Over-the-counter drug · OTC MONOGRAPH DRUG
Fargelin Hemorrhoidal NDC 55614-610
calamine, petrolatum and phenylephrine hydrochloride · Zinc oxide 10.3 g/100g + 3 more ingredients · Ointment · Rectal, Topical · MADISON ONE ACME INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55614-610-01 | 5561406100155614061001 | 20 g in 1 TUBE, WITH APPLICATOR (55614-610-01)Marketed from Nov 27, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Fargelin Hemorrhoidal
- Generic name (nonproprietary)
- calamine, petrolatum and phenylephrine hydrochloride
- Active ingredients
- Zinc oxide — 10.3 g/100gFerric oxide red — .05 g/100gPetrolatum — 79.25 g/100gPhenylephrine hydrochloride — .25 g/100g
- Dosage form
- Ointment
- Route
- Rectal, Topical
- Labeler
- MADISON ONE ACME INCNDC labeler code 55614
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 015
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 55614-610_43466548-41d6-9d96-e063-6294a90acd67SPL ID 43466548-41d6-9d96-e063-6294a90acd67SPL set ID 6844ad63-512d-496a-9458-011894185b0dUNII SOI2LOH54Z, 1K09F3G675, 4T6H12BN9U, 04JA59TNSJ
- Pharmacologic class
- alpha-1 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N455614061001followed by a unit qualifier and the quantityPackage 55614-0610-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily helps relieve: anorectal burning, itching, and discomfort associated with hemorrhoids temporarily: reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders shrinks hemorrhoidal tissue protects inflamed perianal skin and irritated areas
Excerpt only. Read the full label for complete information.
About NDC 55614-610
- What is NDC 55614-610?
- 55614-610 is the product NDC for Fargelin Hemorrhoidal, Zinc oxide 10.3 g/100g + 3 more ingredients ointment, listed with the FDA by MADISON ONE ACME INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fargelin Hemorrhoidal (Calamine, Petrolatum and Phenylephrine hydrochloride).
- What is the active ingredient?
- Zinc oxide, Ferric oxide red, Petrolatum, Phenylephrine hydrochloride.
- Who is the labeler?
- MADISON ONE ACME INC, NDC labeler code 55614. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fargelin Hemorrhoidal?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 015
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-094 |
| 0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Universal Distribution Center LLC | 52000-438 |
| 5% Lidocaine 10g5% lidocaine | Lidocaine 5 g/100g | CreamTopical | Chongqing Mandongzi Technology Co., Ltd | 88002-001 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangzhou Haishi Biological Technology Co., Ltd. | 60771-0028 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangzhou Haishi Biological Technology Co., Ltd. | 60771-0029 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-615 |
| Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangzhou Haishi Biological Technology Co., Ltd. | 60771-0041 |
| Adellina Lidocaine Numbing Cream Topical Anorectal Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-612 |
| Adellina Lidocaine Numbing Cream Topical Anorectal Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-614 |
| ADVANCED NUMB Topical Anestheticlidocaine hydrochloride | Lidocaine hydrochloride 50 mg/g | CreamTopical | Uber Scientific, LLC | 71131-052 |
| AER Pre-moistened Witch Hazel Padwitch hazel | Witch hazel 500 mg/mL | SolutionRectal, Topical | Birchwood Laboratories LLC | 50289-3250 |
| AER Traveler Toweletteaer traveler | Witch hazel .5 g/1 | SolutionRectal, Topical | Birchwood Laboratories LLC | 50289-4200 |
| Americainebenzocaine | Benzocaine 5.6 g/28g | OintmentTopical | Insight Pharmaceuticals LLC | 63736-375 |
| AnievaLClidocaine | Lidocaine .05 g/g | CreamTopical | Blackstone Products, LLC | 87798-001 |
| ANIXIKE Numbinglidocaine4% numbing | Lidocaine 4 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-166 |
| Arlun LIDOCAINE Creamlidocaine cream | Lidocaine 5 g/100g | CreamTopical | Guangzhou Jingliang Cosmetics Co., Ltd. | 87408-021 |
| Assured Bikini Smooth Creamlidocaine | Lidocaine 2 g/100g | CreamTopical | Zhejiang Jingwei Pharmaceutical Co., Ltd. | 55621-011 |
| Asteroidmenthol, petrolatum, zinc oxide | Menthol .098 g/28g + 2 more ingredients | OintmentTopical | HEALTHTEX LIMITED | 84107-552 |
| B-SURE Traveler Toweletteb-sure traveler | Witch hazel .5 g/g | SolutionRectal, Topical | Birchwood Laboratories LLC | 50289-9250 |
| Barrier Protectant Creambarrier cream | Menthol 1 mg/g; Zinc oxide 200 mg/g | OintmentTopical | Cardinal Health | 63517-003 |
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