nighttime sleep aid

Generic: diphenhydramine hcl 50mg

Labeler: puracap pharmaceutical llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime sleep aid
Generic Name diphenhydramine hcl 50mg
Labeler puracap pharmaceutical llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
PuraCap Pharmaceutical LLC

Identifiers & Regulatory

Product NDC 51013-817
Product ID 51013-817_272a7138-2a98-8e62-e063-6394a90a1af1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2024-11-30

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51013817
Hyphenated Format 51013-817

Supplemental Identifiers

RxCUI
1020477
UPC
0351013817018
UNII
TC2D6JAD40

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nighttime sleep aid (source: ndc)
Generic Name diphenhydramine hcl 50mg (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-817-01)
source: ndc

Packages (1)

51013-817-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-817-01)

Ingredients (1)

diphenhydramine hydrochloride (50 mg/1)

Linked Drug Pages (1)

Nighttime SLEEP AID ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "272a7138-2a98-8e62-e063-6394a90a1af1", "openfda": {"upc": ["0351013817018"], "unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["272a7138-2a97-8e62-e063-6394a90a1af1"], "manufacturer_name": ["PuraCap Pharmaceutical LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-817-01)", "package_ndc": "51013-817-01", "marketing_start_date": "20241130"}], "brand_name": "Nighttime SLEEP AID", "product_id": "51013-817_272a7138-2a98-8e62-e063-6394a90a1af1", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51013-817", "generic_name": "Diphenhydramine HCl 50mg", "labeler_name": "PuraCap Pharmaceutical LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime SLEEP AID", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241130", "listing_expiration_date": "20261231"}