Hemorroidal Cooling gel
- Product NDC
- 68016-054
- 11-digit product format
- 680160054
- Labeler code
- 68016
- Product ID
- 68016-054_29b73242-ddd9-37e0-e063-6394a90a7da9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Phenylephrine, Witch Hazel
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Pharmacy Value Alliance, LLC
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-08-02
- Substance
- PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
- Active strength
- .25; .5 g/100g; g/100g
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hemorroidal Cooling gel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYLEPHRINE HYDROCHLORIDE | .25 g/100g |
| WITCH HAZEL | .5 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04JA59TNSJ, 101I4J0U34 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68016-054-09 | Hemorroidal Cooling gel | 1 in 1 BOX | GEL | 1 | | 4 |
| 68016-054-09 | Hemorroidal Cooling gel | 26 g in 1 TUBE | GEL | 26 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-054 | HEMORROIDAL COOLING GEL (PHENYLEPHRINE, WITCH HAZEL) GEL [PHARMACY VALUE ALLIANCE, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241222_7276aab8-0297-2a55-e053-2a91aa0a8d21.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68016-054-09 | 68016005409 | 1 TUBE in 1 BOX (68016-054-09) / 26 g in 1 TUBE | 1 tube | 2018-08-02 | 0000-00-00 | No | No | Current |