Diphenhydramine Hydrochloride 25

Generic: Diphenhydramine Hydrochloride 25

Labeler: Elysium Pharmaceuticals Limited
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Active

Drug Facts

Product Profile

Brand Name Diphenhydramine Hydrochloride 25
Generic Name Diphenhydramine Hydrochloride 25
Labeler Elysium Pharmaceuticals Limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1

Identifiers & Regulatory

Product NDC 14803-912
Product ID 14803-912_48ce63d7-e2c5-b448-e063-6294a90a2e94
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2025-09-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14803912
Hyphenated Format 14803-912

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 25 (source: ndc)
Generic Name Diphenhydramine Hydrochloride 25 (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 72000 CAPSULE in 1 DRUM (14803-912-00)
source: ndc

Packages (1)

14803-912-00 72000 CAPSULE in 1 DRUM (14803-912-00)

Ingredients (1)

DIPHENHYDRAMINE HYDROCHLORIDE (25 mg/1)

Linked Drug Pages (1)

Diphenhydramine Hydrochloride 25 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48ce63d7-e2c5-b448-e063-6294a90a2e94", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["3d55914e-0769-2282-e063-6394a90a3a48"], "manufacturer_name": ["Elysium Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "72000 CAPSULE in 1 DRUM (14803-912-00)", "package_ndc": "14803-912-00", "marketing_start_date": "20251101"}], "brand_name": "Diphenhydramine Hydrochloride 25", "product_id": "14803-912_48ce63d7-e2c5-b448-e063-6294a90a2e94", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "14803-912", "generic_name": "Diphenhydramine Hydrochloride 25", "labeler_name": "Elysium Pharmaceuticals Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine Hydrochloride 25", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250901", "listing_expiration_date": "20271231"}