Home NDC 51316-221 Diphenhydramine HCl
Product NDC 51316-221
11-digit product format 513160221
Labeler code 51316
Product ID 51316-221_5c9028c4-3131-a0c1-e063-6294a90ad84c
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler CVS Pharmacy, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-31
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 50 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 Diphenhydramine HCl
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51316-221-08 Diphenhydramine HCl 2 in 1 CARTON TABLET, COATED 2 1 51316-221-08 Diphenhydramine HCl 12 in 1 BLISTER PACK TABLET, COATED 12 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-221 DIPHENHYDRAMINE HCL TABLET, COATED [CVS PHARMACY, INC.] 1 Current NDC, 2 package rows 20240208_1059b55b-c218-843f-e063-6294a90af2fe.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 51316-221-08 51316022108 2 BLISTER PACK in 1 CARTON (51316-221-08) / 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2024-01-31 2028-11-30 No No Historical