diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: richmond pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler richmond pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
Richmond Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 54738-116
Product ID 54738-116_5cc3bf1b-466c-6a53-e053-2a91aa0abfa6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part341
Listing Expiration 2026-12-31
Marketing Start 2015-05-01

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 54738116
Hyphenated Format 54738-116

Supplemental Identifiers

RxCUI
1020477
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 part341 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (54738-116-01)
  • 1000 CAPSULE in 1 BOTTLE (54738-116-03)
source: ndc

Packages (2)

54738-116-01 100 CAPSULE in 1 BOTTLE (54738-116-01) 54738-116-03 1000 CAPSULE in 1 BOTTLE (54738-116-03)

Ingredients (1)

diphenhydramine hydrochloride (50 mg/1)

Linked Drug Pages (2)

Diphenhydramine Hydrochloride ndc-match (0.9) Diphenhydramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5cc3bf1b-466c-6a53-e053-2a91aa0abfa6", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["ab67121e-2477-47dd-a7ec-114453df3fd4"], "manufacturer_name": ["Richmond Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (54738-116-01)", "package_ndc": "54738-116-01", "marketing_start_date": "20150501"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (54738-116-03)", "package_ndc": "54738-116-03", "marketing_start_date": "20150501"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "54738-116_5cc3bf1b-466c-6a53-e053-2a91aa0abfa6", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "54738-116", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Richmond Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "part341", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20150501", "listing_expiration_date": "20261231"}