Home NDC 0573-0553 PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES
Product NDC 0573-0553
11-digit product format 005730553
Labeler code 0573
Product ID 0573-0553_5190224a-ec77-c801-e063-6294a90a80d8
Type HUMAN OTC DRUG
Nonproprietary name witch hazel
Dosage form CLOTH
Route TOPICAL
Labeler Haleon US Holdings LLC
Application M015
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-03-04
Marketing end 2026-12-31
Substance WITCH HAZEL
Active strength 200 mg/1
NDC exclude flag No
Current FDA listing Yes 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 package package 0573-0553 0573-0553-95 D Discontinued by firm 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 When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Additional Listing Data#
Finished product Yes
Brand name base PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES Active Ingredients# Ingredient, Strength table Ingredient Strength WITCH HAZEL 200 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 101I4J0U34 Rxcui 1544863
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0573-0553-60 PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES 60 in 1 POUCH CLOTH 60 5 0573-0553-95 PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES 3 in 1 CARTON CLOTH 3 5 0573-0553-95 PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES 60 in 1 POUCH CLOTH 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0573-0553 PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES (WITCH HAZEL) CLOTH [HALEON US HOLDINGS LLC] 3 Current NDC, Legacy NDC, 3 package rows 20240303_485437a8-b2e9-4acf-a20e-edb1f08a9cae.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 0573-0553-60 00573055360 60 CLOTH in 1 POUCH (0573-0553-60) 60 cloth 2020-03-04 2026-11-30 No No Current 0573-0553-95 00573055395 3 POUCH in 1 CARTON (0573-0553-95) > 60 CLOTH in 1 POUCH 3 pouch 2020-03-04 0000-00-00 No No Current