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 69452-451
Product ID 69452-451_44e7d174-6100-5d9b-e063-6294a90aa6d5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2024-10-01

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 69452451
Hyphenated Format 69452-451

Supplemental Identifiers

RxCUI
1020477
UPC
0369452451229
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
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-451-22)
source: ndc

Packages (1)

69452-451-22 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-451-22)

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": "44e7d174-6100-5d9b-e063-6294a90aa6d5", "openfda": {"upc": ["0369452451229"], "unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["1f74e760-9ba9-ac47-e063-6394a90acdff"], "manufacturer_name": ["BIONPHARMA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-451-22)", "package_ndc": "69452-451-22", "marketing_start_date": "20241001"}], "brand_name": "Nighttime Sleep-Aid", "product_id": "69452-451_44e7d174-6100-5d9b-e063-6294a90aa6d5", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69452-451", "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": "20241001", "listing_expiration_date": "20261231"}