Cold Spot
- Product NDC
- 65121-001
- 11-digit product format
- 651210001
- Labeler code
- 65121
- Product ID
- 65121-001_ea738ac3-347b-4fbd-a049-1893172a18e8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- menthol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Pure Source
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2010-08-24
- Marketing end
- 0000-00-00
- Substance
- MENTHOL
- Active strength
- 0 L/3.8L
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65121-001-00 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c1d0-8e05-e053-dbdaa90a074a | Cold Spot Point Relief Pain relieving Gel - 5 G |
| 65121-001-04 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d9dc-8e05-e053-dbdaa90a074a | Cold Spot Point Relief Pain relieving Spray - 4 oz. gel |
| 65121-001-16 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d280-8e05-e053-dbdaa90a074a | Cold Spot Point Relief Pain relieving Gel - 16 oz. |
| 65121-001-28 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d16f-8e05-e053-dbdaa90a074a | Cold Spot Point Relief Pain relieving Gel - 1 Gallon |
| 65121-001-32 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c806-8e05-e053-dbdaa90a074a | Cold Spot Point Relief Pain relieving Gel - 32 oz. |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65121-001-04 | Cold SpotPoint Relief | 120 mL in 1 TUBE | GEL | 120 | 12 | |
| 65121-001-32 | Cold SpotPoint Relief | 960 mL in 1 CONTAINER | GEL | 960 | 10 | |
| 65121-001-16 | Cold SpotPoint Relief | 480 mL in 1 CONTAINER | GEL | 480 | 6 | |
| 65121-001-00 | Cold SpotPoint Relief | 5 g in 1 BOTTLE, DISPENSING | GEL | 5 | 5 | |
| 65121-001-28 | Cold SpotPoint Relief | 3.8 L in 1 BOTTLE, PUMP | GEL | 3.8 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65121-001 | COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [PURE SOURCE] | 12 | Legacy NDC, 1 package rows | 20101206_7b1f8b2a-3d6c-4696-a9cf-c9a98b01af86.zip |
| 65121-001 | COLD SPOT POINT RELIEF (MENTHOL, METHYL SALICYLATE) GEL [PURE SOURCE] | 10 | Legacy NDC, 1 package rows | 20101206_77147673-dc43-43c0-83a8-d71942ecbe25.zip |
| 65121-001 | COLD SPOT POINT RELIEF (MENTHOL) GEL [PURE SOURCE] | 6 | Legacy NDC, 1 package rows | 20101112_50d6008a-43c6-4cfd-8e56-e29e66097d6c.zip |
| 65121-001 | COLD SPOT POINT RELIEF (MENTHOL) GEL [PURE SOURCE] | 5 | Legacy NDC, 1 package rows | 20101112_1b2efd8c-1878-43d6-b7e5-d431852e8a10.zip |
| 65121-001 | COLD SPOT POINT RELIEF (MENTHOL) GEL [PURE SOURCE] | 3 | Legacy NDC, 1 package rows | 20101018_21b499f3-99a1-446d-a113-d36faff66f23.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1235996 | ColdSpot POINT RELIEF 12 % / 4 % Topical Gel | PSN | 7b1f8b2a-3d6c-4696-a9cf-c9a98b01af86 | 12 |
| 1045442 | menthol 12 % / methyl salicylate 4 % Topical Gel | PSN | 7b1f8b2a-3d6c-4696-a9cf-c9a98b01af86 | 12 |
| 1235996 | menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel [Cold Spot with Methyl Salicylate] | SBD | 7b1f8b2a-3d6c-4696-a9cf-c9a98b01af86 | 12 |
| 1045442 | menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel | SCD | 7b1f8b2a-3d6c-4696-a9cf-c9a98b01af86 | 12 |
| 1235996 | Cold Spot Point Relief with Methyl Salicylate (menthol 12 % / methyl salicylate 4 % ) Topical Gel | SY | 7b1f8b2a-3d6c-4696-a9cf-c9a98b01af86 | 12 |
| 1235996 | Cold Spot with Methyl Salicylate (menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG) Topical Gel | SY | 7b1f8b2a-3d6c-4696-a9cf-c9a98b01af86 | 12 |
| 1045442 | menthol 12 % / methyl salicylate 4 % Topical Gel | SY | 7b1f8b2a-3d6c-4696-a9cf-c9a98b01af86 | 12 |
| 1235996 | ColdSpot POINT RELIEF 12 % / 4 % Topical Gel | PSN | 77147673-dc43-43c0-83a8-d71942ecbe25 | 10 |
| 1045442 | menthol 12 % / methyl salicylate 4 % Topical Gel | PSN | 77147673-dc43-43c0-83a8-d71942ecbe25 | 10 |
| 1235996 | menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel [Cold Spot with Methyl Salicylate] | SBD | 77147673-dc43-43c0-83a8-d71942ecbe25 | 10 |
| 1045442 | menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel | SCD | 77147673-dc43-43c0-83a8-d71942ecbe25 | 10 |
| 1235996 | Cold Spot Point Relief with Methyl Salicylate (menthol 12 % / methyl salicylate 4 % ) Topical Gel | SY | 77147673-dc43-43c0-83a8-d71942ecbe25 | 10 |
| 1235996 | Cold Spot with Methyl Salicylate (menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG) Topical Gel | SY | 77147673-dc43-43c0-83a8-d71942ecbe25 | 10 |
| 1045442 | menthol 12 % / methyl salicylate 4 % Topical Gel | SY | 77147673-dc43-43c0-83a8-d71942ecbe25 | 10 |
| 1235996 | ColdSpot POINT RELIEF 12 % / 4 % Topical Gel | PSN | 50d6008a-43c6-4cfd-8e56-e29e66097d6c | 6 |
| 1045442 | menthol 12 % / methyl salicylate 4 % Topical Gel | PSN | 50d6008a-43c6-4cfd-8e56-e29e66097d6c | 6 |
| 1235996 | menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel [Cold Spot with Methyl Salicylate] | SBD | 50d6008a-43c6-4cfd-8e56-e29e66097d6c | 6 |
| 1045442 | menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel | SCD | 50d6008a-43c6-4cfd-8e56-e29e66097d6c | 6 |
| 1235996 | Cold Spot Point Relief with Methyl Salicylate (menthol 12 % / methyl salicylate 4 % ) Topical Gel | SY | 50d6008a-43c6-4cfd-8e56-e29e66097d6c | 6 |
| 1235996 | Cold Spot with Methyl Salicylate (menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG) Topical Gel | SY | 50d6008a-43c6-4cfd-8e56-e29e66097d6c | 6 |
| 1045442 | menthol 12 % / methyl salicylate 4 % Topical Gel | SY | 50d6008a-43c6-4cfd-8e56-e29e66097d6c | 6 |
| 1235996 | ColdSpot POINT RELIEF 12 % / 4 % Topical Gel | PSN | 1b2efd8c-1878-43d6-b7e5-d431852e8a10 | 5 |
| 1045442 | menthol 12 % / methyl salicylate 4 % Topical Gel | PSN | 1b2efd8c-1878-43d6-b7e5-d431852e8a10 | 5 |
| 1235996 | menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel [Cold Spot with Methyl Salicylate] | SBD | 1b2efd8c-1878-43d6-b7e5-d431852e8a10 | 5 |
| 1045442 | menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel | SCD | 1b2efd8c-1878-43d6-b7e5-d431852e8a10 | 5 |
| 1235996 | Cold Spot Point Relief with Methyl Salicylate (menthol 12 % / methyl salicylate 4 % ) Topical Gel | SY | 1b2efd8c-1878-43d6-b7e5-d431852e8a10 | 5 |
| 1235996 | Cold Spot with Methyl Salicylate (menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG) Topical Gel | SY | 1b2efd8c-1878-43d6-b7e5-d431852e8a10 | 5 |
| 1045442 | menthol 12 % / methyl salicylate 4 % Topical Gel | SY | 1b2efd8c-1878-43d6-b7e5-d431852e8a10 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 65121-001-00 | 65121000100 | 5 g in 1 BOTTLE, DISPENSING | 5 g | Historical |
| 65121-001-04 | 65121000104 | 120 mL in 1 TUBE | 120 ml | Historical |
| 65121-001-16 | 65121000116 | 480 mL in 1 CONTAINER | 480 ml | Historical |
| 65121-001-28 | 65121000128 | 3.8 L in 1 BOTTLE, PUMP | 3.8 l | Historical |
| 65121-001-32 | 65121000132 | 960 mL in 1 CONTAINER | 960 ml | Historical |