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 |
|---|---|---|---|---|---|---|
| Methyl Salicylate | METHYL SALICYLATE | PHARMACURE LLC | 66b13044-69d2-4559-9e65-8a4c601c077a | 2025-10-06 | Warnings | M017 |
| Methyl Salicylate | METHYL SALICYLATE | PHARMACURE LLC | f119a1bd-095f-41f5-86d5-c0ee4f19fd2c | 2025-10-06 | Warnings | M017 |
| LIDOCAINE | LIDOCAINE | PHARMACURE LLC | 31d5e5c9-6ec4-4496-8a4c-cca39a2cbe32 | 2025-10-06 | Warnings | M017 |
| Tempo cool | MENTHOL | The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E | bd642389-6d03-4e09-a71c-312fb90eae89 | 2025-10-06 | Warnings | M017 |
| Menthopatch Hot | MENTHOL , CAPSICUM EXTRACT | THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID | 3d289be3-c237-4065-a8ac-e8c2e51b76a5 | 2025-10-06 | Warnings | M017 |
| Mentho patch cool | MENTHOL | THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID | 02251a4a-fc6f-42c9-a244-6f4835de5edd | 2025-10-06 | Warnings | M017 |
| Feminine Anti-Itch Creme | BENZOCAINE, RESORCINOL | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | aa6cc963-dc60-5222-e053-2995a90acaf6 | 2025-10-06 | Warnings | M017 |
| TheraCare 2% Diphenhydramine Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Veridian Healthcare | 5999b677-63dd-49c6-b5b8-7b3c117ecc5c | 2025-10-06 | Warnings | M017 |
| HealthWise Pain Relief | MENTHOL | Veridian Healthcare | 06be5331-7a1e-4ab3-9f17-2d350bd4b890 | 2025-10-02 | Warnings | M017 |
| equate Burn Relief | LIDOCAINE HYDROCHLORIDE | Walmart Inc | a90cbd92-80a5-4463-8152-b83165121a6f | 2025-10-02 | Warnings | M017 |
| AsperFlex HOT | CAMPHOR, MENTHOL, METHYL SALICYLATE | Akron Pharma Inc. | a6cb0656-8866-44ff-b40c-73655ff68721 | 2025-10-02 | Warnings | M017 |
| AsperFlex Original Maximum Strength | MENTHOL | Akron Pharma Inc. | d766c61e-c48b-4aff-97b0-678159479e03 | 2025-10-02 | Warnings | M017 |
| HealthWise Feminine Anti-Itch Cream | BENZOCAINE, RESORCINOL | Veridian Healthcare | 1f9110da-f448-8e20-e063-6294a90a4275 | 2025-10-02 | Warnings | M017 |
| PROSTAT FIRST AID Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | dc704403-e2aa-47f7-a7f4-f6afe1547ca8 | 2025-10-01 | Warnings | M017 |
| PROSTAT FIRST AID Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | e02558a9-fe2b-4f28-9fd3-7308f859d759 | 2025-10-01 | Warnings | M017 |
| FL Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | 4dc0d579-ab42-4ea5-9788-5e54d7d318a3 | 2025-10-01 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), WHITE PETROLATUM | Carma Laboratories, Inc. | c7a7626c-cf82-4301-af79-c5e85367e777 | 2025-10-01 | Warnings | M017 |
| Viaderma Calm Anti-Itch | HYDROCORTISONE | ViaDerma Distribution, Inc. | 7afa2ccd-bfc6-48fc-9a14-a0c6d645844e | 2025-10-01 | Warnings | M017 |
| AsperFlex Advance | CAMPHOR, MENTHOL, METHYL SALICYLATE | Akron Pharma Inc. | d23d7f2b-4dcd-4c31-9d12-340f233018b4 | 2025-10-01 | Warnings | M017 |
| HEATING PAIN RELIEF | METHYL SALICYLATE, MENTHOL | SUNSET NOVELTIES, INC | 4024d604-c8c7-2d73-e063-6294a90a2e80 | 2025-10-01 | 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 |