sleep aid

Generic: diphenhydramine hcl

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

Drug Facts

Product Profile

Brand Name sleep aid
Generic Name diphenhydramine hcl
Labeler allegiant health
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-431
Product ID 69168-431_8f729339-eda6-456a-bdc5-445eff09ff66
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M011
Listing Expiration 2026-12-31
Marketing Start 2021-09-21

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 69168431
Hyphenated Format 69168-431

Supplemental Identifiers

RxCUI
1049909
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 sleep aid (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M011 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 250 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-431-03)
  • 1 BLISTER PACK in 1 CARTON (69168-431-86) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 96 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-431-96)
source: ndc

Packages (3)

69168-431-03 250 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-431-03) 69168-431-86 1 BLISTER PACK in 1 CARTON (69168-431-86) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 69168-431-96 96 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-431-96)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Sleep Aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8f729339-eda6-456a-bdc5-445eff09ff66", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["9746911a-36bc-45eb-adfd-e96439d7a865"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-431-03)", "package_ndc": "69168-431-03", "marketing_start_date": "20230430"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69168-431-86)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "69168-431-86", "marketing_start_date": "20210921"}, {"sample": false, "description": "96 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-431-96)", "package_ndc": "69168-431-96", "marketing_start_date": "20210921"}], "brand_name": "Sleep Aid", "product_id": "69168-431_8f729339-eda6-456a-bdc5-445eff09ff66", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69168-431", "generic_name": "Diphenhydramine HCl", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sleep Aid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M011", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210921", "listing_expiration_date": "20261231"}