83566-201 NDC - MOUTH RINSE ()

Drug Information

  • Product NDC: 83566-201
  • Proprietary Name: Mouth Rinse
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Guangdong Aimu Biological Technology Co., Ltd
Product Type:
FDA Application Number: M021
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:11/21/2023

Package Information

No. Package Code Package Description Billing Unit
183566-201-0110 mL in 1 DOSE PACK (83566-201-01)
283566-201-0212 mL in 1 CUP (83566-201-02)
383566-201-0350 mL in 1 BOTTLE (83566-201-03)
483566-201-0480 mL in 1 BOTTLE (83566-201-04)
583566-201-05100 mL in 1 BOTTLE (83566-201-05)
683566-201-06120 mL in 1 BOTTLE (83566-201-06)
783566-201-07180 mL in 1 BOTTLE (83566-201-07)
883566-201-08250 mL in 1 BOTTLE (83566-201-08)
983566-201-09300 mL in 1 BOTTLE (83566-201-09)
1083566-201-10450 mL in 1 BOTTLE (83566-201-10)
1183566-201-11480 mL in 1 BOTTLE (83566-201-11)
1283566-201-12500 mL in 1 BOTTLE (83566-201-12)
1383566-201-131000 mL in 1 BOTTLE (83566-201-13)
1483566-201-141438 mL in 1 BOTTLE (83566-201-14)
1583566-201-151500 mL in 1 BOTTLE (83566-201-15)

NDC Record

Field Name Field Value Definition
PRODUCT NDC83566-201The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEMouth RinseThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE11/21/2023This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERM021This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEGuangdong Aimu Biological Technology Co., LtdName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 8/8/2025

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