sleep-aid

Generic: doxylamine succinate

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sleep-aid
Generic Name doxylamine succinate
Labeler cardinal health 110, llc. dba leader
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxylamine succinate 25 mg/1

Manufacturer
Cardinal Health 110, LLC. DBA Leader

Identifiers & Regulatory

Product NDC 70000-0567
Product ID 70000-0567_8b3b9de1-0b79-4cd4-bba9-aa6b49151594
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA040564
Listing Expiration 2026-12-31
Marketing Start 2020-07-23

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000567
Hyphenated Format 70000-0567

Supplemental Identifiers

RxCUI
1101446
UPC
0096295139891
UNII
V9BI9B5YI2

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 doxylamine succinate (source: ndc)
Application Number ANDA040564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (70000-0567-1) / 16 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

70000-0567-1 3 BLISTER PACK in 1 CARTON (70000-0567-1) / 16 TABLET in 1 BLISTER PACK

Ingredients (1)

doxylamine succinate (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": "8b3b9de1-0b79-4cd4-bba9-aa6b49151594", "openfda": {"upc": ["0096295139891"], "unii": ["V9BI9B5YI2"], "rxcui": ["1101446"], "spl_set_id": ["96e8d6df-e717-4ffc-9502-498024c9665f"], "manufacturer_name": ["Cardinal Health 110, LLC. DBA Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (70000-0567-1)  / 16 TABLET in 1 BLISTER PACK", "package_ndc": "70000-0567-1", "marketing_start_date": "20200723"}], "brand_name": "Sleep-Aid", "product_id": "70000-0567_8b3b9de1-0b79-4cd4-bba9-aa6b49151594", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "70000-0567", "generic_name": "Doxylamine succinate", "labeler_name": "Cardinal Health 110, LLC. DBA Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sleep-Aid", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "25 mg/1"}], "application_number": "ANDA040564", "marketing_category": "ANDA", "marketing_start_date": "20200723", "listing_expiration_date": "20261231"}