81469-999 NDC - ASTRINGENT SOLUTION (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE)

Drug Information

  • Product NDC: 81469-999
  • Proprietary Name: Astringent Solution
  • Non Proprietary Name: Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate
  • Active Ingredient(s): 1347 mg/2299mg ALUMINUM SULFATE TETRADECAHYDRATE; 952 mg/2299mg CALCIUM ACETATE MONOHYDRATE
  • Administration Route(s): TOPICAL
  • Dosage Form(s): POWDER, FOR SOLUTION
  • Pharmacy Class(es): Blood Coagulation Factor [EPC]; Calcium [CS]; Cations; Divalent [CS]; Increased Coagulation Factor Activity [PE]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]

Labeler Information

Field Name Field Value
Labeler Name: First Nation Group
Product Type: HUMAN OTC DRUG
FDA Application Number: M016
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:9/27/2023

Package Information

No. Package Code Package Description Billing Unit
181469-999-1212 PACKET in 1 BOX (81469-999-12) / 2299 mg in 1 PACKET (81469-999-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC81469-999The 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.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEAstringent SolutionThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAluminum Sulfate Tetradecahydrate, Calcium Acetate MonohydrateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDER, FOR SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/27/2023This 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 NUMBERM016This 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 NAMEFirst Nation GroupName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALUMINUM SULFATE TETRADECAHYDRATE; CALCIUM ACETATE MONOHYDRATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH1347; 952 
ACTIVE INGRED UNITmg/2299mg; mg/2299mg 
PHARM CLASSESBlood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA] 

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

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