nighttime sleep aid

Generic: diphenhydramine hcl

Labeler: healthlife of usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime sleep aid
Generic Name diphenhydramine hcl
Labeler healthlife of usa llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
HealthLife of USA LLC

Identifiers & Regulatory

Product NDC 69517-004
Product ID 69517-004_3f9bfb90-0d2f-16d1-e063-6394a90ac914
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2025-09-25

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 69517004
Hyphenated Format 69517-004

Supplemental Identifiers

RxCUI
1049630
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
  • 25 mg/1
source: ndc
Packaging
  • 300 TABLET, COATED in 1 BOTTLE (69517-004-03)
  • 600 TABLET, COATED in 1 BOTTLE (69517-004-06)
  • 1000 TABLET, COATED in 1 BOTTLE (69517-004-10)
source: ndc

Packages (3)

69517-004-03 300 TABLET, COATED in 1 BOTTLE (69517-004-03) 69517-004-06 600 TABLET, COATED in 1 BOTTLE (69517-004-06) 69517-004-10 1000 TABLET, COATED in 1 BOTTLE (69517-004-10)

Ingredients (1)

diphenhydramine hydrochloride (25 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": "3f9bfb90-0d2f-16d1-e063-6394a90ac914", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["7e8196ec-6695-40b0-a212-e14e9bb606fa"], "manufacturer_name": ["HealthLife of USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET, COATED in 1 BOTTLE (69517-004-03)", "package_ndc": "69517-004-03", "marketing_start_date": "20250925"}, {"sample": false, "description": "600 TABLET, COATED in 1 BOTTLE (69517-004-06)", "package_ndc": "69517-004-06", "marketing_start_date": "20250925"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (69517-004-10)", "package_ndc": "69517-004-10", "marketing_start_date": "20250925"}], "brand_name": "Nighttime Sleep Aid", "product_id": "69517-004_3f9bfb90-0d2f-16d1-e063-6394a90ac914", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69517-004", "generic_name": "Diphenhydramine HCl", "labeler_name": "HealthLife of USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Sleep Aid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250925", "listing_expiration_date": "20261231"}