Biofreeze Roll-On and Overnight Roll-On
- Product NDC
- 59316-209
- 11-digit product format
- 593160209
- Labeler code
- 59316
- Product ID
- 59316-209_51e076b8-984a-b24a-e063-6294a90ae9c0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- KIT
- Labeler
- Reckitt Benckiser LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-01
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 and Overnight Roll-On
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59316-205-14 | Biofreeze Roll-On and Overnight Roll-On | 74 mL in 1 BOTTLE | GEL | 74 mL | 40 mg in 1mL | 5 |
| 59316-207-14 | Biofreeze Roll-On and Overnight Roll-On | 74 mL in 1 BOTTLE | GEL | 74 mL | 40 mg in 1mL | 5 |
| 59316-209-14 | Biofreeze Roll-On and Overnight Roll-On | 1 in 1 BOTTLE | KIT | 1 | 5 | |
| 59316-209-14 | Biofreeze Roll-On and Overnight Roll-On | 2 in 1 KIT | KIT | 2 | 5 |
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 |
|---|---|---|---|---|---|---|
| ElixirLidoFast | LIDOCAINE 5% CREAM | ELIXIR HEALTHCARE USA, LLC. | 45de5a3d-06c2-aa02-e063-6294a90a63d3 | 2025-12-13 | Warnings | M017 |
| MEDI FIRST PLUS | HYDROCORTISONE ACETATE | Orazen Inc | 5781124a-60f4-4a64-80b7-ce5f28d495b5 | 2025-12-12 | Warnings | M017 |
| MEDI-FIRST | HYDROCORTISONE ACETATE | Orazen Inc | aeffd85c-58a7-4d64-bf94-977b6fbbe713 | 2025-12-12 | Warnings | M017 |
| Joint and Muscle Relief | MENTHOL | Smart Cookie Solutions Inc. | 45c24d56-4dc9-2884-e063-6294a90a52cc | 2025-12-12 | Warnings | M017 |
| Popstar | DELAY SPRAY | Pineapple Brands LLC | 293b2da9-1261-0358-e063-6394a90aa08c | 2025-12-12 | Warnings | M017 |
| Careland Pain Relief Plus | CAMPHOR, MENTHOL, METHYL SALICYLATE | Planet (Anhui) Pharmaceutical Co., Ltd. | d9e63ddd-d003-45fa-b156-7f4452c28cbd | 2025-12-12 | Warnings | M017 |
| Glucosamine Cream EXTRA STRENGTH | HISTAMINE DIHYDROCHLORIDE | IDEAZ, LLC | f4d414b7-89e7-ad65-e053-2a95a90a25d4 | 2025-12-12 | Warnings | M017 |
| ARTHRITIS | MENTHOL | Smith Amish, LLC | 20c36972-b695-1241-e063-6394a90adf63 | 2025-12-12 | Warnings | M017 |
| FOOT | MENTHOL | Smith Amish, LLC | 20c48537-f55f-c10f-e063-6394a90a4cca | 2025-12-12 | Warnings | M017 |
| Joint Ease | MENTHOL | Smith Amish, LLC | 20c4a0f8-bdc6-d89a-e063-6294a90aa8d8 | 2025-12-12 | Warnings | M017 |
| Toast Screamin Hot | CAPSAICIN | IDEAZ, LLC | 331207e6-b8ac-b169-e063-6394a90ac169 | 2025-12-12 | Warnings | M017 |
| Pain Relief Gel-Patch | LIDOCAINE | KORVIA GLOBAL Inc. | 45ccfcae-a307-1c5f-e063-6294a90acf89 | 2025-12-12 | Warnings | M017 |
| Lidospot patch | LIDOCAINE AND MENTHOL | Fabrication Enterprises Inc | 3a6e94c4-1ca6-e77a-e063-6394a90a4bfc | 2025-12-12 | Warnings | M017 |
| LETEBEE LIGHT neuropathy pain relief cream for feet | MENTHOL | Guangdong Aimu Biological Technology Co., Ltd | 45a99afc-15ec-76c2-e063-6294a90a2220 | 2025-12-11 | Warnings | M017 |
| Cinthera | LIDOCAINE | Strand Health Group | 2746e5b2-be2d-f2d2-e063-6394a90a3690 | 2025-12-11 | Warnings | M017 |
| Equate Cool and Heat Pain Relieving Liquid | COOL AND HEAT PAIN RELIEF | Walmart, Inc. | ad156685-3bd5-6837-e053-2995a90ac788 | 2025-12-11 | Warnings | M017 |
| HUMCO Camphor Spirit | CAMPHOR 10% | Humco Holding Group, Inc. | 9a0ef0a3-3c79-41b2-8193-424a3ef9886f | 2025-12-11 | Warnings | M017 |
| T-Relief Lidocaine HCL 4% | LIDOCAINE HCL 4% | Medinatura New Mexico Inc. | 3c19aff8-fb18-78d0-e063-6294a90a9481 | 2025-12-11 | Warnings | M017 |
| Jointiva | TROLAMINE SALICYLATE 10% | Rising Pharma Holdings, Inc. | 3ee33cbf-7c0f-4982-b0b6-eeeb0202803b | 2025-12-11 | Warnings | M017 |
| LMX4 | LIDOCAINE | Ferndale Laboratories, Inc. | f0e7c92f-8b0b-4045-b659-af9f6e81260f | 2025-12-10 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1111683 | BIOFREEZE 4 % Topical Gel | PSN | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
| 415974 | menthol 4 % Topical Gel | PSN | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
| 1111683 | menthol 0.04 MG/MG Topical Gel [Biofreeze] | SBD | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
| 415974 | menthol 0.04 MG/MG Topical Gel | SCD | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
| 1111683 | Biofreeze 0.04 MG/MG Topical Gel | SY | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
| 1111683 | Biofreeze 4 % Topical Gel | SY | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
| 415974 | menthol 4 % Topical Gel | SY | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59316-205-14 | 59316020514 | 74 mL in 1 BOTTLE | 74 ml | Historical | |||
| 59316-207-14 | 59316020714 | 74 mL in 1 BOTTLE | 74 ml | Historical | |||
| 59316-209-14 | 59316020914 | 2 BOTTLE in 1 KIT (59316-209-14) / 1 KIT in 1 BOTTLE * 74 mL in 1 BOTTLE (59316-205-14) * 74 mL in 1 BOTTLE (59316-207-14) | 2 bottle | 2026-04-01 | No | No | Current |