nighttime sleep aid

Generic: diphenhydramine hcl

Labeler: topco associates 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 topco associates llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/30mL

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 76162-200
Product ID 76162-200_11f6f7be-59a7-4329-952f-4c2a1e25751d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2023-01-11

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 76162200
Hyphenated Format 76162-200

Supplemental Identifiers

RxCUI
1248354
UPC
0036800375796
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/30mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (76162-200-45)
source: ndc

Packages (1)

76162-200-45 177 mL in 1 BOTTLE, PLASTIC (76162-200-45)

Ingredients (1)

diphenhydramine hydrochloride (50 mg/30mL)

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": "11f6f7be-59a7-4329-952f-4c2a1e25751d", "openfda": {"upc": ["0036800375796"], "unii": ["TC2D6JAD40"], "rxcui": ["1248354"], "spl_set_id": ["9558cc42-d27d-42af-b0a7-44cad025165d"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (76162-200-45)", "package_ndc": "76162-200-45", "marketing_start_date": "20230111"}], "brand_name": "Nighttime Sleep Aid", "product_id": "76162-200_11f6f7be-59a7-4329-952f-4c2a1e25751d", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "76162-200", "generic_name": "Diphenhydramine HCl", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Sleep Aid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/30mL"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230111", "listing_expiration_date": "20261231"}