Home NDC 52000-071 Extra Strength
Product NDC 52000-071
11-digit product format 520000071
Labeler code 52000
Product ID 52000-071_1853be3d-62de-dc6b-e063-6394a90aad99
Type HUMAN OTC DRUG
Nonproprietary name Itch Stopping Cream
Dosage form CREAM
Route TOPICAL
Labeler Universal Distribution Centre LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-21
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength 20; 1 mg/g; mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Extra Strength
Brand name suffix Itch Stopping
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/g ZINC ACETATE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup FM5526K07A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1087026 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52000-071-03 Extra StrengthItch Stopping 35.4 g in 1 TUBE CREAM 35.4 3 52000-071-04 Extra StrengthItch Stopping 1 in 1 CARTON CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52000-071 EXTRA STRENGTH ITCH STOPPING (ITCH STOPPING CREAM) CREAM [UNIVERSAL DISTRIBUTION CENTRE LLC] 3 Current NDC, Legacy NDC, 2 package rows 20240515_b9a42aa3-1903-76f0-e053-2a95a90a51d1.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 51 of 68 · 1,350 matching rows.
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 52000-071-02 52000007102 1 TUBE in 1 CARTON (52000-071-02) > 35.4 g in 1 TUBE (52000-071-01) 1 tube 2021-01-21 0000-00-00 No No Current 52000-071-03 52000007103 35.4 g in 1 TUBE 35.4 g Historical 52000-071-04 52000007104 1 TUBE in 1 CARTON (52000-071-04) / 35.4 g in 1 TUBE (52000-071-03) 1 tube 2021-01-21 No No Current