sleep aid

Generic: doxylamine succinate

Labeler: walgreen company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sleep aid
Generic Name doxylamine succinate
Labeler walgreen company
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxylamine succinate 25 mg/1

Manufacturer
Walgreen Company

Identifiers & Regulatory

Product NDC 0363-0386
Product ID 0363-0386_d1c23648-ab41-4db2-aaf2-d0f3fabd0aa2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA040564
Listing Expiration 2027-12-31
Marketing Start 2024-04-05

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03630386
Hyphenated Format 0363-0386

Supplemental Identifiers

RxCUI
1101446
UPC
0311917045139
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
  • 1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-12) / 100 TABLET in 1 BOTTLE, PLASTIC
  • 3 BLISTER PACK in 1 CARTON (0363-0386-22) / 16 TABLET in 1 BLISTER PACK
  • 1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-31) / 80 TABLET in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

0363-0386-12 1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-12) / 100 TABLET in 1 BOTTLE, PLASTIC 0363-0386-22 3 BLISTER PACK in 1 CARTON (0363-0386-22) / 16 TABLET in 1 BLISTER PACK 0363-0386-31 1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-31) / 80 TABLET in 1 BOTTLE, PLASTIC

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": "d1c23648-ab41-4db2-aaf2-d0f3fabd0aa2", "openfda": {"upc": ["0311917045139"], "unii": ["V9BI9B5YI2"], "rxcui": ["1101446"], "spl_set_id": ["d812217b-b2f2-4716-92f4-c16bd0768e17"], "manufacturer_name": ["Walgreen Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-12)  / 100 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "0363-0386-12", "marketing_start_date": "20241231"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0363-0386-22)  / 16 TABLET in 1 BLISTER PACK", "package_ndc": "0363-0386-22", "marketing_start_date": "20240405"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-31)  / 80 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "0363-0386-31", "marketing_start_date": "20240405"}], "brand_name": "Sleep Aid", "product_id": "0363-0386_d1c23648-ab41-4db2-aaf2-d0f3fabd0aa2", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "0363-0386", "generic_name": "Doxylamine succinate", "labeler_name": "Walgreen Company", "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": "20240405", "listing_expiration_date": "20271231"}