nighttime sleep aid

Generic: diphenhydramine hydrochloride

Labeler: shield pharmaceuticals corp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime sleep aid
Generic Name diphenhydramine hydrochloride
Labeler shield pharmaceuticals corp
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
Shield Pharmaceuticals Corp

Identifiers & Regulatory

Product NDC 83059-0122
Product ID 83059-0122_453c8cfa-4363-8b3c-e063-6294a90a5563
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2025-12-05

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 830590122
Hyphenated Format 83059-0122

Supplemental Identifiers

RxCUI
1020477
UPC
0611419406378
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 hydrochloride (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • PRINCIPAL DISPLAY PANEL Compare to the active ingredient in Unisom® SleepGels Sleep-Aid Diphenhydramine HCI Softgels, 50 mg Label Label-Front Label-Back
source: label

Packages (0)

No package records.

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": "453c8cfa-4363-8b3c-e063-6294a90a5563", "openfda": {"upc": ["0611419406378"], "unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["97eb3e4d-06b7-49ed-909b-95b523dcce41"], "manufacturer_name": ["Shield Pharmaceuticals Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Nighttime Sleep Aid", "product_id": "83059-0122_453c8cfa-4363-8b3c-e063-6294a90a5563", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "83059-0122", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Shield Pharmaceuticals Corp", "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": "20251205", "listing_expiration_date": "20261231"}