nighttime sleep-aid non-habit forming

Generic: diphenhydramine hci

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

Drug Facts

Product Profile

Brand Name nighttime sleep-aid non-habit forming
Generic Name diphenhydramine hci
Labeler aptapharma inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/30mL

Manufacturer
AptaPharma Inc.

Identifiers & Regulatory

Product NDC 76281-522
Product ID 76281-522_f1654da1-64f7-4c2b-9201-3a7af430ba37
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2018-01-01

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 76281522
Hyphenated Format 76281-522

Supplemental Identifiers

RxCUI
1248354
UPC
0376281522242 0376281522259
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 nighttime sleep-aid non-habit forming (source: ndc)
Generic Name diphenhydramine hci (source: ndc)
Application Number M017 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/30mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (76281-522-24)
  • 177 mL in 1 BOTTLE (76281-522-25)
  • 354 mL in 1 BOTTLE (76281-522-28)
source: ndc

Packages (3)

76281-522-24 118 mL in 1 BOTTLE (76281-522-24) 76281-522-25 177 mL in 1 BOTTLE (76281-522-25) 76281-522-28 354 mL in 1 BOTTLE (76281-522-28)

Ingredients (1)

diphenhydramine hydrochloride (50 mg/30mL)

Linked Drug Pages (1)

Nighttime Sleep-Aid Non-Habit Forming ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f1654da1-64f7-4c2b-9201-3a7af430ba37", "openfda": {"upc": ["0376281522242", "0376281522259"], "unii": ["TC2D6JAD40"], "rxcui": ["1248354"], "spl_set_id": ["ed0ba7aa-e794-43da-b576-6b9945bf7477"], "manufacturer_name": ["AptaPharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (76281-522-24)", "package_ndc": "76281-522-24", "marketing_start_date": "20180101"}, {"sample": false, "description": "177 mL in 1 BOTTLE (76281-522-25)", "package_ndc": "76281-522-25", "marketing_start_date": "20180101"}, {"sample": false, "description": "354 mL in 1 BOTTLE (76281-522-28)", "package_ndc": "76281-522-28", "marketing_start_date": "20180101"}], "brand_name": "Nighttime Sleep-Aid Non-Habit Forming", "product_id": "76281-522_f1654da1-64f7-4c2b-9201-3a7af430ba37", "dosage_form": "LIQUID", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "76281-522", "generic_name": "Diphenhydramine HCI", "labeler_name": "AptaPharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Sleep-Aid", "brand_name_suffix": "Non-Habit Forming", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/30mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180101", "listing_expiration_date": "20261231"}