Stool Softener Laxative

Product NDC
36800-638
11-digit product format
368000638
Labeler code
36800
Product ID
36800-638_9fc25696-b92e-4f93-b5d1-9bc08177e9fb
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-05
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1115005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-638-10Stool Softener Laxative1 in 1 BOXCAPSULE, LIQUID FILLED16
36800-638-10Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1006
36800-638-25Stool Softener Laxative250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2506
36800-638-60Stool Softener Laxative1 in 1 BOXCAPSULE, LIQUID FILLED16
36800-638-60Stool Softener Laxative60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-638STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]5Current NDC, Legacy NDC, 5 package rows20240619_44fe6ce0-5fed-418f-8a6a-d6132e288328.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN44fe6ce0-5fed-418f-8a6a-d6132e2883286
1115005docusate sodium 100 MG Oral CapsuleSCD44fe6ce0-5fed-418f-8a6a-d6132e2883286
1115005DOSS Sodium 100 MG Oral CapsuleSY44fe6ce0-5fed-418f-8a6a-d6132e2883286

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-638-10368000638101 BOTTLE, PLASTIC in 1 BOX (36800-638-10) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-02-050000-00-00NoNoCurrent
36800-638-2536800063825250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (36800-638-25) 2021-02-050000-00-00NoNoCurrent
36800-638-60368000638601 BOTTLE, PLASTIC in 1 BOX (36800-638-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-02-050000-00-00NoNoCurrent