diphenhydramine hcl oral solution

Generic: diphenhydramine hcl oral solution

Labeler: kesin pharma corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hcl oral solution
Generic Name diphenhydramine hcl oral solution
Labeler kesin pharma corporation
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hcl 12.5 mg/5mL

Manufacturer
Kesin Pharma Corporation

Identifiers & Regulatory

Product NDC 81033-029
Product ID 81033-029_2f871005-de4e-8b2a-e063-6394a90aa43a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-03-04

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 81033029
Hyphenated Format 81033-029

Supplemental Identifiers

RxCUI
1049906
UNII
TC2D6JAD40

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 diphenhydramine hcl oral solution (source: ndc)
Generic Name diphenhydramine hcl oral solution (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (81033-029-16)
source: ndc

Packages (1)

81033-029-16 473 mL in 1 BOTTLE (81033-029-16)

Ingredients (1)

diphenhydramine hcl (12.5 mg/5mL)

Linked Drug Pages (1)

Diphenhydramine HCl Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f871005-de4e-8b2a-e063-6394a90aa43a", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["2f871005-de4d-8b2a-e063-6394a90aa43a"], "manufacturer_name": ["Kesin Pharma Corporation"]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (81033-029-16)", "package_ndc": "81033-029-16", "marketing_start_date": "20250304"}], "brand_name": "Diphenhydramine HCl Oral Solution", "product_id": "81033-029_2f871005-de4e-8b2a-e063-6394a90aa43a", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "81033-029", "generic_name": "Diphenhydramine HCl Oral Solution", "labeler_name": "Kesin Pharma Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl Oral Solution", "active_ingredients": [{"name": "DIPHENHYDRAMINE HCL", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250304", "listing_expiration_date": "20261231"}