allergy

Generic: diphenhydramine hcl

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name allergy
Generic Name diphenhydramine hcl
Labeler allegiant health
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-048
Product ID 69168-048_b53853c5-5f00-41ab-8d0d-eb40aba6e67b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-12-15

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 69168048
Hyphenated Format 69168-048

Supplemental Identifiers

RxCUI
1049630
UPC
0369168048935
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 allergy (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
  • 100 TABLET in 1 BOTTLE (69168-048-01)
  • 600 TABLET in 1 BOTTLE (69168-048-20)
  • 2 BLISTER PACK in 1 BOX (69168-048-93) / 12 TABLET in 1 BLISTER PACK
  • 200 TABLET in 1 BOTTLE (69168-048-98)
source: ndc

Packages (4)

69168-048-01 100 TABLET in 1 BOTTLE (69168-048-01) 69168-048-20 600 TABLET in 1 BOTTLE (69168-048-20) 69168-048-93 2 BLISTER PACK in 1 BOX (69168-048-93) / 12 TABLET in 1 BLISTER PACK 69168-048-98 200 TABLET in 1 BOTTLE (69168-048-98)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b53853c5-5f00-41ab-8d0d-eb40aba6e67b", "openfda": {"upc": ["0369168048935"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["c2823bad-540f-4662-8dcc-58e9f0d94efb"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69168-048-01)", "package_ndc": "69168-048-01", "marketing_start_date": "20141215"}, {"sample": false, "description": "600 TABLET in 1 BOTTLE (69168-048-20)", "package_ndc": "69168-048-20", "marketing_start_date": "20200322"}, {"sample": false, "description": "2 BLISTER PACK in 1 BOX (69168-048-93)  / 12 TABLET in 1 BLISTER PACK", "package_ndc": "69168-048-93", "marketing_start_date": "20141215"}, {"sample": false, "description": "200 TABLET in 1 BOTTLE (69168-048-98)", "package_ndc": "69168-048-98", "marketing_start_date": "20220518"}], "brand_name": "Allergy", "product_id": "69168-048_b53853c5-5f00-41ab-8d0d-eb40aba6e67b", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69168-048", "generic_name": "Diphenhydramine HCl", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Allergy", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20141215", "listing_expiration_date": "20261231"}