Home NDC 71101-014 TheraCare 2% Diphenhydramine Anti-Itch Cream
Product NDC 71101-014
11-digit product format 711010014
Labeler code 71101
Product ID 71101-014_4085ade5-ebd1-ed55-e063-6394a90a82cf
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride and Zinc Acetate
Dosage form CREAM
Route TOPICAL
Labeler Veridian Healthcare
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-01
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 TheraCare 2% Diphenhydramine Anti-Itch Cream
Listing expiration 2027-12-31 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 71101-014-01 TheraCare 2% Diphenhydramine Anti-Itch Cream 35.4 g in 1 TUBE CREAM 35.4 1 71101-014-01 TheraCare 2% Diphenhydramine Anti-Itch Cream 1 in 1 CARTON CREAM 1 1
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 Sample Exclude flag Status 71101-014-01 71101001401 1 TUBE in 1 CARTON (71101-014-01) / 35.4 g in 1 TUBE 1 tube 2025-10-01 No No Current