Cold Therapy
- Product NDC
- 68678-011
- Requested package NDC
- 68678-011-17
- 11-digit product format
- 686780011
- Labeler code
- 68678
- Product ID
- 68678-011_3dd632d6-58a1-ab21-e063-6394a90a850c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- AHC VENTURES CORP DBA CRYODERM
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-01-01
- Substance
- MENTHOL
- Active strength
- 10 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | 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
- Cold Therapy
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 10 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 259249 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 90334420-5f81-4284-9a57-42e134ce362f | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68678-011-05 | Cold Therapy | 126 mL in 1 BOTTLE, DISPENSING | GEL | 126 | 4 | |
| 68678-011-17 | Cold Therapy | 504 mL in 1 BOTTLE, DISPENSING | GEL | 504 | 4 | |
| 68678-011-99 | Cold Therapy | 3 mL in 1 PACKET | GEL | 3 | 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 |
|---|---|---|---|---|---|---|
| JenGufun LIDOCAINE KNEE Patch | LIDOCAINE KNEE PATCH | Henan Kangdi Medical Devices Co., Ltd. | 5b1d8508-b993-7a8d-e063-6294a90ae306 | 2026-09-10 | Warnings | M017 |
| Wart Corn Remover | SALICYLIC ACID | HONG KONG FOREVER YOUNG TRADING CO., LIMITED | 5b0cd6e0-f220-4ebd-e063-6294a90ade67 | 2026-09-09 | Warnings | M017 |
| Magic Cream | PAIN RELIEVING OINTMENT | Jiangxi Baikang Medical Products Co., Ltd. | 5b0f2515-47e9-603f-e063-6294a90af9d4 | 2026-09-09 | Warnings | M017 |
| Burn Gel | LIDOCAINE HCI | Trifecta Pharmaceuticals USA LLC | e9d3e9be-1036-fad0-e053-2a95a90a6efe | 2026-09-09 | Warnings | M017 |
| 4% Lidocaine Pain Relief Patch | LIDOCAINE 4% | Guangxi Keyun E-commerce Co., Ltd. | 5b197cd8-542f-38b4-e063-6294a90ad7d3 | 2026-09-09 | Warnings | M017 |
| Pain Relieving Lidocaine Patch | LIDOCAINE | YYBA CORP | af8c84fd-224c-72b3-e053-2a95a90a9568 | 2026-09-07 | Warnings | M017 |
| American Safety First Aid | LIDOCAINE HCL | Orazen Inc | ea2f776b-dfd0-6ce4-e053-2995a90af009 | 2026-09-07 | Warnings | M017 |
| MEDI-FIRST Topical Analgesic | LIDOCAINE HCI | Ultra Distributors Inc | b6f288f7-9ae3-215e-e053-2a95a90aedf6 | 2026-09-07 | Warnings | M017 |
| MEDI-FIRST | BENZALKONIUM CHLORIDE, LIDOCAINE | Orazen Inc | f508434f-5948-7134-e053-2a95a90a03d7 | 2026-09-05 | Warnings | M017 |
| MEDI-FIRST | BENZALKONIUM CHLORIDE, LIDOCAINE | Orazen Inc | f522fb0b-3d86-b228-e053-2a95a90a55e9 | 2026-09-05 | Warnings | M017 |
| SurviveX Anti-itch Cream | SURVIVEX HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | 5a7a1141-d3b1-0ee8-e063-6294a90a16aa | 2026-09-04 | Warnings | M017 |
| NeuroNesic Pain Relieving Cream | CAPSAICIN | Blaine Labs Inc. | 7107c13d-bf59-4c0a-84fe-725a9fca2691 | 2026-09-04 | Warnings | M017 |
| Neoteric Diabetic Skin Care 1 oz. | DIMETHICONE | RNA PHARMA LLC | 5a944486-9591-f583-e063-6394a90aa04b | 2026-09-03 | Warnings | M017 |
| Equate Menthol Pain Relieving | MENTHOL | Wal-Mart Stores Inc | d5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc | 2026-09-03 | Warnings | M017 |
| ZHI Technologies | LIDOCAINE, MENTHOL | ZHI Technologies, Inc. | 6717e995-4d2d-49e8-8ecf-7c62557dfdef | 2026-09-03 | Warnings | M017 |
| Komxsum LIDOCAINE Cream | LIDOCAINE 4% CREAM | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5a9feae0-9be4-e736-e063-6294a90abe55 | 2026-09-03 | Warnings | M017 |
| FREEZE EASE Roll-On | MENTHOL | Global America Group LLC | 1869cc0d-a056-45de-aede-23b09b61ed12 | 2026-09-02 | Warnings | M017 |
| Gaimoa Lidocaine Pain Relief Gel Patches | LIDOCAINE PAIN RELIEF GEL PATCHES | Henan Enokon Medical Instrument Co., Ltd. | 5a68fe67-5c15-af9a-e063-6294a90a7ec1 | 2026-09-01 | Warnings | M017 |
| CVS Cortisone Liquid | HYDROCORTISONE | CVS Pharmacy | 42df45a9-d449-090a-e063-6394a90a9ee4 | 2026-09-01 | Warnings | M017 |
| Ramedica Herbal Wonder Balm | CAMPHOR, MENTHOL | Ramedicare Sdn. Bhd. | cfb2ea0e-a1f6-4fdf-b866-346bbe78788f | 2026-09-01 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 259249 | menthol 10 % Topical Gel | PSN | 90334420-5f81-4284-9a57-42e134ce362f | 4 |
| 259249 | menthol 0.1 MG/MG Topical Gel | SCD | 90334420-5f81-4284-9a57-42e134ce362f | 4 |
| 259249 | menthol 10 % Topical Gel | SY | 90334420-5f81-4284-9a57-42e134ce362f | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68678-011-17 | 68678001117 | 504 mL in 1 BOTTLE, DISPENSING (68678-011-17) | 504 ml | 2016-01-01 | 0000-00-00 | No | No | Current |