berkley and jensen sleep aid

Generic: doxylamine succinate

Labeler: bjwc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name berkley and jensen sleep aid
Generic Name doxylamine succinate
Labeler bjwc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

doxylamine succinate 25 mg/1

Manufacturer
BJWC

Identifiers & Regulatory

Product NDC 68391-441
Product ID 68391-441_6aed4ba1-211a-4e76-bc4c-0ca3a57fb66a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA040167
Listing Expiration 2026-12-31
Marketing Start 2018-08-06

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68391441
Hyphenated Format 68391-441

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 berkley and jensen 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
  • 2 BOTTLE in 1 CARTON (68391-441-02) / 96 TABLET in 1 BOTTLE
source: ndc

Packages (1)

68391-441-02 2 BOTTLE in 1 CARTON (68391-441-02) / 96 TABLET in 1 BOTTLE

Ingredients (1)

doxylamine succinate (25 mg/1)

Linked Drug Pages (1)

berkley and jensen sleep aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6aed4ba1-211a-4e76-bc4c-0ca3a57fb66a", "openfda": {"unii": ["V9BI9B5YI2"], "rxcui": ["1101446"], "spl_set_id": ["25f468a9-71d4-40f2-97bb-1c3ff5d4b728"], "manufacturer_name": ["BJWC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (68391-441-02)  / 96 TABLET in 1 BOTTLE", "package_ndc": "68391-441-02", "marketing_start_date": "20180806"}], "brand_name": "berkley and jensen sleep aid", "product_id": "68391-441_6aed4ba1-211a-4e76-bc4c-0ca3a57fb66a", "dosage_form": "TABLET", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "68391-441", "generic_name": "Doxylamine succinate", "labeler_name": "BJWC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "berkley and jensen sleep aid", "active_ingredients": [{"name": "DOXYLAMINE SUCCINATE", "strength": "25 mg/1"}], "application_number": "ANDA040167", "marketing_category": "ANDA", "marketing_start_date": "20180806", "listing_expiration_date": "20261231"}