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 |
|---|---|---|---|---|---|---|
| La Vaquita New Regular | METHYL SALICYLATE | Delon Laboratories (1990) Ltd | d62186ac-afbb-443e-98c2-f0d122422a3c | 2026-09-01 | Warnings | M017 |
| ActivICE | MENTHOL | Medline Industries, LP | 834adeb9-38ad-0cfe-e053-2991aa0af82f | 2026-09-01 | Warnings | M017 |
| La Vaquita New Extra | METHYL SALICYLATE, MENTHOL | Delon Laboratories (1990) Ltd | 3097a01b-cee5-492f-b65a-63992fb28e3a | 2026-09-01 | Warnings | M017 |
| Terramed Just Think Comfort Hydrocortisone 1% Cream | HYDROCORTISONE | Rida LLC | 0d2c0c2c-370f-4adb-b0ea-1e218c927f8b | 2026-09-01 | Warnings | M017 |
| Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | HyVee Inc | 53157137-b980-45d2-aa10-8c111c0ec2f4 | 2026-08-31 | Warnings | M017 |
| EAYONYUMT NECK PAIN RELIEF | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a450e68-07a7-a4bb-e063-6294a90a97c9 | 2026-08-30 | Warnings | M017 |
| EAYONYUM BACK PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a458280-4f9c-5af6-e063-6394a90acb2e | 2026-08-30 | Warnings | M017 |
| EAYONYUM KNEE PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a45d19f-c753-71eb-e063-6294a90a4805 | 2026-08-30 | Warnings | M017 |
| Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin | HYDROCORTISONE | AmerisourceBergen | c5c5b5ca-b4d4-4fa8-b647-b3ccb2966495 | 2026-08-30 | Warnings | M017 |
| Olu Pain Management | LIDOCAINE AND CAMPHOR | HAWAII REPACK, INC. | 31ed3d82-ba12-46b2-b0ec-7e5e019efc10 | 2026-08-28 | Warnings | M017 |
| 4% Lidocaine Patches | 4% LIDOCAINE PATCHES | Shenzhen Chaoxiji Technology Co.,Ltd. | 5a177987-7c05-f07f-e063-6394a90aa9ba | 2026-08-28 | Warnings | M017 |
| Relieved Pro Wrap | 4% LIDOCAINE PATCH | Transfer Technology | 5a1c6ebf-ad3f-c47b-e063-6294a90aa19a | 2026-08-28 | Warnings | M017 |
| Sinsinpas Arex Pain Relieving Patch, Medium | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 46453ef2-512b-4852-e063-6394a90a8912 | 2026-08-28 | Warnings | M017 |
| Sinsinpas arex patch large | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 47c242da-56cd-bea1-e063-6394a90a41de | 2026-08-28 | Warnings | M017 |
| Eagle Brand Eagle Balm | CAMPHOR, MENTHOL | PT. EAGLE INDO PHARMA | 0ba74dba-ec98-09d7-e063-6394a90a22db | 2026-08-27 | Warnings | M017 |
| 4% Lidocaine Patches | 4% LIDOCAINE PATCHES | Shenzhen Chaoxiji Technology Co.,Ltd. | 5a16c6aa-3ab0-3e46-e063-6294a90a6d8f | 2026-08-27 | Warnings | M017 |
| Lidocaine Patch 4% | LIDOCAINE 4% | Global America Group LLC | 1eec782d-0e56-43d2-b842-da0ae47c5dc9 | 2026-08-26 | Warnings | M017 |
| Careland Lidocaine Plus Menthol Pain Relieving | LIDOCAINE, MENTHOL | Planet (Anhui) Pharmaceutical Co., Ltd | 0f928b5b-60f5-4a45-a409-c601eb330487 | 2026-08-26 | Warnings | M017 |
| PARCHE CALIENTE | CAPSAICINA AND MENTOL | DW SUPPORT LLC | 59f2708e-295a-ccb3-e063-6394a90ad395 | 2026-08-26 | Warnings | M017 |
| CVS Pain Relief | LIDOCAINE | CVS Pharmacy | 4ecbc263-e0d4-18d5-e063-6294a90a72e9 | 2026-08-26 | 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 |