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 |
|---|---|---|---|---|---|---|
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | eb0cfde0-c463-e9b5-e053-2a95a90a1924 | 2024-01-15 | Warnings | M017 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | eb0cce4b-c70a-1b2d-e053-2995a90aa4aa | 2024-01-15 | Warnings | M017 |
| Oral Pain Relief Gel | BENZOCAINE 20% | Sled Distribution, LLC | e7391302-831e-14dc-e053-2a95a90ac236 | 2024-01-15 | Warnings | M017 |
| FIRST SHIELD | LIDOCAINE HCI | Ever Ready First Aid | e022bf8f-3dd8-de22-e053-2995a90a219b | 2024-01-15 | Warnings | M017 |
| Flexigen | MENTHOL 1.25% | Derma Care Research Labs, LLC | e9ae2682-59b4-e796-e053-2995a90af921 | 2024-01-15 | Warnings | M017 |
| Vita-P Oral and Nasal | MENTHOL 1% | Beijing HKKY Medical Tech. Co., Ltd. | 537c3843-1c92-41c6-b724-52701bbddeab | 2024-01-13 | Warnings | M017 |
| Caring mill Lidocaine Aloe Gel Burn and Pain Relief | LIDOCAINE HYDROCHLORIDE | FSA Store Inc. | 0ec20c87-1681-dd23-e063-6394a90a291c | 2024-01-12 | Warnings | M017 |
| Cool n Heat | COOL N HEAT | NeilMed Pharmaceuticals, Inc. | a24cde17-280b-8358-e053-2a95a90af67d | 2024-01-11 | Warnings | M017 |
| NeilMed Anti-Itch | ANTI-ITCH SPRAY | NeilMed Pharmaceuticals Inc. | b3d34d9e-85d9-df4e-e053-2a95a90ac8d9 | 2024-01-11 | Warnings | M017 |
| NeilMed Hot and Cold Pain Relief | PAIN RELIEF SPRAY | NeilMed Pharmaceuticals Inc. | b3d02111-7499-c2d4-e053-2a95a90ae1de | 2024-01-11 | Warnings | M017 |
| Cooling Itch Relief | COOLING ITCH RELIEF | NeilMed Pharmaceuticals, Inc | a24bdea0-18e8-8a5e-e053-2995a90acea2 | 2024-01-11 | Warnings | M017 |
| Lightning X Burn | LIDOCAINE | Nantong Health & Beyond Hygienic Products Inc. | 0e69a971-0c6e-6ebe-e063-6394a90a0b33 | 2024-01-08 | Warnings | M017 |
| Theraworx Pain Relief Roll-On with Lidocaine for Diabetics | LIDOCAINE HYDROCHLORIDE | AVADIM HOLDINGS, INC. | e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29 | 2024-01-08 | Warnings | M017 |
| 2nd CHANCE MOBILITY Pain Relief | HISTAMINE DIHYDROCHLORIDE | ALPHA NUTRITION, LLC | 575097ac-9fc9-4391-99d1-dff9b34817e3 | 2024-01-08 | Warnings | M017 |
| Tiger Balm Arthritis Rub | CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM | Haw Par Healthcare Ltd. | 80932288-4797-40d3-aa8a-6af686fb67ad | 2024-01-08 | Warnings | M017 |
| OPRAVA | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Biological M.D. Solutions LLC | 05552560-e283-5eba-e063-6294a90a65f7 | 2024-01-06 | Warnings | M017 |
| MED O-3 BIO- | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Biological M.D. Solutions LLC | 02707552-03d9-3ad2-e063-6294a90a3472 | 2024-01-06 | Warnings | M017 |
| Sumifun Knee Relieving Patch | KNEE RELIEVING PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 0e7e73ec-ab33-9235-e063-6394a90ad950 | 2024-01-06 | Warnings | M017 |
| Lidocaine Numbing Cream | LIDOCAINE | YYBA Corp | de6dc194-c6ef-4cb5-be3f-e772ace9abaf | 2024-01-03 | Warnings | M017 |
| Equate Vagicaine | 20% BENZOCAINE AND 3% RESORCINOL CREAM | Walmart Inc. | 0cdc9323-f5c3-468c-a7ae-83dfd2d76626 | 2024-01-03 | 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 |