Home NDC 69168-048 Allergy
Product NDC 69168-048
11-digit product format 691680048
Labeler code 69168
Product ID 69168-048_b53853c5-5f00-41ab-8d0d-eb40aba6e67b
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-15
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 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 Allergy
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049630 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# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-048 ALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH] 6 Current NDC, Legacy NDC, 5 package rows 20231109_c2823bad-540f-4662-8dcc-58e9f0d94efb.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 98 of 180 · 3,583 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 69168-048-01 69168004801 100 TABLET in 1 BOTTLE (69168-048-01) 100 tablet 2014-12-15 0000-00-00 No No Current 69168-048-20 69168004820 600 TABLET in 1 BOTTLE (69168-048-20) 600 tablet 2020-03-22 0000-00-00 No No Current 69168-048-93 69168004893 2 BLISTER PACK in 1 BOX (69168-048-93) / 12 TABLET in 1 BLISTER PACK 2 blister pack 2014-12-15 0000-00-00 No No Current 69168-048-98 69168004898 200 TABLET in 1 BOTTLE (69168-048-98) 200 tablet 2022-05-18 0000-00-00 No No Current