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 |
|---|---|---|---|---|---|---|
| Healing Hand Cream 2000mg | MENTHOL | Carolina Cannabis Creations LLC | 01f8795b-9f95-c793-e063-6394a90a8330 | 2025-01-15 | Warnings | M017 |
| CBD Clinic Deep-Rub Pain Relief - Level 5 | CAMPHOR, MENTHOL | ABACUS HEALTH PRODUCTS, INC. | 31e2e5cd-d33e-f058-e063-6394a90af7d2 | 2025-01-14 | Warnings | M017 |
| Meijer Odor Free Analgesic Pain Relieving Topical Analgesic | LIDOCAINE HYDROCHLORIDE | Meijer Distribution, Inc | 6288efea-f636-4eea-bb9f-78aa2f9af54a | 2025-01-14 | Warnings | M017 |
| IKONIK TONIK | LIDOCAINE HYDROCHLORIDE | IKONIK CARE, LLC | 122fdfe8-b5fa-46d1-9fd9-3df9887ed320 | 2025-01-14 | Warnings | M017 |
| elp essential MANTECA DE UBRE | METHYL SALICYLATE, CAMPHOR | Miramar Cosmetics, Inc DBA Miramar Lab | c3964dfe-17fe-4d89-a4c4-cf500f982259 | 2025-01-13 | Warnings | M017 |
| Methylten | METHYL SALICYLATE 10% | Puretek Corporation | 28f4093f-803f-0e70-e063-6294a90a98a4 | 2025-01-13 | Warnings | M017 |
| Refill Bundle 7 Large Office | BENZALKONIUM CHLORIDE | CMC Group, Inc. | 6620a8f3-098d-d045-e053-2a91aa0a0d94 | 2025-01-13 | Warnings | M017 |
| Jakwork Numbing Cream | NUMBING CREAM | Guangzhou Zanming Trading Co., Ltd. | 2ba1de83-494a-6c54-e063-6294a90a9b2d | 2025-01-13 | Warnings | M017 |
| Arthritis Hot | MENTHOL AND METHYL SALICYLATE | Chattem, Inc. | cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd | 2025-01-13 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 00b40dda-53ad-0458-e063-6394a90aa835 | 2025-01-11 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 00b47eb7-6b43-d9e2-e063-6294a90a9a38 | 2025-01-11 | Warnings | M017 |
| Re-Lieved 4% Lidocaine Fabric Tape | LIDOCAINE 4% FABRIC TAPE | Transfer Technology | e9a894b0-54f2-707e-e053-2a95a90a0f0d | 2025-01-11 | Warnings | M017 |
| Re-Lieved 3 in 1 Patch | MENTHOL, CAMPHOR, METHYL SALICYLATE PATCH | Transfer Technology | e9ab9a03-b9e3-7317-e053-2995a90a9950 | 2025-01-11 | Warnings | M017 |
| ASTRAPHARM CHILLI BRAND | CAPSAICIN | Dersan Pharmaceutical Co., Ltd | b4c2d4fd-7d5d-4156-ac27-e72ebc9671ec | 2025-01-10 | Warnings | M017 |
| LABOFLEX Lidocaine Pain Relieving Patch | LIDOCAINE 4% | Laboflex, Inc. | 31995f31-c272-afdb-e063-6294a90af3f9 | 2025-01-10 | Warnings | M017 |
| Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1% | Chain Drug Marketing Association Inc. | 2b48cb2f-e6bf-f9de-e063-6394a90a42d4 | 2025-01-09 | Warnings | M017 |
| PAIN-X | MENTHOL | OL PHARMA TECH,LLC | b22bb19a-14e5-3d32-e053-2a95a90ae520 | 2025-01-09 | Warnings | M017 |
| MUSCLE RUB | MENTHOL | OL PHARMA TECH,LLC | b22c7999-52d5-25c3-e053-2a95a90a01f5 | 2025-01-09 | Warnings | M017 |
| Biofreeze Professional Colorless Roll-On | MENTHOL, UNSPECIFIED FORM | A-S Medication Solutions | ce392c4f-cc43-484d-9c49-18fa25e4e5e9 | 2025-01-09 | Warnings | M017 |
| NEW TEROCIN | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | A-S Medication Solutions | 43e5eb27-5541-4b7b-80de-55a79a4dce55 | 2025-01-09 | 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 |