Biofreeze Professional
- Product NDC
- 50090-6367
- 11-digit product format
- 500906367
- Labeler code
- 50090
- Product ID
- 50090-6367_e2597670-90c0-42b1-a9be-97f043fcecff
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL, UNSPECIFIED FORM
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- A-S Medication Solutions
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-06-03
- Substance
- MENTHOL
- Active strength
- 50 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | 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 |
|---|---|
| cbeac814-59d8-4c13-8e73-bca66f797f8d | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-6367-0 | Biofreeze Professional | 118 mL in 1 TUBE | GEL | 118 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-6367-0 | ML - Milliliter | 50090-6367 | f4d9274b-5961-4844-9e84-5d72cdf7b023 | 1 | 2023-03-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-6367 | BIOFREEZE PROFESSIONAL (MENTHOL, UNSPECIFIED FORM) GEL [A-S MEDICATION SOLUTIONS] | 3 | Current NDC, 1 package rows | 20250112_cbeac814-59d8-4c13-8e73-bca66f797f8d.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 |
|---|---|---|---|---|---|---|
| PAINGEL UNGUENTO | CAMPHOR, MENTHOL | NACOR BUSINESS GROUP LLC | 42fab525-b0a5-97fb-e063-6394a90aec6c | 2025-11-06 | Warnings | M017 |
| PAINGEL ROLL-ON | MENTHOL | NACOR BUSINESS GROUP LLC | 42fb0bdf-8bbd-bbe3-e063-6294a90a656c | 2025-11-06 | Warnings | M017 |
| Coolexa | CAMPHOR, MENTHOL, METHYL SALICYLATE | Rising Pharma Holdings, Inc. | 38839f29-d4ce-4684-a3c7-0bb4bf1ad594 | 2025-11-06 | Warnings | M017 |
| ItchZap | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Rising Pharma Holdings, Inc. | 245d0afb-19a8-4cfb-968b-d892b18d5f2c | 2025-11-06 | Warnings | M017 |
| Pain Relief Gel-Roll On | LIDOCAINE AND MENTHOL | Bullet point LLC | 42c70681-494b-47c9-e063-6394a90a80be | 2025-11-04 | Warnings | M017 |
| China-Gel Topical Pain Reliever | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, LLC | ba6c7e97-d740-484b-8711-55fa7ab15784 | 2025-11-04 | Warnings | M017 |
| China-Gel | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, Inc. | d7c5cb17-f7a2-7f57-e053-2995a90a40f7 | 2025-11-04 | Warnings | M017 |
| Aulief Topical Pain Reliever | MENTHOL AND CAMOHOR | China-Gel, LLC | 8647dcc3-1dbc-1093-e053-2991aa0a1ab9 | 2025-11-04 | Warnings | M017 |
| China-Gel Topical Pain Reliever | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, LLC | 254abae9-ef1b-5a90-e054-00144ff88e88 | 2025-11-04 | Warnings | M017 |
| Pain Relief Gel-Tube | MENTHOL | Bullet point LLC | 42c93789-9758-54b7-e063-6394a90ac398 | 2025-11-04 | Warnings | M017 |
| Tattoo care | TATTOO CARE CREAM | Perfso (HK) Co., Limited | 42d0f56f-9cb1-8e19-e063-6394a90aa3e0 | 2025-11-04 | Warnings | M017 |
| CORE RELIEF | CAMPHOR, MENTHOL | Copper Joint, LLC | 42d17270-f58d-9d69-e063-6294a90a4078 | 2025-11-04 | Warnings | M017 |
| Lidocaine and Menthol | LIDOCAINE AND MENTHOL | Marcella Health | d25f25ee-79f8-49e7-9715-0aae305b73e5 | 2025-11-03 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS NO TOUCH SPRAY | Premier Brands of America Inc. | 36481d67-2346-470b-e063-6294a90aae99 | 2025-11-03 | Warnings | M017 |
| Lidocaine Numbing Cream | LIDOCAINE 5% | YYBA Corp | 1319ee69-8b3f-5815-e063-6294a90a5ad5 | 2025-11-03 | Warnings | M017 |
| Goodsense Extra Strength Cold and Hot Medicated | MENTHOL | Geiss, Destin and Dunn, Inc. | 7585d111-775f-4fb6-a485-28cd99d88852 | 2025-10-31 | Warnings | M017 |
| Topcare Cold and Hot Medicated | MENTHOL | Topco Associates LLC | 8739aedd-165c-5ae0-e053-2a91aa0afcd0 | 2025-10-31 | Warnings | M017 |
| CVS Medicated Heat 1 ct | CAPSAICIN | CVS Pharmacy, Inc. | d41dce5b-e698-4930-8869-040b2a973f25 | 2025-10-31 | Warnings | M017 |
| Coralite Medicated Heat | CAPSAICIN | United Exchange Corp. | a0b89c7e-80bc-43c4-840c-5fd567f60b21 | 2025-10-31 | Warnings | M017 |
| Dragon with Arnical Pain Relief | MENTHOL | Genomma Lab USA Inc. | b4cbb7b6-cb71-9721-e053-2995a90a2b2c | 2025-10-31 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1794892 | BIOFREEZE 5 % Topical Gel | PSN | cbeac814-59d8-4c13-8e73-bca66f797f8d | 3 |
| 415975 | menthol 5 % Topical Gel | PSN | cbeac814-59d8-4c13-8e73-bca66f797f8d | 3 |
| 1794892 | menthol 0.05 MG/MG Topical Gel [Biofreeze] | SBD | cbeac814-59d8-4c13-8e73-bca66f797f8d | 3 |
| 415975 | menthol 0.05 MG/MG Topical Gel | SCD | cbeac814-59d8-4c13-8e73-bca66f797f8d | 3 |
| 1794892 | Biofreeze 5 % Topical Gel | SY | cbeac814-59d8-4c13-8e73-bca66f797f8d | 3 |
| 415975 | menthol 5 % Topical Gel | SY | cbeac814-59d8-4c13-8e73-bca66f797f8d | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-6367-0 | 50090636700 | 118 mL in 1 TUBE (50090-6367-0) | 118 ml | 2023-02-09 | No | No | Current |