diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: leader/ cardinal health 110, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler leader/ cardinal health 110, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
LEADER/ Cardinal Health 110, Inc.

Identifiers & Regulatory

Product NDC 70000-0598
Product ID 70000-0598_4b434677-8323-4529-e063-6294a90a1616
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2022-07-07
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 700000598
Hyphenated Format 70000-0598

Supplemental Identifiers

RxCUI
1049909
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 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
  • 2 BLISTER PACK in 1 CARTON (70000-0598-1) / 12 CAPSULE in 1 BLISTER PACK
  • 100 CAPSULE in 1 BOTTLE (70000-0598-2)
source: ndc

Packages (2)

70000-0598-1 2 BLISTER PACK in 1 CARTON (70000-0598-1) / 12 CAPSULE in 1 BLISTER PACK 70000-0598-2 100 CAPSULE in 1 BOTTLE (70000-0598-2)

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": "4b434677-8323-4529-e063-6294a90a1616", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["e33cbd1d-1848-145a-e053-2995a90aeb50"], "manufacturer_name": ["LEADER/ Cardinal Health 110, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (70000-0598-1)  / 12 CAPSULE in 1 BLISTER PACK", "package_ndc": "70000-0598-1", "marketing_end_date": "20280131", "marketing_start_date": "20220707"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70000-0598-2)", "package_ndc": "70000-0598-2", "marketing_end_date": "20280229", "marketing_start_date": "20220707"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "70000-0598_4b434677-8323-4529-e063-6294a90a1616", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70000-0598", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "LEADER/ Cardinal Health 110, 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": "20220707"}