nighttime sleep aid

Generic: doxylamine succinate

Labeler: amerisource bergen
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime sleep aid
Generic Name doxylamine succinate
Labeler amerisource bergen
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxylamine succinate 25 mg/1

Manufacturer
Amerisource Bergen

Identifiers & Regulatory

Product NDC 46122-788
Product ID 46122-788_2ed3591a-fd5f-496e-b40d-0261be247ae1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA040564
Listing Expiration 2026-12-31
Marketing Start 2024-06-07

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46122788
Hyphenated Format 46122-788

Supplemental Identifiers

RxCUI
1101446
UPC
0346122788151
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 nighttime 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
  • 2 BLISTER PACK in 1 CARTON (46122-788-15) / 16 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

46122-788-15 2 BLISTER PACK in 1 CARTON (46122-788-15) / 16 TABLET in 1 BLISTER PACK

Ingredients (1)

doxylamine succinate (25 mg/1)

Linked Drug Pages (1)

Nighttime Sleep Aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2ed3591a-fd5f-496e-b40d-0261be247ae1", "openfda": {"upc": ["0346122788151"], "unii": ["V9BI9B5YI2"], "rxcui": ["1101446"], "spl_set_id": ["ea842bc4-9788-49a9-a7e1-d6e3dd61056a"], "manufacturer_name": ["Amerisource Bergen"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (46122-788-15)  / 16 TABLET in 1 BLISTER PACK", "package_ndc": "46122-788-15", "marketing_start_date": "20240607"}], "brand_name": "Nighttime Sleep Aid", "product_id": "46122-788_2ed3591a-fd5f-496e-b40d-0261be247ae1", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "46122-788", "generic_name": "Doxylamine Succinate", "labeler_name": "Amerisource Bergen", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Sleep Aid", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "25 mg/1"}], "application_number": "ANDA040564", "marketing_category": "ANDA", "marketing_start_date": "20240607", "listing_expiration_date": "20261231"}