Pain Relieving Roll-On
- Product NDC
- 68678-040
- 11-digit product format
- 686780040
- Labeler code
- 68678
- Product ID
- 68678-040_3dd5fc5a-32c4-78bf-e063-6394a90af02a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol, Camphor, Capsaicin
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- AHC VENTURES CORP DBA CRY
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-01-01
- Substance
- MENTHOL; CAMPHOR (SYNTHETIC); CAPSAICIN
- Active strength
- 3.85; 3.85; .0355 g/100mL; g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 68678-040-90 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 68678-040-90 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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
- Pain Relieving Roll-On
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 3.85 g/100mL |
| CAMPHOR (SYNTHETIC) | 3.85 g/100mL |
| CAPSAICIN | .0355 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
| 5TJD82A1ET | Internal UNII lookup |
| S07O44R1ZM | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 799751f3-726a-42de-934e-dbc3cd1cb8b8 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-09-02 | Cryoderm Heat Warming Roll On |
| 2024-01-30 | Cryoderm Heat Warming Roll On |
| 2022-04-21 | Cryoderm Heat Warming Roll On |
| 2020-01-31 | Cryoderm Heat Warming Roll On |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68678-040-90 | Pain Relieving Roll-On | 84 mL in 1 BOTTLE, DISPENSING | LOTION | 84 | 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 |
|---|---|---|---|---|---|---|
| RELIBONEOintment | TOPICAL ANALGESICOINTMENT | Guangdong Jiaoyu Biotechnology Co., Ltd | 58ddaaf6-18ec-8c5b-e063-6294a90a2828 | 2026-08-12 | Warnings | M017 |
| Capsaicin Cream | CAPSAICIN | Trifecta Pharmaceuticals USA LLC | 58de3a29-2bec-6e44-e063-6394a90a9c1a | 2026-08-12 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | Amazon.com Services LLC | f40b4223-e81f-4cd0-bc9b-d3d33ce8cce5 | 2026-08-12 | Warnings | M017 |
| Muscle Rub Cream | MUSCLE RUB | ALLIED TRADE LINK LLC | 11d33e60-8c64-4316-a29a-d17e3e6e4a28 | 2026-08-11 | Warnings | M017 |
| Gee Gason | MALE GENITAL DESENSITIZER | Mon Gars Boutique Inc | 58c75e5c-b801-017f-e063-6394a90a1c75 | 2026-08-11 | Warnings | M017 |
| Capsaicin Cream | CAPSAICIN | Trifecta Pharmaceuticals USA LLC | 58c84330-15bf-c397-e063-6394a90aba05 | 2026-08-11 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE | TARGET Corporation | 4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5 | 2026-08-11 | Warnings | M017 |
| Itch Relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | CVS Pharmacy | 0e988da1-1904-431d-a152-bdb2aacc8e16 | 2026-08-11 | Warnings | M017 |
| Medicated BODY | MENTHOL | CVS Pharmacy, Inc. | a0f61498-69c8-4ce0-bbd7-3a807f192d36 | 2026-08-11 | Warnings | M017 |
| Muscle Move | MENTHOL | Saje Natural Wellness Inc. | 526d3305-4cf8-2fc5-e063-6394a90ad53b | 2026-08-10 | Warnings | M017 |
| Relieve and Relax Pain Relieving | CAMPHOR (SYNTHETIC), MENTHOL | MAC Innovations, LLC | c0528c36-d322-8110-e053-2995a90add6c | 2026-08-08 | Warnings | M017 |
| CVS Pain Relief | MENTHOL | CVS Pharmacy | 4aa629f5-8b8f-cc67-e063-6394a90a019f | 2026-08-07 | Warnings | M017 |
| Instant Cooling Itch Relief | HYDROCORTISONE | CVS Pharmacy | 46545d04-5958-d136-e063-6394a90a3462 | 2026-08-07 | Warnings | M017 |
| CVS Itch Relief | PRAMOXINE HYDROCHLORIDE, ZINC ACETATE | CVS Pharmacy | 46921bea-fcbe-94d6-e063-6394a90a726b | 2026-08-07 | Warnings | M017 |
| CVS Isopropyl Rubbing Alcohol | ISOPROPYL ALCOHOL | CVS Pharmacy | 524605f9-8b04-b600-e063-6394a90a4a02 | 2026-08-07 | Warnings | M017 |
| Lidonex | LIDOCAINE HCL, MENTHOL | Aldama Pharmaceuticals, Inc | 365cf19c-70e0-c4e9-e063-6294a90ac428 | 2026-08-07 | Warnings | M017 |
| Blaster Pain Relief Stick | MENTHOL, METHYL SALICYLATE, CAMPHOR | Kalahari Rose, LLC | 587d660a-5f80-de5a-e063-6394a90aa287 | 2026-08-07 | Warnings | M017 |
| Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Cardinal Health, 110 dba Leader | 3ed7b8a1-012f-459d-878c-813b93d4673c | 2026-08-06 | Warnings, Adverse reactions | M017 |
| Gel Cooling Pain Relief | MENTHOL | The Kroger Co. | 6fb0acc8-8dab-452c-b09e-de97306e1c32 | 2026-08-06 | Warnings, Adverse reactions | M017 |
| Lidocaine Tattoo Wipe | LIDOCAINE HYDROCHLORIDE | MD Tattoo Company | 369c1d16-597c-e1dc-e063-6394a90a3104 | 2026-08-06 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68678-040-90 | 68678004090 | 84 mL in 1 BOTTLE, DISPENSING (68678-040-90) | 84 ml | 2016-01-01 | 0000-00-00 | No | No | Current |