FARGELIN HEMORRHOIDAL
- Product NDC
- 55614-610
- 11-digit product format
- 556140610
- Labeler code
- 55614
- Product ID
- 55614-610_43466548-41d6-9d96-e063-6294a90acd67
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calamine, Petrolatum and Phenylephrine hydrochloride
- Dosage form
- OINTMENT
- Route
- RECTAL; TOPICAL
- Labeler
- MADISON ONE ACME INC
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-11-27
- Substance
- FERRIC OXIDE RED; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; ZINC OXIDE
- Active strength
- .05; 79.25; .25; 10.3 g/100g; g/100g; 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
- FARGELIN HEMORRHOIDAL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FERRIC OXIDE RED | .05 g/100g |
| PETROLATUM | 79.25 g/100g |
| PHENYLEPHRINE HYDROCHLORIDE | .25 g/100g |
| ZINC OXIDE | 10.3 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1K09F3G675, 4T6H12BN9U, 04JA59TNSJ, SOI2LOH54Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55614-610-01 | FARGELIN HEMORRHOIDAL | 20 g in 1 TUBE, WITH APPLICATOR | OINTMENT | 20 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55614-610 | FARGELIN HEMORRHOIDAL (CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE) OINTMENT [MADISON ONE ACME INC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241127_6844ad63-512d-496a-9458-011894185b0d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55614-610-01 | 55614061001 | 20 g in 1 TUBE, WITH APPLICATOR (55614-610-01) | 20 g | 2019-11-27 | 0000-00-00 | No | No | Current |