diphenhydramine hcl

Generic: diphenhydramine hcl

Labeler: nucare 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 nucare pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3650
Product ID 68071-3650_1e01d28e-91bc-134e-e063-6294a90ad58f
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 680713650
Hyphenated Format 68071-3650

Supplemental Identifiers

RxCUI
1020477
UPC
0368071365047
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
  • 4 CAPSULE in 1 BOTTLE (68071-3650-4)
source: ndc

Packages (1)

68071-3650-4 4 CAPSULE in 1 BOTTLE (68071-3650-4)

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": "1e01d28e-91bc-134e-e063-6294a90ad58f", "openfda": {"upc": ["0368071365047"], "unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["1e01f8b8-ca29-902e-e063-6394a90a4cb8"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "4 CAPSULE in 1 BOTTLE (68071-3650-4)", "package_ndc": "68071-3650-4", "marketing_start_date": "20240724"}], "brand_name": "diphenhydramine hcl", "product_id": "68071-3650_1e01d28e-91bc-134e-e063-6294a90ad58f", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68071-3650", "generic_name": "diphenhydramine hcl", "labeler_name": "NuCare 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"}