Home NDC 76168-065 Nightime Sleep Aid
Product NDC 76168-065
11-digit product format 761680065
Labeler code 76168
Product ID 76168-065_6cbc010f-0449-cb45-e053-2a91aa0a1ec6
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Velocity Pharma
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-03-31
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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Nightime Sleep Aid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 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 1020477 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 76168-065-37 Nightime Sleep Aid 16 in 1 BOTTLE CAPSULE, LIQUID FILLED 16 3 76168-065-37 Nightime Sleep Aid 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA] 1 POLYETHYLENE GLYCOL 1000 INACTIVE INGREDIENT U076Q6Q621 NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA] 1 POLYVINYL ACETATE PHTHALATE INACTIVE INGREDIENT 58QVG85GW3 NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76168-065 NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [VELOCITY PHARMA] 3 Current NDC, Legacy NDC, 2 package rows 20180521_9c44e54f-d8bc-4451-8382-40d2e8e03b42.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 1 of 1 · 1 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 76168-065-37 76168006537 16 CARTON in 1 BOTTLE (76168-065-37) / 1 CAPSULE, LIQUID FILLED in 1 CARTON 16 carton 2014-03-31 0000-00-00 No No Current