MED O-3 BIO-
- Product NDC
- 83538-101
- 11-digit product format
- 835380101
- Labeler code
- 83538
- Product ID
- 83538-101_0e49fac4-c072-beb0-e063-6294a90ac96f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- METHYL SALICYLATE, MENTHOL, CAPSAICIN
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Biological M.D. Solutions LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-08-08
- Substance
- METHYL SALICYLATE; CAPSAICIN; MENTHOL
- Active strength
- 10; .03; 1 g/100mL; g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 83538-101-18 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 83538-101-18 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 83538-101-18 | 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
- MED O-3 BIO-
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METHYL SALICYLATE | 10 g/100mL |
| CAPSAICIN | .03 g/100mL |
| MENTHOL | 1 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| LAV5U5022Y | Internal UNII lookup |
| S07O44R1ZM | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2644111 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 02707552-03d9-3ad2-e063-6294a90a3472 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83538-101-18 | 2025-02-01 | C162847 | 48780-1 | 2cef2736-898a-d83d-e063-dadaa90ab31f | BIOLOGICAL MD SOLUTIONS (as PLD) - Med O-3 Bio-Cream (83538-101) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83538-101-18 | MED O-3 BIO- | 237 mL in 1 BOTTLE | CREAM | 237 | 2 |
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 |
|---|---|---|---|---|---|---|
| Satogesic | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Sato Pharmaceutical Co., Ltd. | cb000134-92a4-4304-8ef0-0347190e1414 | 2026-07-31 | Warnings | M017 |
| Satogesic Hot | CAPSAICIN | Sato Pharmaceutical Co., Ltd. | 16b47cb5-ea5f-4514-9a89-141ee4cc60f8 | 2026-07-31 | Warnings | M017 |
| Satohap Cool and Hot Pads | CAMPHOR, CAPSAICIN, MENTHOL | Sato Pharmaceutical Co., Ltd. | b6bf1eab-4ab9-f500-e053-2995a90a8d7b | 2026-07-31 | Warnings, Adverse reactions | M017 |
| SATOHAP COOL and HOT | CAMPHOR, CAPSAICIN, MENTHOL | Sato Pharmaceuticals Co., Ltd. | 232a4c76-1a0c-2f4b-e063-6394a90a8849 | 2026-07-31 | Warnings, Adverse reactions | M017 |
| Cortizone 10 Itch Relief Massaging Rollerball | HYDROCORTISONE | Chattem, Inc. | 1e27682c-f856-41f1-9935-37540960a4c7 | 2026-07-31 | Warnings | M017 |
| Aspercreme with Lidocaine Dry | LIDOCAINE | Chattem, Inc. | 008abaaa-5e12-4246-a7f5-66f3966acf28 | 2026-07-30 | Warnings | M017 |
| ACOLYE Lidocaine Cream Topical Analgesia Cream | LIDOCAINE,MENTHOL | Guangdong Aimu Biological Technology Co., Ltd | 57deebf7-52f1-4256-e063-6294a90a75d5 | 2026-07-30 | Warnings | M017 |
| Icy Hot Performance No-Mess Pain Relief Cream | MENTHOL 16%, CAMPHOR 11% | Chattem, Inc. | 5e3e272a-c001-4f57-9535-521ccc85ae65 | 2026-07-30 | Warnings | M017 |
| Auixudin Lidocaine Pain Relief Gel-Patch | LIDOCAINE PAIN RELIEF GEL-PATCH | Henan Enokon Medical Instrument Co., Ltd. | 57bc7b9e-e2f7-724b-e063-6394a90ab36f | 2026-07-29 | Warnings | M017 |
| Jinfahe Lidocaine Pain Relief Patch | LIDOCAINE PAIN RELIEF PATCH | Henan Enokon Medical Instrument Co., Ltd. | 57bcd9c5-767e-b634-e063-6394a90a2878 | 2026-07-29 | Warnings | M017 |
| Maximun Strength Lidocaine Patch Plus Menthol | LIDOCAINE, MENTHOL | Meijer Distribution Inc | d0468514-58ea-4d8f-b634-a65bf95c0316 | 2026-07-29 | Warnings | M017 |
| Oudetas Lidocaine Cream | LIDOCAINE CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 57ca9220-2778-790a-e063-6294a90af506 | 2026-07-29 | Warnings | M017 |
| Aspercreme Lidocaine No-Mess plus Lavender | LIDOCAINE HCL | Chattem, Inc. | 3948a3d2-ce04-4703-8709-211e75c9c38d | 2026-07-29 | Warnings | M017 |
| Aspercreme Professional Cream | LIDOCAINE HCL 4% | Chattem, Inc. | ef297864-5917-4645-8ec7-f2bc49e037e8 | 2026-07-29 | Warnings | M017 |
| LidoPro | LIDOCAINE AND MENTHOL | Clinic Pharma | cdfd6b39-b430-4e95-a0f7-682cf3d78b52 | 2026-07-28 | Warnings | M017 |
| LidoPro Patch (Lidocaine 4%, Menthol 1%) | LIDOCAINE AND MENTHOL PATCH | Clinic Pharma | 2b4d2105-b7ad-2695-e063-6394a90a999b | 2026-07-28 | Warnings | M017 |
| HEMPE Ice Muscle and Joint Gel | MENTHOL | Healthcare International Research Limited | 57aec922-1de4-c579-e063-6394a90af6c8 | 2026-07-28 | Warnings | M017 |
| Earths Care Pain Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | DLC Laboratories, Inc. | 5c3976da-a6cb-4b94-ae41-3e86b1ab13cb | 2026-07-28 | Warnings | M017 |
| Muscle Rub Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Preferred Pharmaceuticals Inc. | 9e7568b6-52ae-4f7a-9bfd-503fd80a297e | 2026-07-28 | Warnings | M017 |
| Aspercreme Lidocaine with Rosemary and Mint | LIDOCAINE HYDROCHLORIDE | Chattem, Inc. | 9d40bfea-85d0-4943-83e9-0c16e79a011c | 2026-07-28 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2644111 | capsaicin 0.03 % / menthol 1 % / methyl salicylate 10 % Topical Cream | PSN | 02707552-03d9-3ad2-e063-6294a90a3472 | 2 |
| 2644111 | capsaicin 0.3 MG/ML / menthol 10 MG/ML / methyl salicylate 100 MG/ML Topical Cream | SCD | 02707552-03d9-3ad2-e063-6294a90a3472 | 2 |
| 2644111 | capsaicin 0.03 % / menthol 1 % / methyl salicylate 10 % Topical Cream | SY | 02707552-03d9-3ad2-e063-6294a90a3472 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83538-101-18 | 83538010118 | 237 mL in 1 BOTTLE (83538-101-18) | 237 ml | 2023-08-08 | No | No | Current |