Home NDC 71205-521 Benadryl
Product NDC 71205-521
11-digit product format 712050521
Labeler code 71205
Product ID 71205-521_e9c2a959-7772-43f4-a097-535c75b917bd
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-09-01
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes 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 Benadryl
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1049630 Internal RxNorm lookup 1049632 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 71205-521-06 Benadryl 2 in 1 POUCH TABLET, FILM COATED 2 2 71205-521-06 Benadryl 3 in 1 BAG TABLET, FILM COATED 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-521 BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP] 2 Current NDC, Legacy NDC, 2 package rows 20231220_b1c849e5-8003-4fd3-811d-6a927523e353.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 73 of 177 · 3,534 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 71205-521-06 71205052106 3 POUCH in 1 BAG (71205-521-06) / 2 TABLET, FILM COATED in 1 POUCH 3 pouch 2021-01-01 0000-00-00 No No Current