Biofreeze Professional
- Product NDC
- 68071-4325
- 11-digit product format
- 680714325
- Labeler code
- 68071
- Product ID
- 68071-4325_1a3dd23e-1c5a-9d41-e063-6394a90a3455
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL, UNSPECIFIED FORM
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-06-03
- Substance
- MENTHOL, UNSPECIFIED FORM
- Active strength
- 50 mg/mL
- 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 |
|---|---|---|---|---|---|
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68071-4325-4 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68071-4325-4 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68071-4325-4 | 1332a3947898… | d4bfe170f9cd… |
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
- Biofreeze Professional
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL, UNSPECIFIED FORM | 50 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 66ff9726-20da-688a-e053-2a91aa0a59ac | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-06-07 | Biofreeze Professional Gel |
| 2023-01-30 | Biofreeze Professional Gel |
| 2021-02-16 | Biofreeze Professional Gel |
| 2021-01-29 | Biofreeze Professional Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-4325-4 | Biofreeze Professional | 120 mL in 1 TUBE | GEL | 120 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-4325 | BIOFREEZE PROFESSIONAL (MENTHOL, UNSPECIFIED FORM) GEL [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240608_66ff9726-20da-688a-e053-2a91aa0a59ac.zip |
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 |
|---|---|---|---|---|---|---|
| Lynx LX0864 peachy-foam antiseptic handsoap | CHLOROXYLENOL | ABC Compounding Co., Inc. | dd8025cb-d160-83a4-e053-2a95a90a51ac | 2026-05-11 | Warnings | M004 |
| Satin Foam High Foaming Antiseptic Hand Wash | CHLOROXYLENOL | Certus Medical, Inc. | ea49da65-ae5e-bfde-e053-2a95a90adef2 | 2026-05-11 | Warnings | M004 |
| Freshands Premium Foamy Antibacterial Handsoap 6876 | CHLOROXYLENOL | Consolidated Chemicals, LLC | f17299a4-28d6-e65b-e053-2a95a90a05e7 | 2026-05-11 | Warnings | M004 |
| Harris Teeter Triple Antibiotic and Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, PRAMOXINE HCL | HARRIS TEETER LLC | 4b0c0a3c-7145-97ca-e063-6394a90a1a96 | 2026-05-07 | Warnings | M004 |
| Harris Teeter Triple Antibiotic | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC | HARRIS TEETER LLC | 4e81590c-32d3-f8aa-e063-6294a90ab341 | 2026-05-06 | Warnings | M004 |
| FIRSTAR TRIPLE ANTIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Nantong Health & Beyond Hygienic Products Inc. | 5b9434ad-83d7-4df3-bfef-3db152e6c6cc | 2026-05-04 | Warnings | M004 |
| oopsie First Aid | BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE | 4 Visions LLC | 50b21f0a-1e87-51ae-e063-6294a90a8a3c | 2026-04-30 | Warnings | M004 |
| First Aid Kit, Lil Drug Store | 5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTS | Lil' Drug Store Products, Inc. | 503c6c0e-3e1a-71ed-e063-6394a90abfa2 | 2026-04-24 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | TRIFECTA PHARMACEUTICALS USA LLC | 23a35ba8-ebc6-4252-bb88-ec237425056c | 2026-04-15 | Warnings | M004 |
| El Valle Gentian Violet | GENTIAN VIOLET 1% | Pharmadel LLC | fc75aa2b-0e6e-e2f7-e053-6294a90ac01f | 2026-04-13 | Warnings | M004 |
| Bacitracin Zinc | BACITRACIN ZINC | Sun Pharmaceutical Industries, Inc. | 4afdeedf-9cdf-47d6-919f-ea907fda0290 | 2026-04-10 | Warnings | M004 |
| Family Care Triple Antibiotic Original Formula 0.33oz | TRIPLE ANTIBIOTIC ORIGINAL FORMULA | United Exchange Corp | 4f1ef127-a67e-ca60-e063-6394a90a3a3d | 2026-04-10 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | H E B | 2a143950-13b4-457e-91a4-c61a88aad84b | 2026-04-02 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | ProStat First Aid, LLC. | 4e54f479-ad87-e86b-e063-6394a90aa6d2 | 2026-03-31 | Warnings | M004 |
| El Valle Merthiolate | BENZALKONIUM CHLORIDE | Pharmadel LLC | fd7b28ca-9f71-0ff6-e053-6394a90a4822 | 2026-03-26 | Warnings | M004 |
| sojo Triple Antibiotic | TRIPLE ANTIBIOTIC | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d8429bd-24b9-ad3c-e063-6294a90aeba0 | 2026-03-21 | Warnings | M004 |
| Neosporin Plus Pain Relief Clubtray | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | f4545718-8643-a340-e053-2995a90a0079 | 2026-03-18 | Warnings | M004 |
| Bacitracin | BACITRACIN | Preferred Pharmaceuticals Inc. | 2f115e22-10f5-47fe-85df-f59e4387a373 | 2026-03-16 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | ProStat First Aid, LLC. | 4cd49c65-e347-7589-e063-6394a90a53bd | 2026-03-12 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | ProStat First Aid, LLC. | 4cc6d822-f383-2ceb-e063-6294a90aecc7 | 2026-03-11 | Warnings | M004 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1794892 | BIOFREEZE 5 % Topical Gel | PSN | 66ff9726-20da-688a-e053-2a91aa0a59ac | 6 |
| 415975 | menthol 5 % Topical Gel | PSN | 66ff9726-20da-688a-e053-2a91aa0a59ac | 6 |
| 1794892 | menthol 0.05 MG/MG Topical Gel [Biofreeze] | SBD | 66ff9726-20da-688a-e053-2a91aa0a59ac | 6 |
| 415975 | menthol 0.05 MG/MG Topical Gel | SCD | 66ff9726-20da-688a-e053-2a91aa0a59ac | 6 |
| 1794892 | Biofreeze 5 % Topical Gel | SY | 66ff9726-20da-688a-e053-2a91aa0a59ac | 6 |
| 415975 | menthol 5 % Topical Gel | SY | 66ff9726-20da-688a-e053-2a91aa0a59ac | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-4325-4 | 68071432504 | 120 mL in 1 TUBE (68071-4325-4) | 120 ml | 2018-03-09 | 0000-00-00 | No | No | Current |