careone nighttime sleep aid

Generic: doxylamine succinate

Labeler: american sales company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name careone nighttime sleep aid
Generic Name doxylamine succinate
Labeler american sales company
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxylamine succinate 25 mg/1

Manufacturer
American Sales Company

Identifiers & Regulatory

Product NDC 41520-634
Product ID 41520-634_e2094ba5-90c3-4e4a-91ea-c51ba4a09cb7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA040167
Listing Expiration 2026-12-31
Marketing Start 2016-05-06

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 41520634
Hyphenated Format 41520-634

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 careone nighttime sleep aid (source: ndc)
Generic Name doxylamine succinate (source: ndc)
Application Number ANDA040167 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 32 BLISTER PACK in 1 CARTON (41520-634-64) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

41520-634-64 32 BLISTER PACK in 1 CARTON (41520-634-64) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

doxylamine succinate (25 mg/1)

Linked Drug Pages (1)

CareOne Nighttime Sleep Aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e2094ba5-90c3-4e4a-91ea-c51ba4a09cb7", "openfda": {"unii": ["V9BI9B5YI2"], "rxcui": ["1101446"], "spl_set_id": ["f8bfc874-53be-41e8-b59c-d538825761a8"], "manufacturer_name": ["American Sales Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "32 BLISTER PACK in 1 CARTON (41520-634-64)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "41520-634-64", "marketing_start_date": "20160506"}], "brand_name": "CareOne Nighttime Sleep Aid", "product_id": "41520-634_e2094ba5-90c3-4e4a-91ea-c51ba4a09cb7", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "41520-634", "generic_name": "Doxylamine succinate", "labeler_name": "American Sales Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CareOne Nighttime Sleep Aid", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "25 mg/1"}], "application_number": "ANDA040167", "marketing_category": "ANDA", "marketing_start_date": "20160506", "listing_expiration_date": "20261231"}