sleep aid

Generic: diphenhydramine hcl 25 mg

Labeler: nuvicare llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sleep aid
Generic Name diphenhydramine hcl 25 mg
Labeler nuvicare llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
NUVICARE LLC

Identifiers & Regulatory

Product NDC 84324-016
Product ID 84324-016_b27e9072-5af6-4a97-82a7-34ee2698fe2e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2024-07-18

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 84324016
Hyphenated Format 84324-016

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 sleep aid (source: ndc)
Generic Name diphenhydramine hcl 25 mg (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 200 TABLET in 1 BOTTLE (84324-016-01)
source: ndc

Packages (1)

84324-016-01 200 TABLET in 1 BOTTLE (84324-016-01)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Sleep Aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b27e9072-5af6-4a97-82a7-34ee2698fe2e", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["85391744-3bf5-428e-a77b-464aa95b3a1a"], "manufacturer_name": ["NUVICARE LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 TABLET in 1 BOTTLE (84324-016-01)", "package_ndc": "84324-016-01", "marketing_start_date": "20240718"}], "brand_name": "Sleep Aid", "product_id": "84324-016_b27e9072-5af6-4a97-82a7-34ee2698fe2e", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "84324-016", "generic_name": "Diphenhydramine HCl 25 mg", "labeler_name": "NUVICARE LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sleep Aid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240718", "listing_expiration_date": "20261231"}