bonine faster-acting

Generic: diphenhydramine hcl

Labeler: wellspring pharmaceutical corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name bonine faster-acting
Generic Name diphenhydramine hcl
Labeler wellspring pharmaceutical corporation
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
WellSpring Pharmaceutical Corporation

Identifiers & Regulatory

Product NDC 65197-616
Product ID 65197-616_72ea173f-50b2-448c-8a70-842b19d899fd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M009
Marketing Start 2023-05-01
Marketing End 2026-04-30

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 65197616
Hyphenated Format 65197-616

Supplemental Identifiers

RxCUI
1049630
UPC
0365197296163
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 bonine faster-acting (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 BOX (65197-616-16) / 8 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

65197-616-16 2 BLISTER PACK in 1 BOX (65197-616-16) / 8 TABLET in 1 BLISTER PACK

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

BONINE Faster-Acting ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "72ea173f-50b2-448c-8a70-842b19d899fd", "openfda": {"upc": ["0365197296163"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["2c6f014d-6d46-4f8a-9196-904639dcb899"], "manufacturer_name": ["WellSpring Pharmaceutical Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 BOX (65197-616-16)  / 8 TABLET in 1 BLISTER PACK", "package_ndc": "65197-616-16", "marketing_end_date": "20260430", "marketing_start_date": "20230501"}], "brand_name": "BONINE Faster-Acting", "product_id": "65197-616_72ea173f-50b2-448c-8a70-842b19d899fd", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "65197-616", "generic_name": "Diphenhydramine HCl", "labeler_name": "WellSpring Pharmaceutical Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "BONINE", "brand_name_suffix": "Faster-Acting", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M009", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20260430", "marketing_start_date": "20230501"}