Biofreeze Roll-On
- Product NDC
- 50090-6358
- 11-digit product format
- 500906358
- Labeler code
- 50090
- Product ID
- 50090-6358_1e426c73-8145-47fe-9470-39c853f54446
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- A-S Medication Solutions
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-01-17
- Substance
- MENTHOL
- Active strength
- 40 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 Roll-On
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 814b37ea-5441-4cec-8794-71ca01d849ae | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-6358-0 | Biofreeze Roll-On | 74 mL in 1 BOTTLE | GEL | 74 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-6358-0 | ML - Milliliter | 50090-6358 | 8768d2b3-9bd6-46d0-8426-3ac6ed8020de | 1 | 2023-03-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-6358 | BIOFREEZE ROLL-ON (MENTHOL) GEL [A-S MEDICATION SOLUTIONS] | 3 | Current NDC, 1 package rows | 20231102_814b37ea-5441-4cec-8794-71ca01d849ae.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 |
|---|---|---|---|---|---|---|
| Blue-Emu THRIVE Cooling | TRIPELENNAMINE 0.5% | Kingsway Pharmaceuticals dba NFI, LLC | 7ac6456a-42c5-4ac8-aae6-db4abfda9df0 | 2025-12-22 | Warnings | M017 |
| MENTHOL | MENTHOL | SUNSET PAIN RELIEF | 45c5ca6f-d425-6cfb-e063-6394a90a1b66 | 2025-12-20 | Warnings | M017 |
| HERSTAT GST Genital Sore Treatment | CAMPHOR, MENTHOL | Herstat (USA) Inc. | e8d27684-fb15-2e6a-e053-2a95a90a248f | 2025-12-19 | Warnings | M017 |
| Kroger Anti Itch | HYDROCORTISONE | The Kroger Co | 46547277-f11a-b9e7-e063-6294a90a2ccd | 2025-12-19 | Warnings | M017 |
| Kroger Cool and Heat Roll-On | MENTHOL | Kroger | 46551d07-3006-c3ec-e063-6294a90aa3f2 | 2025-12-19 | Warnings | M017 |
| Naughty Kitty Kat | NO GAG DEEP THROAT SPRAY | INKED SUGAR, INC | 170eb644-c72c-5744-e063-6394a90a767d | 2025-12-19 | Warnings | M017 |
| Tiger Balm Red Extra Strength | CAMPHOR (SYNTHETIC) AND MENTHOL | Haw Par Healthcare Ltd. | ce703715-4c11-472c-9270-daac87b7be05 | 2025-12-19 | Warnings | M017 |
| Aspercreme with Lidocaine Foot Pain Creme | LIDOCAINE HYDROCHLORIDE | Chattem, Inc. | da82cc0e-cc39-408e-87e1-c35bb6f9f51e | 2025-12-19 | Warnings | M017 |
| Health Trak Plus Menthol-Infused Pain Relief Socks | MENTHOL | Railroad Sock LLC | 43413e55-1db2-fc1a-e063-6394a90a7167 | 2025-12-18 | Warnings | M017 |
| BIO-ICE | MENTHOL, CAMPHOR | Electrostim Medical Services Inc. d/b/a EMSI | 1bfd1468-9139-43b1-9709-d47b63d17cfb | 2025-12-18 | Warnings | M017 |
| Lidotrode | LIDOCAINE | Strand Health Group | 1fd20b9a-b8bc-c94f-e063-6394a90a2b69 | 2025-12-18 | Warnings | M017 |
| A Health Itch Relief Gel | ITCH RELIEF GEL | Bionpharma, Inc. | ecf5decb-c98b-7739-e053-2995a90a5541 | 2025-12-18 | Warnings | M017 |
| After Burn | 2.5% LIDOCAINE HCL | Tender Corporation d/b/a Adventure Ready Brands | 4640395f-a76c-d022-e063-6294a90adde6 | 2025-12-18 | Warnings | M017 |
| SPARTAN WIPES | ENDURANCE WIPES | TIV PRIME SRL | 26d02431-2c95-001c-e063-6394a90a29c7 | 2025-12-18 | Warnings | M017 |
| Stopain Extra Strength Continuous | MENTHOL | Troy Manufacturing, Inc. | a0f76968-d22c-4b1c-a9e6-8d0179a2e98e | 2025-12-18 | Warnings | M017 |
| ZIMS MAX FREEZE | LIDOCAINE HYDROCHLORIDE AND MENTHOL, | KOBAYASHI Healthcare International, Inc. | e364ff83-4aaf-4897-a7da-06581bc321f2 | 2025-12-18 | Warnings | M017 |
| Tiger Balm White Regular Strength | CAMPHOR (SYNTHETIC) AND MENTHOL | Haw Par Healthcare Ltd. | f406161e-a9c4-47d1-8b21-93b1b7938063 | 2025-12-17 | Warnings | M017 |
| Resinol | PETROLATUM AND RESORCINOL | ResiCal, Inc. | 03f57a4a-f94b-4ba6-b709-41cfb6e16261 | 2025-12-17 | Warnings | M017 |
| HealthWise Maximum Pain Relief | LIDOCAINE | Veridian Healthcare | afc3c16d-0076-44b2-ae7e-5f36d4d8088e | 2025-12-17 | Warnings | M017 |
| HealthWise Max Lidocaine plus Menthol | LIDOCAINE, MENTHOL | Veridian Healthcare | f39a27da-6799-4fc6-97ca-101eac4a9360 | 2025-12-17 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1111683 | BIOFREEZE 4 % Topical Gel | PSN | 814b37ea-5441-4cec-8794-71ca01d849ae | 3 |
| 415974 | menthol 4 % Topical Gel | PSN | 814b37ea-5441-4cec-8794-71ca01d849ae | 3 |
| 1111683 | menthol 0.04 MG/MG Topical Gel [Biofreeze] | SBD | 814b37ea-5441-4cec-8794-71ca01d849ae | 3 |
| 415974 | menthol 0.04 MG/MG Topical Gel | SCD | 814b37ea-5441-4cec-8794-71ca01d849ae | 3 |
| 1111683 | Biofreeze 0.04 MG/MG Topical Gel | SY | 814b37ea-5441-4cec-8794-71ca01d849ae | 3 |
| 1111683 | Biofreeze 4 % Topical Gel | SY | 814b37ea-5441-4cec-8794-71ca01d849ae | 3 |
| 415974 | menthol 4 % Topical Gel | SY | 814b37ea-5441-4cec-8794-71ca01d849ae | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-6358-0 | 50090635800 | 74 mL in 1 BOTTLE (50090-6358-0) | 74 ml | 2023-02-07 | No | No | Current |