What is NDC 0362-3971?

0362-3971 is the product NDC for DycloPro (dyclonine hydrochloride), Dyclonine hydrochloride 5 mg/mL solution, listed with the FDA by Septodont Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

DycloPro (Dyclonine Hydrochloride).

Septodont Inc, NDC labeler code 0362. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for DycloPro?

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.

DycloPro NDC 0362-3971 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0362-3971Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00362-3971Add 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 NDC	11-digit (billing)	Package	Copy
0362-3971-05	0036239710500362397105	1 BOTTLE in 1 BOTTLE (0362-3971-05) / 30 mL in 1 BOTTLEMarketed from Sep 1, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): DycloPro
Generic name (nonproprietary): dyclonine hydrochloride
Active ingredients: Dyclonine hydrochloride — 5 mg/mL
Dosage form: Solution
Route: Topical
Labeler: Septodont IncNDC labeler code 0362
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200480
Marketing start: Sep 1, 2019
Listing expires: Dec 31, 2027
Identifiers: Product ID 0362-3971_639ddf01-a839-45be-b9a7-11f27394c799SPL ID 639ddf01-a839-45be-b9a7-11f27394c799SPL set ID bfd9a2dd-7b40-40c0-b256-52f613395760RxCUI 1048281, 2199132UNII ZEC193879Q

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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400362397105 followed by a unit qualifier and the quantity

Package 00362-3971-05. 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 Nov 28, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Dyclonine HCl Topical Solution, USP is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures. Dyclonine HCl Topical Solution, USP, 0.5% topical anesthetic may also be used to block the gag reflex, to relieve the pain of oral ulcers or stomatitis and to relieve pain associated with ano-genital lesions.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0362-3971

What is NDC 0362-3971?: 0362-3971 is the product NDC for DycloPro (dyclonine hydrochloride), Dyclonine hydrochloride 5 mg/mL solution, listed with the FDA by Septodont Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: DycloPro (Dyclonine Hydrochloride).
What is the active ingredient?: Dyclonine hydrochloride.
Who is the labeler?: Septodont Inc, NDC labeler code 0362. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for DycloPro?: 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.

DycloPro (Dyclonine hydrochloride) NDC 0362-3971