banophen

Generic: diphenhydramine hcl

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name banophen
Generic Name diphenhydramine hcl
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-5551
Product ID 0904-5551_e0443532-ae16-498a-86f5-c706edb11aa6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 1990-03-02

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 09045551
Hyphenated Format 0904-5551

Supplemental Identifiers

RxCUI
1049630 1092421
UPC
0309045551240
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 banophen (source: ndc)
Generic Name diphenhydramine hcl (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 (0904-5551-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE, PLASTIC in 1 CARTON (0904-5551-59) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

0904-5551-24 2 BLISTER PACK in 1 CARTON (0904-5551-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK 0904-5551-59 1 BOTTLE, PLASTIC in 1 CARTON (0904-5551-59) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Banophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e0443532-ae16-498a-86f5-c706edb11aa6", "openfda": {"upc": ["0309045551240"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630", "1092421"], "spl_set_id": ["69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0904-5551-24)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-5551-24", "marketing_start_date": "19900302"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0904-5551-59)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "0904-5551-59", "marketing_start_date": "19900302"}], "brand_name": "Banophen", "product_id": "0904-5551_e0443532-ae16-498a-86f5-c706edb11aa6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0904-5551", "generic_name": "Diphenhydramine HCl", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Banophen", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19900302", "listing_expiration_date": "20261231"}