topcare sleep aid

Generic: doxylamine succinate

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare sleep aid
Generic Name doxylamine succinate
Labeler topco associates llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

doxylamine succinate 25 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-603
Product ID 76162-603_9e5b860c-237c-48e6-a2a0-91ab1492bae3
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA040167
Listing Expiration 2026-12-31
Marketing Start 2025-03-26

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162603
Hyphenated Format 76162-603

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 topcare 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
  • 1 BOTTLE in 1 CARTON (76162-603-67) / 48 TABLET, COATED in 1 BOTTLE
source: ndc

Packages (1)

76162-603-67 1 BOTTLE in 1 CARTON (76162-603-67) / 48 TABLET, COATED in 1 BOTTLE

Ingredients (1)

doxylamine succinate (25 mg/1)

Linked Drug Pages (1)

topcare sleep aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9e5b860c-237c-48e6-a2a0-91ab1492bae3", "openfda": {"unii": ["V9BI9B5YI2"], "rxcui": ["1101446"], "spl_set_id": ["c8b24ed8-34a1-4857-8fcb-6e3f9d407903"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (76162-603-67)  / 48 TABLET, COATED in 1 BOTTLE", "package_ndc": "76162-603-67", "marketing_start_date": "20250326"}], "brand_name": "topcare sleep aid", "product_id": "76162-603_9e5b860c-237c-48e6-a2a0-91ab1492bae3", "dosage_form": "TABLET, COATED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "76162-603", "generic_name": "doxylamine succinate", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare sleep aid", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "25 mg/1"}], "application_number": "ANDA040167", "marketing_category": "ANDA", "marketing_start_date": "20250326", "listing_expiration_date": "20261231"}