BIOFREEZE
- Product NDC
- 59316-102
- 11-digit product format
- 593160102
- Labeler code
- 59316
- Product ID
- 59316-102_51b44481-a7ad-8a46-e063-6294a90aefda
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-01-03
- Substance
- MENTHOL, UNSPECIFIED FORM
- Active strength
- 40 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 59316-102 | 59316-102-15 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 59316-102 | 59316-102-16 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 59316-102 | 59316-102-25 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 59316-102 | 59316-102-91 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 59316-102 | 59316-102-92 | D | Discontinued by firm | 2026-10-15 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59316-102-25 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59316-102-16 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59316-102-15 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59316-102-25 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59316-102-16 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59316-102-15 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59316-102-25 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59316-102-16 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59316-102-15 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59316-102-25 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59316-102-16 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59316-102-15 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59316-102-25 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59316-102-16 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59316-102-15 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59316-102-25 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59316-102-16 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59316-102-15 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59316-102-25 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59316-102-16 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59316-102-15 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59316-102-25 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59316-102-16 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59316-102-15 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59316-102-25 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59316-102-16 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59316-102-15 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59316-102-25 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59316-102-16 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59316-102-15 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59316-102-25 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59316-102-16 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59316-102-15 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59316-102-25 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59316-102-16 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59316-102-15 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL, UNSPECIFIED FORM | 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 |
|---|---|
| 83d5c2f2-2413-4d28-83b2-0808d0917b4d | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59316-102-10 | BIOFREEZE | 5 mL in 1 BOTTLE | GEL | 5 | 35 | |
| 59316-102-11 | BIOFREEZE | 3 mL in 1 BOTTLE | GEL | 3 | 35 | |
| 59316-102-12 | BIOFREEZE | 89 mL in 1 BOTTLE | GEL | 89 | 35 | |
| 59316-102-15 | BIOFREEZE | 89 mL in 1 BOTTLE, WITH APPLICATOR | GEL | 89 | 35 | |
| 59316-102-16 | BIOFREEZE | 89 mL in 1 BOTTLE, WITH APPLICATOR | GEL | 89 | 35 | |
| 59316-102-20 | BIOFREEZE | 118 mL in 1 BOTTLE | GEL | 118 | 35 | |
| 59316-102-25 | BIOFREEZE | 118 mL in 1 BOTTLE, WITH APPLICATOR | GEL | 118 | 35 | |
| 59316-102-28 | BIOFREEZE | 237 mL in 1 BOTTLE | GEL | 237 | 35 | |
| 59316-102-30 | BIOFREEZE | 473 mL in 1 BOTTLE | GEL | 473 | 35 | |
| 59316-102-40 | BIOFREEZE | 946 mL in 1 BOTTLE | GEL | 946 | 35 | |
| 59316-102-50 | BIOFREEZE | 3785 mL in 1 CONTAINER | GEL | 3785 | 35 | |
| 59316-102-80 | BIOFREEZE | 44 mL in 1 TUBE | GEL | 44 | 35 | |
| 59316-102-90 | BIOFREEZE | 100 in 1 CARTON | GEL | 100 | 35 | |
| 59316-102-91 | BIOFREEZE | 10 in 1 CARTON | GEL | 10 | 35 | |
| 59316-102-92 | BIOFREEZE | 16 in 1 CARTON | GEL | 16 | 35 | |
| 59316-102-98 | BIOFREEZE | 30 mL in 1 BOTTLE | GEL | 30 | 35 | |
| 59316-102-80 | Biofreeze | 44 mL in 1 TUBE | GEL | 44 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59316-102-12 | ML - Milliliter | 59316-102 | 8c11b8a5-4f02-41bf-88b6-e4af8c4214f8 | 1 | 2018-09-05 |
| 59316-102-20 | ML - Milliliter | 59316-102 | 63342204-7fd4-4732-9ec3-4df580a6e6ce | 1 | 2015-06-09 |
| 59316-102-28 | ML - Milliliter | 59316-102 | e8471990-bf89-42b8-8a43-721055ce7645 | 1 | 2018-09-05 |
| 59316-102-30 | ML - Milliliter | 59316-102 | 8537e275-8662-4f2c-ae52-44981681af99 | 1 | 2024-08-12 |
| 59316-102-40 | ML - Milliliter | 59316-102 | 030b1aca-eae8-43da-9839-6522c8c985ac | 1 | 2024-08-12 |
| 59316-102-50 | ML - Milliliter | 59316-102 | 35b2fa59-5fb2-4779-a89d-b84cda167825 | 1 | 2024-08-12 |
| 59316-102-80 | ML - Milliliter | 59316-102 | 39ef3edc-90e7-4701-bbcc-add710ddea6d | 1 | 2024-08-12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59316-102 | BIOFREEZE (MENTHOL) GEL [RB HEALTH (US) LLC] | 34 | Current NDC, Legacy NDC, 16 package rows | 20231114_83d5c2f2-2413-4d28-83b2-0808d0917b4d.zip |
| 59316-102 | BIOFREEZE (MENTHOL) GEL [PERFORMANCE HEALTH, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20181108_f0c4d165-a242-4fb5-b2de-d64a825a29e9.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 |
|---|---|---|---|---|---|---|
| REINREUDE BACK PAIN THERAPY | CAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPY | Jiangxi Yudexi Pharmaceutical Co., LTD | 4dfc77bb-11dd-e0f0-e063-6294a90a4e9c | 2026-07-24 | Warnings | M017 |
| DRAVYNOR QUIT SMOKING Patches | NICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHES | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5768631f-d517-5b43-e063-6294a90a8f46 | 2026-07-24 | Warnings | M017 |
| DERMFREE NUMBING | LIDOCAINE4% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5b47ce-2bf1-42c7-e063-6294a90af09f | 2026-07-23 | Warnings | M017 |
| DERMFREE WART CORN REMOVER | SALICYLIC ACID 40% WART CORN REMOVER | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5c63b3-44de-8736-e063-6394a90ac21a | 2026-07-23 | Warnings | M017 |
| DERMFREE Anti-itch | HYDROCORTISONE1% ANTI-ITCH | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5af4c6-555a-e74c-e063-6394a90aa6ce | 2026-07-23 | Warnings | M017 |
| DERMFREE HEMORRHOID | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5d0e79-d620-0147-e063-6294a90a3103 | 2026-07-23 | Warnings | M017 |
| MAG 5 PT WARMING FORMULA | MENTHOL | RENU LABORATORIES, LLC | a499ac9b-0e8e-e23f-e053-2a95a90abe9a | 2026-07-23 | Warnings | M017 |
| Icy Hot Performance Cream Pain Relief | MENTHOL 16%, CAMPHOR 11% | Chattem, Inc. | 73f7a113-ef11-4932-bf4d-4e62863f7941 | 2026-07-23 | Warnings | M017 |
| Numbing Pain Relief | LIDOCAINE 4% | Walgreen Company | 2425badb-e196-e9f8-e063-6294a90a7bf4 | 2026-07-22 | Warnings | M017 |
| Cooling Pain Relief | MENTHOL 4.5% | Walgreen Company | 24345ccf-c96f-31b0-e063-6294a90a82b5 | 2026-07-22 | Warnings | M017 |
| Heat Pain Relief | CAPSAICIN 0.1% | Walgreen Company | 2434f9cf-74aa-17af-e063-6294a90a56d9 | 2026-07-22 | Warnings | M017 |
| Pain Relief Patch Lidocaine | LIDOCAINE | HyVee | 41c26a66-3371-2c2c-e063-6294a90aa38b | 2026-07-22 | Warnings | M017 |
| CVS Ultra Strength Muscle | MENTHOL, CAMPHOR, METHYL SALICYLATE | CVS Pharmacy | 48bef8bc-6e39-a328-e063-6394a90ae450 | 2026-07-22 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | AKRON PHARMA INC | daad9a1e-98d2-4ce7-9d97-ac5d81905abb | 2026-07-22 | Warnings | M017 |
| Professional Therapy MuscleCare Pain Relieving | MENTHOL, CAMPHOR | Active and Innovative | 573c2d85-9e0b-7955-e063-6394a90aff64 | 2026-07-22 | Warnings | M017 |
| DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF | BENZALKONIUM CHLORIDE, LIDOCAINE | Enviro Specialty Chemicals Inc | f7abe66c-dc2d-4ef7-9b11-5b87157fd302 | 2026-07-21 | Warnings | M017 |
| Bclsks NUMBING | MENTHOL 1% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 49e26770-ddf6-7515-e063-6394a90a4ab3 | 2026-07-21 | Warnings | M017 |
| Rstrvbr QUIT SMOKING | NICOTINE21MG QUIT SMOKING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5e9691-727f-6bcd-e063-6294a90aadfc | 2026-07-21 | Warnings | M017 |
| Rstrvbr QUIT SMOKING | NICOTINE14MG QUIT SMOKING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5eec19-7f9a-d277-e063-6294a90ace95 | 2026-07-21 | Warnings | M017 |
| Rstrvbr QUIT SMOKING | NICOTINE7MG QUIT SMOKING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5f124e-2dd7-16b8-e063-6294a90a5cdb | 2026-07-21 | Warnings | M017 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59316-102-10 | 59316010210 | 5 mL in 1 BOTTLE (59316-102-10) | 5 ml | 2012-01-03 | 0000-00-00 | No | No | Current |
| 59316-102-11 | 59316010211 | 3 mL in 1 BOTTLE (59316-102-11) | 3 ml | 2012-01-03 | 0000-00-00 | No | No | Current |
| 59316-102-12 | 59316010212 | 89 mL in 1 BOTTLE (59316-102-12) | 89 ml | 2016-09-19 | 0000-00-00 | No | No | Current |
| 59316-102-15 | 59316010215 | 89 mL in 1 BOTTLE, WITH APPLICATOR | 89 ml | Historical | ||||
| 59316-102-16 | 59316010216 | 89 mL in 1 BOTTLE, WITH APPLICATOR | 89 ml | Historical | ||||
| 59316-102-20 | 59316010220 | 118 mL in 1 BOTTLE (59316-102-20) | 118 ml | 2012-01-03 | 0000-00-00 | No | No | Current |
| 59316-102-25 | 59316010225 | 118 mL in 1 BOTTLE, WITH APPLICATOR (59316-102-25) | 118 ml | 2012-01-03 | 2021-12-31 | No | No | Current |
| 59316-102-28 | 59316010228 | 237 mL in 1 BOTTLE (59316-102-28) | 237 ml | 2016-09-19 | 0000-00-00 | No | No | Current |
| 59316-102-30 | 59316010230 | 473 mL in 1 BOTTLE (59316-102-30) | 473 ml | 2012-01-03 | 0000-00-00 | No | No | Current |
| 59316-102-40 | 59316010240 | 946 mL in 1 BOTTLE (59316-102-40) | 946 ml | 2012-01-03 | 0000-00-00 | No | No | Current |
| 59316-102-50 | 59316010250 | 3785 mL in 1 CONTAINER (59316-102-50) | 3785 ml | 2012-01-03 | 0000-00-00 | No | No | Current |
| 59316-102-80 | 59316010280 | 44 mL in 1 TUBE (59316-102-80) | 44 ml | 2018-11-02 | 0000-00-00 | No | No | Current |
| 59316-102-90 | 59316010290 | 100 BOTTLE in 1 CARTON (59316-102-90) / 5 mL in 1 BOTTLE (59316-102-10) | 100 bottle | 2012-01-03 | 0000-00-00 | No | No | Current |
| 59316-102-91 | 59316010291 | 10 BOTTLE in 1 CARTON (59316-102-91) > 3 mL in 1 BOTTLE (59316-102-11) | 10 bottle | 2012-01-03 | 0000-00-00 | No | No | Current |
| 59316-102-92 | 59316010292 | 16 BOTTLE in 1 CARTON (59316-102-92) > 3 mL in 1 BOTTLE (59316-102-11) | 16 bottle | 2012-01-03 | 0000-00-00 | No | No | Current |
| 59316-102-98 | 59316010298 | 30 mL in 1 BOTTLE (59316-102-98) | 30 ml | 2012-01-03 | 0000-00-00 | No | No | Current |