NDC codes

FDA NDC Directory
Product NDC (as listed)55614-610Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55614-0610Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
55614-610-01556140610015561406100120 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

N455614061001 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under M 015
ProductStrengthForm · routeLabelerProduct NDC
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochlorideMineral oil 14 g/100g + 2 more ingredientsOintmentTopicalNantong Health & Beyond Hygienic Products Inc.43473-094
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochlorideMineral oil 14 g/100g + 2 more ingredientsOintmentTopicalUniversal Distribution Center LLC52000-438
5% Lidocaine 10g5% lidocaineLidocaine 5 g/100gCreamTopicalChongqing Mandongzi Technology Co., Ltd88002-001
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangzhou Haishi Biological Technology Co., Ltd.60771-0028
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangzhou Haishi Biological Technology Co., Ltd.60771-0029
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangdong Aimu Biological Technology Co., Ltd83566-615
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangzhou Haishi Biological Technology Co., Ltd.60771-0041
Adellina Lidocaine Numbing Cream Topical Anorectal CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangdong Aimu Biological Technology Co., Ltd83566-612
Adellina Lidocaine Numbing Cream Topical Anorectal CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangdong Aimu Biological Technology Co., Ltd83566-614
ADVANCED NUMB Topical Anestheticlidocaine hydrochlorideLidocaine hydrochloride 50 mg/gCreamTopicalUber Scientific, LLC71131-052
AER Pre-moistened Witch Hazel Padwitch hazelWitch hazel 500 mg/mLSolutionRectal, TopicalBirchwood Laboratories LLC50289-3250
AER Traveler Toweletteaer travelerWitch hazel .5 g/1SolutionRectal, TopicalBirchwood Laboratories LLC50289-4200
AmericainebenzocaineBenzocaine 5.6 g/28gOintmentTopicalInsight Pharmaceuticals LLC63736-375
AnievaLClidocaineLidocaine .05 g/gCreamTopicalBlackstone Products, LLC87798-001
ANIXIKE Numbinglidocaine4% numbingLidocaine 4 g/100gCreamTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-166
Arlun LIDOCAINE Creamlidocaine creamLidocaine 5 g/100gCreamTopicalGuangzhou Jingliang Cosmetics Co., Ltd.87408-021
Assured Bikini Smooth CreamlidocaineLidocaine 2 g/100gCreamTopicalZhejiang Jingwei Pharmaceutical Co., Ltd.55621-011
Asteroidmenthol, petrolatum, zinc oxideMenthol .098 g/28g + 2 more ingredientsOintmentTopicalHEALTHTEX LIMITED84107-552
B-SURE Traveler Toweletteb-sure travelerWitch hazel .5 g/gSolutionRectal, TopicalBirchwood Laboratories LLC50289-9250
Barrier Protectant Creambarrier creamMenthol 1 mg/g; Zinc oxide 200 mg/gOintmentTopicalCardinal Health63517-003

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