diphenhydramine hcl

Generic: diphenhydramine hcl

Labeler: pd-rx 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 pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-479
Product ID 55289-479_30c8d0aa-5859-b584-e063-6394a90ac88e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2016-02-01

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 55289479
Hyphenated Format 55289-479

Supplemental Identifiers

RxCUI
1049909
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 M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-10)
  • 12 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-12)
  • 15 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-15)
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-20)
  • 24 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-24)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-30)
source: ndc

Packages (6)

55289-479-10 10 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-10) 55289-479-12 12 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-12) 55289-479-15 15 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-15) 55289-479-20 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-20) 55289-479-24 24 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-24) 55289-479-30 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-30)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "30c8d0aa-5859-b584-e063-6394a90ac88e", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["1ee41c86-6767-43ca-a5bb-fc685fa662cd"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-10)", "package_ndc": "55289-479-10", "marketing_start_date": "20210327"}, {"sample": false, "description": "12 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-12)", "package_ndc": "55289-479-12", "marketing_start_date": "20210327"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-15)", "package_ndc": "55289-479-15", "marketing_start_date": "20210327"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-20)", "package_ndc": "55289-479-20", "marketing_start_date": "20210327"}, {"sample": false, "description": "24 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-24)", "package_ndc": "55289-479-24", "marketing_start_date": "20210327"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-30)", "package_ndc": "55289-479-30", "marketing_start_date": "20180711"}], "brand_name": "Diphenhydramine HCl", "product_id": "55289-479_30c8d0aa-5859-b584-e063-6394a90ac88e", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "55289-479", "generic_name": "Diphenhydramine HCl", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160201", "listing_expiration_date": "20261231"}