Home NDC 35916-0435 DIPHENHYDRAMINE HYDROCHLORIDE
Product NDC 35916-0435
11-digit product format 359160435
Labeler code 35916
Product ID 35916-0435_5003a7e3-9310-497a-e063-6394a90a31ea
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler SOFTGEL HEALTHCARE PRIVATE LIMITED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-07
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
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 1049909 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 35916-0435-1 DIPHENHYDRAMINE HYDROCHLORIDE 3 in 1 CARTON CAPSULE, LIQUID FILLED 3 6 35916-0435-3 DIPHENHYDRAMINE HYDROCHLORIDE 1000 in 1 BAG CAPSULE, LIQUID FILLED 1000 6 35916-0435-4 DIPHENHYDRAMINE HYDROCHLORIDE 2 in 1 BOX CAPSULE, LIQUID FILLED 2 6 35916-0435-4 DIPHENHYDRAMINE HYDROCHLORIDE 3000 in 1 POUCH CAPSULE, LIQUID FILLED 3000 6 35916-0435-5 DIPHENHYDRAMINE HYDROCHLORIDE 1500 in 1 BAG CAPSULE, LIQUID FILLED 1500 6 35916-0435-5 DIPHENHYDRAMINE HYDROCHLORIDE 2 in 1 BOX CAPSULE, LIQUID FILLED 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35916-0435 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PRIVATE LIMITED] 3 Current NDC, 6 package rows 20240331_0203d919-dc1f-cca0-e063-6394a90aa1aa.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 97 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 35916-0435-1 35916043501 3 CAPSULE, LIQUID FILLED in 1 CARTON (35916-0435-1) 2023-08-07 No No Current 35916-0435-3 35916043503 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0435-3) 2025-04-22 No No Current 35916-0435-4 35916043504 2 POUCH in 1 BOX (35916-0435-4) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH 2 pouch 2025-06-11 No No Current 35916-0435-5 35916043505 2 BAG in 1 BOX (35916-0435-5) / 1500 CAPSULE, LIQUID FILLED in 1 BAG 2 bag 2026-01-24 No No Current