BIO-ICE
- Product NDC
- 50130-316
- 11-digit product format
- 501300316
- Labeler code
- 50130
- Product ID
- 50130-316_463d9205-8ccc-8c5c-e063-6394a90a47c5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL, CAMPHOR
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Electrostim Medical Services Inc. d/b/a EMSI
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-01-01
- Substance
- MENTHOL; CAMPHOR (SYNTHETIC)
- Active strength
- 5.4; .48 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 |
|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 50130-316-11 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 50130-316-11 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 50130-316-11 | bd6a592717d7… | 303034d00443… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 50130-316-11 | e2bbac7714bc… | 27bdfed8d636… |
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
- BIO-ICE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 5.4 g/100mL |
| CAMPHOR (SYNTHETIC) | .48 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
| 5TJD82A1ET | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1372902 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1bfd1468-9139-43b1-9709-d47b63d17cfb | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50130-316-11 | BIO-ICE | 88.8 mL in 1 BOTTLE | GEL | 88.8 | 8 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| OKeeffes Working Hands Pain Relief Skin Protectant | ALLANTOIN, LIDOCAINE HYDROCHLORIDE | The Gorilla Glue Company/O'Keeffe's Company | 0685da25-c9fa-e1cd-e063-6394a90ae1b3 | 2025-01-01 | Warnings | M017 |
| Icy Hot with Lidocaine Pain Relieving | LIDOCAINE HCL AND MENTHOL | Chattem, Inc. | 75b28b06-77ea-4fea-b516-2e8a0dac7037 | 2025-01-01 | Warnings | M017 |
| Advanced Seal Barrier plus Pain Relief | LIDOCAINE | Kericure Inc. | 7ac95325-e6e9-4c56-9315-876c00af7c98 | 2025-01-01 | Warnings | M017 |
| FixMySkin Healing Balm Fragrance-Free | HYDROCORTISONE | Lovely Skin, Inc. | c12af4c6-2f05-46ec-b901-1a4fcd750180 | 2024-12-31 | Warnings | M017 |
| Pain Relieving Cream Lidocaine | BENZYL ALCOHOL, LIDOCAINE HCI | Trifecta Pharmaceuticals USA LLC | 039a2036-54b2-cf28-e063-6294a90a8ce6 | 2024-12-31 | Warnings | M017 |
| Cold Therapy Pain Relief Walgreens | MENTHOL 10.5% | WALGREEN COMPANY | f1daa68d-1b12-c28a-e053-2995a90a0949 | 2024-12-31 | Warnings | M017 |
| Calypxo Pain Relief | METHYL SALICYLATE, MENTHOL | Advanced Rx of Tennessee, LLC | 0b7736df-c7e0-7d00-e063-6294a90aa57e | 2024-12-31 | Warnings | M017 |
| New Terocin | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | Advanced Rx Pharmacy of Tennessee, LLC | f4bfc4a6-06ef-1f76-e053-2995a90a2b8f | 2024-12-31 | Warnings | M017 |
| Lidocaine | LIDOCAINE | Advanced Rx Pharmacy of Tennessee, LLC | 01cb19a4-ce22-144d-e063-6294a90a8aa3 | 2024-12-31 | Warnings | M017 |
| Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream | LIDOCAINE, MENTHOL | Sato Pharmaceutical Co., Ltd. | 2251e96b-d050-4ec2-a6b9-6659610885bf | 2024-12-30 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Safeway | af2e2ef3-0f3f-4592-8081-b6553ade2f5a | 2024-12-26 | Warnings | M017 |
| Comforte Menstrual Cramp Relief Cream | MENTHOL | PMS4PMS LLC | c121537e-3333-4f35-8c77-20086158dff4 | 2024-12-26 | Warnings | M017 |
| N-Labs Arcticzen Pain Relief Knee | CAMPHOR (SYNTHETIC), MENTHOL | NUTRIOMO LABS PTE. LTD | 05ee574a-854c-4a77-be77-082055075c4d | 2024-12-26 | Warnings | M017 |
| BiteMD External Analgesic First Aid Antiseptic | BENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOL | United Industries Corporation | 4c60db03-6d2b-4ae0-a200-718b3a50eb0f | 2024-12-23 | Warnings | M017 |
| GNP Anti Itch | CAMPHOR, MENTHOL | AMERISOURCEBERGEN DRUG CORPORATION | b4f2d6f7-2287-47d8-e053-2995a90ae335 | 2024-12-23 | Warnings | M017 |
| cool and heat pain relieving liquid | MENTHOL | Bionpharma Inc. | ec6f59d8-45c5-46a0-e053-2995a90a239f | 2024-12-23 | Warnings | M017 |
| FOOT WORKS MAXIMUM CRACKED HEEL | BENZALKONIUM CHLORIDE, LIDOCAINE | COSMAX USA, CORPORATION | 29f92230-d1d4-5e94-e063-6294a90af812 | 2024-12-23 | Warnings | M017 |
| pain relief roll-on | LIDOCAINE 4% | Bionpharma Inc. | f607b6dc-8d13-604a-e053-2995a90a59ab | 2024-12-23 | Warnings | M017 |
| Veneno de Abeja Aceite De Vibora Brand | METHYL SALICYLATE | Miramar Cosmetics, Inc DBA Miramar Lab | a6c4889c-e7a9-44b9-bd9a-70fd6e8c4825 | 2024-12-23 | Warnings | M017 |
| Itch Relief | HYDROCORTISONE 1% | Trifecta Pharmaceuticals USA LLC | af5daf6c-bcad-8ebf-e053-2a95a90af1b0 | 2024-12-20 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1372902 | camphor 0.48 % / menthol 5.4 % Topical Gel | PSN | 1bfd1468-9139-43b1-9709-d47b63d17cfb | 8 |
| 1372902 | camphor 0.0048 MG/MG / menthol 0.054 MG/MG Topical Gel | SCD | 1bfd1468-9139-43b1-9709-d47b63d17cfb | 8 |
| 1372902 | camphor 0.48 % / menthol 5.4 % Topical Gel | SY | 1bfd1468-9139-43b1-9709-d47b63d17cfb | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50130-316-11 | 50130031611 | 88.8 mL in 1 BOTTLE (50130-316-11) | 88.8 ml | 2013-01-01 | 0000-00-00 | No | No | Current |