Cooling Gel
- Product NDC
- 13709-354
- 11-digit product format
- 137090354
- Labeler code
- 13709
- Product ID
- 13709-354_49fb637b-ecc6-1f9b-e063-6294a90ab41a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pain Relief Cooling Gel
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- NeilMed Pharmaceuticals Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-02-04
- Substance
- PHENYLEPHRINE; WITCH HAZEL
- Active strength
- 2.5; 500 mg/g; mg/g
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cooling Gel
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYLEPHRINE | 2.5 mg/g |
| WITCH HAZEL | 500 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1WS297W6MV, 101I4J0U34 |
| Rxcui | 249465 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13709-354-01 | Cooling Gel | 25.5 g in 1 TUBE | GEL | 25.5 | | 1 |
| 13709-354-01 | Cooling Gel | 1 in 1 CARTON | GEL | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 13709-354-01 | 13709035401 | 1 TUBE in 1 CARTON (13709-354-01) / 25.5 g in 1 TUBE | 1 tube | 2026-02-04 | No | No | Historical |