Home NDC 68094-018 Diphenhydramine Hydrochloride
Product NDC 68094-018
11-digit product format 680940018
Labeler code 68094
Product ID 68094-018_315b150d-b34d-422c-b3c4-287dd908df8f
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Precision Dose, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-15
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 Diphenhydramine Hydrochloride
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68094-018-59 Diphenhydramine Hydrochloride 10 in 1 BLISTER PACK TABLET 10 5 68094-018-61 Diphenhydramine Hydrochloride 10 in 1 CARTON TABLET 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68094-018 DIPHENHYDRAMINE HYDROCHLORIDE TABLET [PRECISION DOSE, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250309_4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4.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 74 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 68094-018-59 68094001859 10 in 1 BLISTER PACK Historical 68094-018-61 68094001861 10 BLISTER PACK in 1 CARTON (68094-018-61) / 10 TABLET in 1 BLISTER PACK (68094-018-59) 10 blister pack 2019-07-15 0000-00-00 No No Current