023-10-16 | Warnings | M017 |
| Capsadyn | CAPSAICIN | Chorda Pharma, Inc | 07731045-0d2b-76b7-e063-6294a90af921 | 2023-10-11 | Warnings | M017 |
| WHITE FLOWER STRAIN RELIEF | CAMPHOR, MENTHOL AND METHYL SALICYLATE | HOE HIN PAK FAH YEOW MANUFACTORY LTD | 65282267-de63-453a-a686-f8752c71b9ef | 2023-10-02 | Warnings | M017 |
| WHITE FLOWER ANALGESIC BALM FLORAL SCENTED | CAMPHOR, MENTHOL AND METHYL SALICYLATE | HOE HIN PAK FAH YEOW MANUFACTORY LTD | 4e9cb5aa-b0aa-4a5c-b561-cc38437758d8 | 2023-10-02 | Warnings | M017 |
| NATUREANCE BODY BALM | CAMPHOR | EROS GLOBAL CORP | 05b84fd2-8d8f-9249-e063-6294a90ae29f | 2023-09-19 | Warnings | M017 |
| U ICE COLD | MENTHOL | UNIVERSAL DISTRIBUTION CENTER LLC | 752ef0cd-f12a-3b9e-e053-2991aa0abeb1 | 2023-09-01 | Warnings | M017 |
| Family Wellness Pain Relief with Lidocaine | PAIN RELIEF WITH LIDOCAINE | FAMILY DOLLAR (Family Wellness) | 3a18119f-6c75-4cea-a990-97cb8a9589d4 | 2023-08-29 | Warnings | M017 |
| Bactine Max Antibiotic and Lidocaine Max Pain Relief | LIDOCAINE | WellSpring Pharmaceutical Corporation | 71300df9-6113-4f25-93ca-28ad7e7f79de | 2023-06-08 | Warnings | M017 |
| Bactine Max Lidocaine Roll-on 2.5oz | LIDOCAINE | WellSpring Pharmaceutical Corporation | 09b32a98-9131-451e-87a6-81a1e4ed7ec5 | 2023-04-25 | Warnings | M017 |
| Icy Hot Pro Dry | CAMPHOR, MENTHOL | Chattem, Inc. | 4de1bc29-d166-4599-9e75-5f841bf20967 | 2023-03-01 | Warnings | M017 |
| Icy Hot Vanishing Scent | MENTHOL | Chattem, Inc. | e2092016-9741-433d-92e6-74bfddadb72c | 2022-09-29 | Warnings | M017 |
| New Terocin | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | Alexso, Inc | 5dbd5fc0-a27e-4979-aca7-28f73096fd5f | 2022-08-18 | Warnings | M017 |
| FIRSTAR Sting Relief Pad | BENZOCAINE | JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. | 0e491a7a-4204-439f-862d-741cbc0be9fd | 2021-07-06 | Warnings | M017 |
| Arthritis Relief GoodSense | TROLAMINE SALICYLATE | Geiss, Destin & Dunn, Inc | a253730a-2187-07de-e053-2a95a90a9877 | 2020-04-02 | Warnings | M017 |
| Aloe Cort | HYDROCORTISONE | Topiderm, Inc. | 789a6669-3320-4558-8d6f-ab255db50d8d | 2019-09-17 | Warnings | M017 |
| Eagle Brand Medicated Roll On Refresh | CAMPHOR, MENTHOL | Borden Company (Private) Limited | 567b6820-fb52-630e-e063-6294a90a8bf8 | 2015-07-01 | Warnings | M017 |
| Eagle Brand Medicated Oil Aromatic | CAMPHOR, MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | 54e45d89-e8c3-6fc3-e063-6394a90aac4e | 2015-06-15 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76348-511-04 | 76348051104 | 112 g in 1 JAR | 112 g | Historical | |||
| 76348-511-05 | 76348051105 | 1 JAR in 1 BOX (76348-511-05) / 112 g in 1 JAR (76348-511-04) | 1 jar | 2019-03-19 | No | No | Current |