night time sleep-aid

Generic: diphenhydramine hcl

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name night time sleep-aid
Generic Name diphenhydramine hcl
Labeler advanced rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-383
Product ID 80513-383_38ec4df3-7635-3adf-e063-6394a90a0cec
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Marketing Start 2024-08-01
Marketing End 2027-12-31

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 80513383
Hyphenated Format 80513-383

Supplemental Identifiers

RxCUI
1049630
UPC
0380513000934
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 night time 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
  • 220 TABLET in 1 BOTTLE (80513-383-22)
source: ndc

Packages (1)

80513-383-22 220 TABLET in 1 BOTTLE (80513-383-22)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

NIGHT TIME SLEEP-AID ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "38ec4df3-7635-3adf-e063-6394a90a0cec", "openfda": {"upc": ["0380513000934"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["07c69e63-deb1-4607-9f7f-1cf0cd05cc82"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "220 TABLET in 1 BOTTLE (80513-383-22)", "package_ndc": "80513-383-22", "marketing_end_date": "20271231", "marketing_start_date": "20240801"}], "brand_name": "NIGHT TIME SLEEP-AID", "product_id": "80513-383_38ec4df3-7635-3adf-e063-6394a90a0cec", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "80513-383", "generic_name": "Diphenhydramine HCl", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NIGHT TIME SLEEP-AID", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20271231", "marketing_start_date": "20240801"}