sominex

Generic: diphenhydramine hydrochloride

Labeler: medtech products inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sominex
Generic Name diphenhydramine hydrochloride
Labeler medtech products inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Medtech Products Inc.

Identifiers & Regulatory

Product NDC 63029-554
Product ID 63029-554_322a3f7f-6a0f-43b9-9819-9ec52e856404
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2012-06-01

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 63029554
Hyphenated Format 63029-554

Supplemental Identifiers

RxCUI
1049630 1086986
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 sominex (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 9 BLISTER PACK in 1 BOX (63029-554-01) / 8 TABLET, FILM COATED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 BOX (63029-554-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 BOX (63029-554-32) / 8 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

63029-554-01 9 BLISTER PACK in 1 BOX (63029-554-01) / 8 TABLET, FILM COATED in 1 BLISTER PACK 63029-554-16 2 BLISTER PACK in 1 BOX (63029-554-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK 63029-554-32 4 BLISTER PACK in 1 BOX (63029-554-32) / 8 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Sominex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "322a3f7f-6a0f-43b9-9819-9ec52e856404", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049630", "1086986"], "spl_set_id": ["f7858ecf-8498-4465-85d8-3e7814737573"], "manufacturer_name": ["Medtech Products Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "9 BLISTER PACK in 1 BOX (63029-554-01)  / 8 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "63029-554-01", "marketing_start_date": "20120601"}, {"sample": false, "description": "2 BLISTER PACK in 1 BOX (63029-554-16)  / 8 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "63029-554-16", "marketing_start_date": "20120601"}, {"sample": false, "description": "4 BLISTER PACK in 1 BOX (63029-554-32)  / 8 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "63029-554-32", "marketing_start_date": "20120601"}], "brand_name": "Sominex", "product_id": "63029-554_322a3f7f-6a0f-43b9-9819-9ec52e856404", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "63029-554", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "Medtech Products Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sominex", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120601", "listing_expiration_date": "20261231"}