diphenhydramine hcl

Generic: diphenhydramine hcl

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hcl
Generic Name diphenhydramine hcl
Labeler preferred pharmaceuticals inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8274
Product ID 68788-8274_df85442a-6418-418a-bc14-a106564fa779
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 341
Listing Expiration 2026-12-31
Marketing Start 2022-10-14

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 687888274
Hyphenated Format 68788-8274

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 (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number 341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (68788-8274-1)
source: ndc

Packages (1)

68788-8274-1 118 mL in 1 BOTTLE, PLASTIC (68788-8274-1)

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": "df85442a-6418-418a-bc14-a106564fa779", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["d3f769d7-3cbb-4469-bff8-2015619ee115"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (68788-8274-1)", "package_ndc": "68788-8274-1", "marketing_start_date": "20221014"}], "brand_name": "Diphenhydramine HCl", "product_id": "68788-8274_df85442a-6418-418a-bc14-a106564fa779", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68788-8274", "generic_name": "Diphenhydramine HCl", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "341", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20221014", "listing_expiration_date": "20261231"}