Home NDC 51316-835-01 Diphenhydramine Hydrochloride
Product NDC 51316-835
Requested package NDC 51316-835-01
11-digit product format 513160835
Labeler code 51316
Product ID 51316-835_5de60ede-dfb0-aeb8-e063-6294a90acff2
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler CVS Pharmacy, Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-16
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 Diphenhydramine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51316-835-01 Diphenhydramine Hydrochloride 1 in 1 CARTON CAPSULE 1 2 51316-835-01 Diphenhydramine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 2 51316-835-03 Diphenhydramine Hydrochloride 4 in 1 CARTON CAPSULE 4 2 51316-835-03 Diphenhydramine Hydrochloride 12 in 1 BLISTER PACK CAPSULE 12 2 51316-835-07 Diphenhydramine Hydrochloride 365 in 1 BOTTLE CAPSULE 365 2 51316-835-08 Diphenhydramine Hydrochloride 2 in 1 CARTON CAPSULE 2 2 51316-835-08 Diphenhydramine Hydrochloride 12 in 1 BLISTER PACK CAPSULE 12 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-835 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [CVS PHARMACY, INC] 2 Current NDC, 7 package rows 20241208_f4468840-e17c-6888-e053-2995a90a04a0.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 178 · 3,550 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 51316-835-01 51316083501 1 BOTTLE in 1 CARTON (51316-835-01) / 100 CAPSULE in 1 BOTTLE 1 bottle 2022-12-01 2028-03-31 No No Historical