FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
51316-107
11-digit product format
513160107
Labeler code
51316
Product ID
51316-107_e8090087-73dd-4918-b9eb-deeae979b765
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-30
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-107-10Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1005
51316-107-25Stool Softener Laxative1 in 1 BOXCAPSULE, LIQUID FILLED15
51316-107-25Stool Softener Laxative25 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-107STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC]4Current NDC, 3 package rows20240316_056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a138.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a1385
1115005docusate sodium 100 MG Oral CapsuleSCD056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a1385
1115005DOSS Sodium 100 MG Oral CapsuleSY056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a1385

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51316-107-1051316010710100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51316-107-10) 2022-12-30NoNoCurrent
51316-107-25513160107251 BOTTLE, PLASTIC in 1 BOX (51316-107-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2022-12-30NoNoCurrent