nighttime sleep-aid

Generic: diphenhydramine hcl

Labeler: guardian drug company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime sleep-aid
Generic Name diphenhydramine hcl
Labeler guardian drug company
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/30mL

Manufacturer
Guardian Drug Company

Identifiers & Regulatory

Product NDC 53041-633
Product ID 53041-633_329d343f-2056-4870-930c-348917bfb2bc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number part338
Listing Expiration 2026-12-31
Marketing Start 2024-01-11

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 53041633
Hyphenated Format 53041-633

Supplemental Identifiers

RxCUI
1248354
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 part338 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/30mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE (53041-633-58)
source: ndc

Packages (1)

53041-633-58 177 mL in 1 BOTTLE (53041-633-58)

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": "329d343f-2056-4870-930c-348917bfb2bc", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1248354"], "spl_set_id": ["329d343f-2056-4870-930c-348917bfb2bc"], "manufacturer_name": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (53041-633-58)", "package_ndc": "53041-633-58", "marketing_start_date": "20240111"}], "brand_name": "Nighttime Sleep-Aid", "product_id": "53041-633_329d343f-2056-4870-930c-348917bfb2bc", "dosage_form": "LIQUID", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "53041-633", "generic_name": "Diphenhydramine HCl", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Sleep-Aid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/30mL"}], "application_number": "part338", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240111", "listing_expiration_date": "20261231"}