ActivICE
- Product NDC
- 53329-984
- 11-digit product format
- 533290984
- Labeler code
- 53329
- Product ID
- 53329-984_41d6f934-693e-24d3-e063-6294a90a2026
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- menthol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-03-04
- Substance
- MENTHOL
- Active strength
- 80 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ActivICE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 80 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | L7T10EIP3A |
| Rxcui | 283257, 2119857 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 111d457e-3138-4512-b0ba-d0cd760c4055 | Product name | 3 | 20250225 |
| 0426261e-1bb9-b78b-abd2-80da765a7e3e | Product name | 2 | 20240513 |
| 7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7 | Product name | 5 | 20240320 |
| 0ac2f11f-f58d-baf2-71a0-680993b48a61 | Product name | 2 | 20231211 |
| 855d63c3-b090-4636-8fc7-6d39ad23c44f | Product name | 1 | 20230829 |
| bb58f410-04be-65dd-9211-e89ead899698 | Product name | 6 | 20230323 |
| 0fcbc38a-8b29-3348-1cef-5222ea53484f | Product name | 4 | 20220516 |
| c4e1eedc-aca2-4551-8382-89144ed9d049 | Product name | 3 | 20220126 |
| 8d368a34-1453-43ea-828d-0dbcd72b8794 | Product name | 8 | 20210622 |
| d6bab9d2-edce-a213-4796-226ab15472c3 | Product name | 6 | 20200616 |
| 2487e6ef-d419-42fc-aaf8-7acc805d2370 | Product name | 2 | 20170718 |
| e071c814-e5e7-e7ed-ec76-428765d9c66b | Product name | 2 | 20151120 |
| 93148e06-b8d7-4e6c-853e-62f807d17fbb | Product name | 1 | 20151014 |
| dbb00be6-fb1c-4b0a-a770-31f7e05e247e | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53329-984-04 | ActivICE | 118 mL in 1 TUBE | GEL | 118 | 11 | |
| 53329-984-06 | ActivICE | 473 mL in 1 BOTTLE | GEL | 473 | 11 | |
| 53329-984-16 | ActivICE | 5.6 mL in 1 PACKET | GEL | 5.6 | 11 | |
| 53329-984-23 | ActivICE | 946 mL in 1 BOTTLE | GEL | 946 | 11 | |
| 53329-984-25 | ActivICE | 3785 mL in 1 BOTTLE | GEL | 3785 | 11 | |
| 53329-984-30 | ActivICE | 5.6 mL in 1 PACKET | GEL | 5.6 | 11 | |
| 53329-984-30 | ActivICE | 100 in 1 BOX | GEL | 100 | 11 | |
| 53329-984-16 | Diclovix M | 85 g in 1 PACKET | GEL | 85 g | 80 g in 1000g | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-984-16 | ML - Milliliter | 53329-984 | 6c576af8-8fb5-48c9-a559-ef13eb226fb1 | 1 | 2025-02-10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53329-984 | ACTIVICE (MENTHOL) GEL [MEDLINE INDUSTRIES, LP] | 10 | Current NDC, Legacy NDC, 7 package rows | 20241215_834adeb9-38ad-0cfe-e053-2991aa0af82f.zip |
| 53329-984 | DICLOVIX M (DICLOFENAC SODIUM, WITH CAMPHOR, LIDOCAINE, AND METHYL SALICYLATE PATCH) KIT [PRIMARY PHARMACEUTICALS, INC] | 1 | Current NDC, Legacy NDC | 20200126_9d0012ed-a50a-a936-e053-2995a90a6100.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2119857 | ActivICE 8 % Topical Gel | PSN | 834adeb9-38ad-0cfe-e053-2991aa0af82f | 11 |
| 283257 | menthol 8 % Topical Gel | PSN | 834adeb9-38ad-0cfe-e053-2991aa0af82f | 11 |
| 2119857 | menthol 0.08 MG/MG Topical Gel [ActivICE] | SBD | 834adeb9-38ad-0cfe-e053-2991aa0af82f | 11 |
| 283257 | menthol 0.08 MG/MG Topical Gel | SCD | 834adeb9-38ad-0cfe-e053-2991aa0af82f | 11 |
| 2119857 | ActivICE 0.08 MG/MG Topical Gel | SY | 834adeb9-38ad-0cfe-e053-2991aa0af82f | 11 |
| 283257 | menthol 8 % Topical Gel | SY | 834adeb9-38ad-0cfe-e053-2991aa0af82f | 11 |
| 2119857 | ActivICE 8 % Topical Gel | PSN | 9d0012ed-a50a-a936-e053-2995a90a6100 | 1 |
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | 9d0012ed-a50a-a936-e053-2995a90a6100 | 1 |
| 283257 | menthol 8 % Topical Gel | PSN | 9d0012ed-a50a-a936-e053-2995a90a6100 | 1 |
| 2119857 | menthol 0.08 MG/MG Topical Gel [ActivICE] | SBD | 9d0012ed-a50a-a936-e053-2995a90a6100 | 1 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | 9d0012ed-a50a-a936-e053-2995a90a6100 | 1 |
| 283257 | menthol 0.08 MG/MG Topical Gel | SCD | 9d0012ed-a50a-a936-e053-2995a90a6100 | 1 |
| 2119857 | ActivICE 0.08 MG/MG Topical Gel | SY | 9d0012ed-a50a-a936-e053-2995a90a6100 | 1 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | 9d0012ed-a50a-a936-e053-2995a90a6100 | 1 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | 9d0012ed-a50a-a936-e053-2995a90a6100 | 1 |
| 283257 | menthol 8 % Topical Gel | SY | 9d0012ed-a50a-a936-e053-2995a90a6100 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-984-04 | 53329098404 | 118 mL in 1 TUBE (53329-984-04) | 118 ml | 2019-03-04 | 0000-00-00 | No | No | Current |
| 53329-984-06 | 53329098406 | 473 mL in 1 BOTTLE (53329-984-06) | 473 ml | 2019-03-04 | 0000-00-00 | No | No | Current |
| 53329-984-16 | 53329098416 | 5.6 mL in 1 PACKET (53329-984-16) | 5.6 ml | 2019-03-04 | 0000-00-00 | No | No | Current |
| 53329-984-23 | 53329098423 | 946 mL in 1 BOTTLE (53329-984-23) | 946 ml | 2019-03-04 | 0000-00-00 | No | No | Current |
| 53329-984-25 | 53329098425 | 3785 mL in 1 BOTTLE (53329-984-25) | 3785 ml | 2019-03-04 | 0000-00-00 | No | No | Current |
| 53329-984-30 | 53329098430 | 100 PACKET in 1 BOX (53329-984-30) / 5.6 mL in 1 PACKET | 100 packet | 2019-03-04 | 0000-00-00 | No | No | Current |