Point Relief Cold Spot Pain Relieving
- Product NDC
- 51452-035
- 11-digit product format
- 514520035
- Labeler code
- 51452
- Product ID
- 51452-035_0fc4ec9e-6c21-5a8c-e063-6394a90a11ef
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Fabrication Enterprises
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-04-01
- Substance
- MENTHOL
- Active strength
- 120 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | 51452-035 | 51452-035-01 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 51452-035 | 51452-035-04 | D | Discontinued by firm | 2026-10-12 |
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 | 51452-035-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 51452-035-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 51452-035-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 51452-035-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 51452-035-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 51452-035-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 51452-035-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 51452-035-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 51452-035-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 51452-035-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 51452-035-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 51452-035-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 51452-035-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 51452-035-04 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 51452-035-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 51452-035-04 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 51452-035-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 51452-035-04 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 51452-035-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 51452-035-04 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 51452-035-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 51452-035-04 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 51452-035-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 51452-035-04 | 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
- Point Relief Cold Spot Pain Relieving
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 120 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2121666 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ad5d6f04-15e6-4548-95c2-32271c186bc1 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51452-035-01 | Point Relief Cold Spot Pain Relieving | 120 mL in 1 BOTTLE | GEL | 120 | 4 | |
| 51452-035-02 | Point Relief Cold Spot Pain Relieving | 475 mL in 1 BOTTLE | GEL | 475 | 4 | |
| 51452-035-03 | Point Relief Cold Spot Pain Relieving | 3800 mL in 1 JUG | GEL | 3800 | 4 | |
| 51452-035-04 | Point Relief Cold Spot Pain Relieving | 420 mL in 1 TUBE | GEL | 420 | 4 | |
| 51452-035-05 | Point Relief Cold Spot Pain Relieving | 950 mL in 1 BOTTLE | GEL | 950 | 4 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Non-proprietary name | HEADACHE PATCH | Nanjing 3H Medical Products Co.,Ltd. | 586d73f1-0b0b-f596-e063-6394a90a4d57 | 2026-08-06 | Warnings | M017 |
| Point Relief Coldspot Pain Relieving | MENTHOL | Fabrication Enterprises Inc | 479fb728-4aeb-42e3-b238-f04255514baa | 2026-08-05 | Warnings | M017 |
| Dealmed Burn | LIDOCAINE | Dealmed Medical Supplies, LLC. | 3b5f7ded-c275-4d7f-9fd4-539797d5507e | 2026-08-05 | Warnings | M017 |
| Lidocaine HCl | LIDOCAINE HCL | Topco Associates LLC | 584e1f35-4d99-9c85-e063-6294a90ab3d0 | 2026-08-05 | Warnings, Adverse reactions | M017 |
| Hempe HOT Muscle and Joint Gel | HEMPE | Healthcare International Research Limited | 5854a80e-c92b-3ff5-e063-6294a90a2d05 | 2026-08-05 | Warnings | M017 |
| Lidocaine Plantar Relief Roll-On | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 585ccb4b-3bff-39b9-e063-6294a90a0e18 | 2026-08-05 | Warnings | M017 |
| Green MARVEL PAIN RELIEF | MENTHOL, CAMPHOR, METHYL SALICYLATE | Miramar Cosmetics, Inc DBA Miramar Lab | 9ff6e477-ef79-4a0c-9e21-8cae0e5d8810 | 2026-08-05 | Warnings | M017 |
| tuiwaro LIDOCAINE Cream | LIDOCAINE CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 56e36592-a935-61d4-e063-6294a90a6e4c | 2026-08-04 | Warnings | M017 |
| Mineral Ice Extreme Menthol Pain Relief | MENTHOL | Carlin Consumer Health LLC | 584f5c6e-3385-3221-e063-6294a90aabae | 2026-08-04 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 484fe5e4-a058-49c0-a382-c8fc3e20c3b2 | 2026-08-04 | Warnings | M017 |
| procure | HYDROCORTISONE ACETATE | TWIN MED, LLC | 2670c9c4-66ad-40e8-a08a-582b160de39d | 2026-08-03 | Warnings | M017 |
| Wini By Locsanity Advanced Formula Muscle Joint Relief Balm | METHYL SALICYLATE,CAMPHOR,MENTHOL | Locsanity LLC | 5829b5d7-78d4-78a2-e063-6394a90a3dfc | 2026-08-03 | Warnings | M017 |
| Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On | MENTHOL | Chattem, Inc. | aa40c907-eeb5-4fda-b35e-439cbecc178c | 2026-07-31 | Warnings | M017 |
| Alphamale Delay Cream | BENZOCAINE | Prodigy Media Inc | 53d682ee-0802-a16d-e063-6394a90aeee1 | 2026-07-31 | Warnings | M017 |
| Pure Primal Delay Cream | BENZOCAINE | Prodigy Media Inc | 57e9e894-c14f-d806-e063-6394a90ab8e5 | 2026-07-31 | Warnings | M017 |
| Satohap | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Sato Pharmaceutical Co., Ltd. | df0e2b83-8f61-4ed8-bcc4-55e4ea782090 | 2026-07-31 | Warnings | M017 |
| Satogesic | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Sato Pharmaceutical Co., Ltd. | cb000134-92a4-4304-8ef0-0347190e1414 | 2026-07-31 | Warnings | M017 |
| Satogesic Hot | CAPSAICIN | Sato Pharmaceutical Co., Ltd. | 16b47cb5-ea5f-4514-9a89-141ee4cc60f8 | 2026-07-31 | Warnings | M017 |
| Satohap Cool and Hot Pads | CAMPHOR, CAPSAICIN, MENTHOL | Sato Pharmaceutical Co., Ltd. | b6bf1eab-4ab9-f500-e053-2995a90a8d7b | 2026-07-31 | Warnings, Adverse reactions | M017 |
| SATOHAP COOL and HOT | CAMPHOR, CAPSAICIN, MENTHOL | Sato Pharmaceuticals Co., Ltd. | 232a4c76-1a0c-2f4b-e063-6394a90a8849 | 2026-07-31 | Warnings, Adverse reactions | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2121666 | menthol 0.12 MG/MG Topical Gel | PSN | ad5d6f04-15e6-4548-95c2-32271c186bc1 | 4 |
| 2121666 | menthol 0.12 MG/MG Topical Gel | SCD | ad5d6f04-15e6-4548-95c2-32271c186bc1 | 4 |
| 2121666 | menthol 12 % Topical Gel | SY | ad5d6f04-15e6-4548-95c2-32271c186bc1 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51452-035-01 | 51452003501 | 120 mL in 1 BOTTLE (51452-035-01) | 120 ml | 2019-04-01 | 0000-00-00 | No | No | Current |
| 51452-035-02 | 51452003502 | 475 mL in 1 BOTTLE (51452-035-02) | 475 ml | 2019-04-01 | 0000-00-00 | No | No | Current |
| 51452-035-03 | 51452003503 | 3800 mL in 1 JUG (51452-035-03) | 3800 ml | 2019-04-01 | 0000-00-00 | No | No | Current |
| 51452-035-04 | 51452003504 | 420 mL in 1 TUBE (51452-035-04) | 420 ml | 2019-04-01 | 0000-00-00 | No | No | Current |
| 51452-035-05 | 51452003505 | 950 mL in 1 BOTTLE (51452-035-05) | 950 ml | 2019-04-01 | 0000-00-00 | No | No | Current |