Home NDC 54016-020 PURE CARE -ALCOHOL WIPES
Product NDC 54016-020
11-digit product format 540160020
Labeler code 54016
Product ID 54016-020_b61a0cc6-2fba-522f-e053-2a95a90acc2e
Type HUMAN OTC DRUG
Nonproprietary name PURE CARE -ALCOHOL WIPES
Dosage form CLOTH
Route TOPICAL
Labeler Jinhua Huihuang Non-woven Products Co., Ltd.
Application part333E
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-12-10
Marketing end 0000-00-00
Substance ISOPROPYL ALCOHOL
Active strength 75 mL/100mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 54016-020 I Inactivated by FDA 2026-07-31 excluded package package 54016-020 54016-020-12 I Inactivated by FDA 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only. Flammable. Keep away from heat or flame. Do not use on children less than 2 months of age. on open skin wounds When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54016-020-12 PURE CARE -ALCOHOL WIPES 5.5 mL in 1 PATCH CLOTH 5.5 1 54016-020-12 PURE CARE -ALCOHOL WIPES 100 in 1 PACKET CLOTH 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54016-020 PURE CARE -ALCOHOL WIPES CLOTH [JINHUA HUIHUANG NON-WOVEN PRODUCTS CO., LTD.] 1 Legacy NDC, 2 package rows 20201211_b619f275-9db3-eefb-e053-2a95a90aa2df.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54016-020-12 54016002012 100 PATCH in 1 PACKET (54016-020-12) > 5.5 mL in 1 PATCH 100 patch 2020-12-10 0000-00-00 No No Current