diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
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 72789-317
Product ID 72789-317_4bbc599b-b951-6949-e063-6394a90ad9fc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2022-04-14
Marketing End 2028-02-29

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 72789317
Hyphenated Format 72789-317

Supplemental Identifiers

RxCUI
1049909
UPC
0372789317304
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 hydrochloride (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-10)
  • 12 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-12)
  • 15 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-15)
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-20)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-30)
source: ndc

Packages (5)

72789-317-10 10 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-10) 72789-317-12 12 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-12) 72789-317-15 15 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-15) 72789-317-20 20 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-20) 72789-317-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-30)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Diphenhydramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4bbc599b-b951-6949-e063-6394a90ad9fc", "openfda": {"upc": ["0372789317304"], "unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["879a7804-f3d4-4a3d-bc92-b473499d6c95"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-10)", "package_ndc": "72789-317-10", "marketing_end_date": "20280229", "marketing_start_date": "20230405"}, {"sample": false, "description": "12 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-12)", "package_ndc": "72789-317-12", "marketing_end_date": "20280229", "marketing_start_date": "20230405"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-15)", "package_ndc": "72789-317-15", "marketing_end_date": "20280229", "marketing_start_date": "20230405"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-20)", "package_ndc": "72789-317-20", "marketing_end_date": "20280229", "marketing_start_date": "20230405"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-30)", "package_ndc": "72789-317-30", "marketing_end_date": "20280229", "marketing_start_date": "20230405"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "72789-317_4bbc599b-b951-6949-e063-6394a90ad9fc", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "72789-317", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20280229", "marketing_start_date": "20220414"}