sleep aid

Generic: doxylamine succinate

Labeler: cvs woonsocket prescription center, incorporated
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sleep aid
Generic Name doxylamine succinate
Labeler cvs woonsocket prescription center, incorporated
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxylamine succinate 25 mg/1

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-368
Product ID 51316-368_36d83207-9c02-4d9b-aa06-315941b4889a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA040564
Listing Expiration 2026-12-31
Marketing Start 2025-06-25

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316368
Hyphenated Format 51316-368

Supplemental Identifiers

RxCUI
1101446
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 (51316-368-22) / 16 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

51316-368-22 3 BLISTER PACK in 1 CARTON (51316-368-22) / 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": "36d83207-9c02-4d9b-aa06-315941b4889a", "openfda": {"unii": ["V9BI9B5YI2"], "rxcui": ["1101446"], "spl_set_id": ["6d6e47df-a965-4813-8414-9841ed2f9e0c"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (51316-368-22)  / 16 TABLET in 1 BLISTER PACK", "package_ndc": "51316-368-22", "marketing_start_date": "20250625"}], "brand_name": "Sleep Aid", "product_id": "51316-368_36d83207-9c02-4d9b-aa06-315941b4889a", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "51316-368", "generic_name": "Doxylamine succinate", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "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": "20250625", "listing_expiration_date": "20261231"}