diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: humanwell puracap pharmaceutical (wuhan), ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler humanwell puracap pharmaceutical (wuhan), ltd.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Identifiers & Regulatory

Product NDC 53345-005
Product ID 53345-005_2752e252-dcaf-d8e5-e063-6394a90a2a4a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2013-04-15

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 53345005
Hyphenated Format 53345-005

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 M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1 BAG in 1 BOX (53345-005-01) / 12000 CAPSULE, LIQUID FILLED in 1 BAG
  • 80 BOTTLE, PLASTIC in 1 BOX (53345-005-02) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

53345-005-01 1 BAG in 1 BOX (53345-005-01) / 12000 CAPSULE, LIQUID FILLED in 1 BAG 53345-005-02 80 BOTTLE, PLASTIC in 1 BOX (53345-005-02) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Ingredients (1)

diphenhydramine hydrochloride (50 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": "2752e252-dcaf-d8e5-e063-6394a90a2a4a", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["f8de6605-4a0a-492d-beb5-f414ce8bfb0e"], "manufacturer_name": ["Humanwell PuraCap Pharmaceutical (Wuhan), Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 BOX (53345-005-01)  / 12000 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "53345-005-01", "marketing_start_date": "20130415"}, {"sample": false, "description": "80 BOTTLE, PLASTIC in 1 BOX (53345-005-02)  / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "53345-005-02", "marketing_start_date": "20130415"}], "brand_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "product_id": "53345-005_2752e252-dcaf-d8e5-e063-6394a90a2a4a", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "53345-005", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DIPHENHYDRAMINE HYDROCHLORIDE", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130415", "listing_expiration_date": "20261231"}