diphenhydramine hcl

Generic: diphenhydramine hcl

Labeler: belleview biosciences
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hcl
Generic Name diphenhydramine hcl
Labeler belleview biosciences
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Belleview Biosciences

Identifiers & Regulatory

Product NDC 84447-103
Product ID 84447-103_3765beab-e853-b34f-e063-6394a90ac9d5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-07-20

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 84447103
Hyphenated Format 84447-103

Supplemental Identifiers

RxCUI
1049906
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 diphenhydramine hcl (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 200000 mL in 1 DRUM (84447-103-01)
  • 118 mL in 1 BOTTLE, PLASTIC (84447-103-04)
  • 473 mL in 1 BOTTLE, PLASTIC (84447-103-16)
source: ndc

Packages (3)

84447-103-01 200000 mL in 1 DRUM (84447-103-01) 84447-103-04 118 mL in 1 BOTTLE, PLASTIC (84447-103-04) 84447-103-16 473 mL in 1 BOTTLE, PLASTIC (84447-103-16)

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Diphenhydramine HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3765beab-e853-b34f-e063-6394a90ac9d5", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["1db57d86-39f0-f8ca-e063-6394a90a6397"], "manufacturer_name": ["Belleview Biosciences"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200000 mL in 1 DRUM (84447-103-01)", "package_ndc": "84447-103-01", "marketing_start_date": "20240720"}, {"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (84447-103-04)", "package_ndc": "84447-103-04", "marketing_start_date": "20240720"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (84447-103-16)", "package_ndc": "84447-103-16", "marketing_start_date": "20240720"}], "brand_name": "Diphenhydramine HCL", "product_id": "84447-103_3765beab-e853-b34f-e063-6394a90ac9d5", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "84447-103", "generic_name": "Diphenhydramine HCL", "labeler_name": "Belleview Biosciences", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCL", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240720", "listing_expiration_date": "20261231"}