Home NDC 68016-163 Itch Relief Cream
Product NDC 68016-163
11-digit product format 680160163
Labeler code 68016
Product ID 68016-163_29b74830-5473-c90b-e063-6294a90a4e72
Type HUMAN OTC DRUG
Nonproprietary name Zinc Acetate 0.1%, Diphenhydramine hydrochloride 2%
Dosage form CREAM
Route TOPICAL
Labeler Pharmacy Value Alliance LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-07-19
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength 2; .1 g/100g; g/100g
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 2026-12-31
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 Itch Relief Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100g ZINC ACETATE .1 g/100g
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68016-163-01 Itch Relief Cream 28 g in 1 TUBE CREAM 28 8 68016-163-01 Itch Relief Cream 1 in 1 BOX CREAM 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-163 ITCH RELIEF CREAM (ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%) CREAM [PHARMACY VALUE ALLIANCE LLC] 8 Current NDC, Legacy NDC, 2 package rows 20241222_37fe6d82-adee-4f58-e054-00144ff88e88.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 18 of 153 · 3,057 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 68016-163-01 68016016301 1 TUBE in 1 BOX (68016-163-01) / 28 g in 1 TUBE 1 tube 2016-09-01 0000-00-00 No No Current