52985-900 NDC - ALCOHOL WIPES (ETHYL ALCOHOL)

Drug Information

Product NDC: 52985-900

Proprietary Name: alcohol wipes

Non Proprietary Name: Ethyl Alcohol

Active Ingredient(s):
  • 75 mL/100mL ALCOHOL


Administration Route(s): TOPICAL

Dosage Form(s): CLOTH

Labeler Information

Labeler Name: Anhui Oasis Disinfection Products Co., Ltd
Product Type: HUMAN OTC DRUG
FDA Application Number: part333E
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:6/18/2020

Package Information

No. Package Code Package Description Billing Unit
152985-900-011000 BAG in 1 CARTON (52985-900-01) / 1 POUCH in 1 BAG / 4.86 mL in 1 POUCH
252985-900-02200 BAG in 1 CARTON (52985-900-02) / 10 POUCH in 1 BAG / 48.6 mL in 1 POUCH
352985-900-03100 BOX in 1 CARTON (52985-900-03) / 30 POUCH in 1 BOX / 145.8 mL in 1 POUCH
452985-900-0450 BAG in 1 CARTON (52985-900-04) / 40 POUCH in 1 BAG / 194.4 mL in 1 POUCH
552985-900-0540 BAG in 1 CARTON (52985-900-05) / 50 POUCH in 1 BAG / 243 mL in 1 POUCH
652985-900-0640 BAG in 1 CARTON (52985-900-06) / 60 POUCH in 1 BAG / 291.6 mL in 1 POUCH
752985-900-0730 BAG in 1 CARTON (52985-900-07) / 80 POUCH in 1 BAG / 388.8 mL in 1 POUCH
852985-900-0820 BAG in 1 CARTON (52985-900-08) / 100 POUCH in 1 BAG / 486 mL in 1 POUCH
952985-900-0920 BAG in 1 CARTON (52985-900-09) / 120 POUCH in 1 BAG / 583.2 mL in 1 POUCH
1052985-900-1010 BOX in 1 CARTON (52985-900-10) / 150 POUCH in 1 BOX / 729 mL in 1 POUCH

NDC Record

Field Name Field Value Definition
PRODUCT NDC52985-900The 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 NAMEalcohol wipesThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEEthyl AlcoholThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECLOTHThe 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 DATE6/18/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct 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 NUMBERpart333EThis 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 NAMEAnhui Oasis Disinfection Products Co., LtdName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALCOHOLAn 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 STRENGTH75 
ACTIVE INGRED UNITmL/100mL 

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This page was last updated on: 2/1/2023