dyclopro

Generic: dyclonine hydrochloride

Labeler: septodont inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dyclopro
Generic Name dyclonine hydrochloride
Labeler septodont inc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

dyclonine hydrochloride 5 mg/mL

Manufacturer
Septodont Inc

Identifiers & Regulatory

Product NDC 0362-3971
Product ID 0362-3971_639ddf01-a839-45be-b9a7-11f27394c799
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200480
Listing Expiration 2026-12-31
Marketing Start 2019-09-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03623971
Hyphenated Format 0362-3971

Supplemental Identifiers

RxCUI
1048281 2199132
UNII
ZEC193879Q

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dyclopro (source: ndc)
Generic Name dyclonine hydrochloride (source: ndc)
Application Number ANDA200480 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOTTLE (0362-3971-05) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

0362-3971-05 1 BOTTLE in 1 BOTTLE (0362-3971-05) / 30 mL in 1 BOTTLE

Ingredients (1)

dyclonine hydrochloride (5 mg/mL)

Linked Drug Pages (1)

DycloPro ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "639ddf01-a839-45be-b9a7-11f27394c799", "openfda": {"unii": ["ZEC193879Q"], "rxcui": ["1048281", "2199132"], "spl_set_id": ["bfd9a2dd-7b40-40c0-b256-52f613395760"], "manufacturer_name": ["Septodont Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOTTLE (0362-3971-05)  / 30 mL in 1 BOTTLE", "package_ndc": "0362-3971-05", "marketing_start_date": "20190901"}], "brand_name": "DycloPro", "product_id": "0362-3971_639ddf01-a839-45be-b9a7-11f27394c799", "dosage_form": "SOLUTION", "product_ndc": "0362-3971", "generic_name": "Dyclonine Hydrochloride", "labeler_name": "Septodont Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DycloPro", "active_ingredients": [{"name": "DYCLONINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA200480", "marketing_category": "ANDA", "marketing_start_date": "20190901", "listing_expiration_date": "20261231"}