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 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-720
Product ID 43063-720_414b0d91-61fd-bca0-e063-6294a90a7852
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2009-11-02

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 43063720
Hyphenated Format 43063-720

Supplemental Identifiers

RxCUI
1020477
UPC
9375003720158
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 M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-10)
  • 15 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-15)
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-20)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-30)
  • 40 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-40)
source: ndc

Packages (5)

43063-720-10 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-10) 43063-720-15 15 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-15) 43063-720-20 20 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-20) 43063-720-30 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-30) 43063-720-40 40 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-40)

Ingredients (1)

diphenhydramine hydrochloride (50 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": "414b0d91-61fd-bca0-e063-6294a90a7852", "openfda": {"upc": ["9375003720158"], "unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["09fdb235-f105-4a53-a598-91abeb537404"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-10)", "package_ndc": "43063-720-10", "marketing_start_date": "20230201"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-15)", "package_ndc": "43063-720-15", "marketing_start_date": "20210518"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-20)", "package_ndc": "43063-720-20", "marketing_start_date": "20210405"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-30)", "package_ndc": "43063-720-30", "marketing_start_date": "20210405"}, {"sample": false, "description": "40 CAPSULE in 1 BOTTLE, PLASTIC (43063-720-40)", "package_ndc": "43063-720-40", "marketing_start_date": "20210405"}], "brand_name": "Diphenhydramine HCL", "product_id": "43063-720_414b0d91-61fd-bca0-e063-6294a90a7852", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "43063-720", "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": "50 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20091102", "listing_expiration_date": "20261231"}