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 69452-427
Product ID 69452-427_44e7a512-282e-a87b-e063-6394a90aebf2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2024-03-21

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 69452427
Hyphenated Format 69452-427

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
  • 32 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-10)
  • 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-17)
  • 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-79)
source: ndc

Packages (3)

69452-427-10 32 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-10) 69452-427-17 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-17) 69452-427-79 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-79)

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": "44e7a512-282e-a87b-e063-6394a90aebf2", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["141b00b7-a283-40ab-e063-6294a90aec77"], "manufacturer_name": ["BIONPHARMA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "32 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-10)", "package_ndc": "69452-427-10", "marketing_start_date": "20240321"}, {"sample": false, "description": "60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-17)", "package_ndc": "69452-427-17", "marketing_start_date": "20240321"}, {"sample": false, "description": "160 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-79)", "package_ndc": "69452-427-79", "marketing_start_date": "20240321"}], "brand_name": "Nighttime Sleep-Aid", "product_id": "69452-427_44e7a512-282e-a87b-e063-6394a90aebf2", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69452-427", "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": "20240321", "listing_expiration_date": "20261231"}