stool softener laxative

Generic: docusate sodium

Labeler: top care (topco associates llc)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name stool softener laxative
Generic Name docusate sodium
Labeler top care (topco associates llc)
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

docusate sodium 100 mg/1

Manufacturer
TOP CARE (Topco Associates LLC)

Identifiers & Regulatory

Product NDC 36800-638
Product ID 36800-638_9fc25696-b92e-4f93-b5d1-9bc08177e9fb
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M007
Listing Expiration 2027-12-31
Marketing Start 2021-02-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800638
Hyphenated Format 36800-638

Supplemental Identifiers

RxCUI
1115005
UPC
0036800084629
UNII
F05Q2T2JA0

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 stool softener laxative (source: ndc)
Generic Name docusate sodium (source: ndc)
Application Number M007 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (36800-638-10) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
  • 250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (36800-638-25)
  • 1 BOTTLE, PLASTIC in 1 BOX (36800-638-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

36800-638-10 1 BOTTLE, PLASTIC in 1 BOX (36800-638-10) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 36800-638-25 250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (36800-638-25) 36800-638-60 1 BOTTLE, PLASTIC in 1 BOX (36800-638-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Ingredients (1)

docusate sodium (100 mg/1)

Linked Drug Pages (1)

Stool Softener Laxative ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9fc25696-b92e-4f93-b5d1-9bc08177e9fb", "openfda": {"upc": ["0036800084629"], "unii": ["F05Q2T2JA0"], "rxcui": ["1115005"], "spl_set_id": ["44fe6ce0-5fed-418f-8a6a-d6132e288328"], "manufacturer_name": ["TOP CARE (Topco Associates LLC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (36800-638-10)  / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "36800-638-10", "marketing_start_date": "20210205"}, {"sample": false, "description": "250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (36800-638-25)", "package_ndc": "36800-638-25", "marketing_start_date": "20210205"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (36800-638-60)  / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC", "package_ndc": "36800-638-60", "marketing_start_date": "20210205"}], "brand_name": "Stool Softener Laxative", "product_id": "36800-638_9fc25696-b92e-4f93-b5d1-9bc08177e9fb", "dosage_form": "CAPSULE, LIQUID FILLED", "product_ndc": "36800-638", "generic_name": "DOCUSATE SODIUM", "labeler_name": "TOP CARE (Topco Associates LLC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Stool Softener Laxative", "active_ingredients": [{"name": "DOCUSATE SODIUM", "strength": "100 mg/1"}], "application_number": "M007", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210205", "listing_expiration_date": "20271231"}