nighttime sleep-aid

Generic: diphenhydramine hcl

Labeler: bionpharma inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime sleep-aid
Generic Name diphenhydramine hcl
Labeler bionpharma inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-322
Product ID 69452-322_0d63c644-46c2-b4c0-e063-6394a90a9dd3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2021-04-27

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 69452322
Hyphenated Format 69452-322

Supplemental Identifiers

RxCUI
1020477
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 (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-322-79)
source: ndc

Packages (1)

69452-322-79 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-322-79)

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": "0d63c644-46c2-b4c0-e063-6394a90a9dd3", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["c0074c77-287e-6c26-e053-2995a90a4d31"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-322-79)", "package_ndc": "69452-322-79", "marketing_start_date": "20210427"}], "brand_name": "nighttime sleep-aid", "product_id": "69452-322_0d63c644-46c2-b4c0-e063-6394a90a9dd3", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69452-322", "generic_name": "Diphenhydramine HCl", "labeler_name": "Bionpharma Inc.", "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": "20210427", "listing_expiration_date": "20261231"}