Home NDC 69968-0459 Benadryl Extra Strength Itch Relief
Product NDC 69968-0459
11-digit product format 699680459
Labeler code 69968
Product ID 69968-0459_399004db-8df3-c030-e063-6294a90a260b
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE and Zinc Acetate
Dosage form SOLUTION
Route TOPICAL
Labeler Kenvue Brands LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-01
Substance ZINC ACETATE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 1; 20 mg/mL; mg/mL
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 Benadryl Extra Strength Itch Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC ACETATE 1 mg/mL DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FM5526K07A Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1294589 Internal RxNorm lookup 1294591 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 69968-0459-1 Benadryl Extra Strength Itch Relief 1 in 1 CARTON SOLUTION 1 8 69968-0459-1 Benadryl Extra Strength Itch Relief 14 mL in 1 APPLICATOR SOLUTION 14 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0459 BENADRYL EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SOLUTION [KENVUE BRANDS LLC] 7 Current NDC, Legacy NDC, 2 package rows 20241103_309d9be0-e367-429a-a1fa-ab7855477c8a.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 69968-0459-1 69968045901 1 APPLICATOR in 1 CARTON (69968-0459-1) / 14 mL in 1 APPLICATOR 1 applicator 2019-06-01 0000-00-00 No No Current