diphenhydramine hcl oral solution

Generic: diphenhydramine hcl oral

Labeler: everpharm llc
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
Labeler everpharm llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Everpharm LLC

Identifiers & Regulatory

Product NDC 84415-012
Product ID 84415-012_2bd97cb8-2b08-aa8d-e063-6394a90ad19d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-01-16

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 84415012
Hyphenated Format 84415-012

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

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-012-01) / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (1)

84415-012-01 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-012-01) / 5 mL in 1 CUP, UNIT-DOSE

Ingredients (1)

diphenhydramine hydrochloride (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": "2bd97cb8-2b08-aa8d-e063-6394a90ad19d", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["d7aaf874-69ac-49cf-93be-6d4a38b9a557"], "manufacturer_name": ["Everpharm LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-012-01)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "84415-012-01", "marketing_start_date": "20250116"}], "brand_name": "Diphenhydramine HCl Oral Solution", "product_id": "84415-012_2bd97cb8-2b08-aa8d-e063-6394a90ad19d", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "84415-012", "generic_name": "Diphenhydramine HCl Oral", "labeler_name": "Everpharm LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl Oral Solution", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250116", "listing_expiration_date": "20261231"}