FDA.reportPublic FDA data

Docusate Sodium

Product NDC
55289-493
11-digit product format
552890493
Labeler code
55289
Product ID
55289-493_54129d13-ffb2-2e6d-e063-6394a90a6290
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-01
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Docusate Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115005Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
66ca7a94-378b-4476-8060-d9c6f82f57fcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-493-01Docusate Sodium100 in 1 BOTTLE, PLASTICCAPSULE10019
55289-493-12Docusate Sodium12 in 1 BOTTLE, PLASTICCAPSULE1219
55289-493-14Docusate Sodium14 in 1 BOTTLE, PLASTICCAPSULE1419
55289-493-30Docusate Sodium30 in 1 BOTTLE, PLASTICCAPSULE3019
55289-493-60Docusate Sodium60 in 1 BOTTLE, PLASTICCAPSULE6019
55289-493-90Docusate Sodium90 in 1 BOTTLE, PLASTICCAPSULE9019
55289-493-93Docusate Sodium180 in 1 BOTTLE, PLASTICCAPSULE18019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-493-01EA - Each55289-4933c49bdc5-bd16-4d64-91f8-2678df40de7212023-06-06
55289-493-12EA - Each55289-49323f7085f-daef-48e6-87f0-8403f94df9b412021-05-05
55289-493-14EA - Each55289-493b613e57f-640f-4f63-a125-120bb2247d6d12018-04-19
55289-493-30EA - Each55289-4934f9252c6-8cec-468c-8398-30f72580f94712018-04-19
55289-493-60EA - Each55289-493079ae045-5df5-4b00-a74c-90e64c52be1e12018-04-19
55289-493-90EA - Each55289-493c575b1bb-c86e-436f-9610-e24584257f6412018-04-19
55289-493-93EA - Each55289-493b3bfe6d0-cc05-415c-aa3a-e7179ecec52e12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-493DOCUSATE SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 7 package rows20240314_66ca7a94-378b-4476-8060-d9c6f82f57fc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Street Antibacterial Liquid HandBENZALKONIUM CHLORIDEAmerifoods Trading Companye9d5fefa-970b-42ba-8139-18e5644153442025-11-06WarningsExact identifier
application number: M
CetirzaCETIRIZINE HCLHART Health44b22f6f-5731-4dfe-af33-4e4e54fc3af52025-10-06WarningsExact identifier
application number: M
Dolce and Gabbana Blueberry Nutri Tint SPF 20 6W LightZINC OXIDEDolce & Gabbana Beauty S.R.Ld2930d0e-c622-4843-87f2-fa1a92837ff22025-09-05WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLNorMed959815e5-a73b-4905-9d7d-904b334983862025-08-15WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthc1903b9f-390a-4756-800c-fd93be4182e32025-08-13Warnings, Adverse reactionsExact identifier
application number: M
THERASTATCHERRY COUGH DROPSHART Health96bae19a-3337-4199-9b8c-cdf9b368178b2025-08-04WarningsExact identifier
application number: M
Docu LiquidDOCUSATE SODIUMATLANTIC BIOLOGICALS CORP.f4ed0721-3be9-4108-a6c9-dbbe115249e92025-07-31WarningsExact identifier
application number: M
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEATLANTIC BIOLOGICALS CORP.ac6a47e7-972f-4b82-96da-89926d345e9f2025-07-31WarningsExact identifier
application number: M
SENNASENNAATLANTIC BIOLOGICALS CORP.8b7cc0d5-029b-43f7-a050-8771e7db45512025-07-31WarningsExact identifier
application number: M
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGATLANTIC BIOLOGICALS CORP.4c02fcec-6bb7-4497-96c5-0d809209dd172025-06-27WarningsExact identifier
application number: M
Orythia Pain Relieving LidocaineLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.d658d495-dd2c-40b7-9446-6f10040ed55e2025-06-27WarningsExact identifier
application number: M
Bonica EaseX Pain RelievingCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.34f1196a-fda1-4bef-be71-e5a09ee97bc12025-06-27WarningsExact identifier
application number: M
Regular Strength Enteric coated aspirinASPIRINATLANTIC BIOLOGICALS CORP.e1c8d0ed-da1d-4b1a-9a85-7b8532775f872025-06-24WarningsExact identifier
application number: M
Aspirin Low Dose Chewable OrangeASPIRINATLANTIC BIOLOGICALS CORP.a0d8ee59-1ce0-4ddd-a90c-54adb512540c2025-06-24WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEHART Healthf50af223-ba83-458a-a557-1ba5dc221a9c2025-06-10WarningsExact identifier
application number: M
Pharbetol Regular strengthACETAMINOPHENATLANTIC BIOLOGICALS CORP.05a91d24-b498-4ba2-a275-68b871cf62d22025-06-05WarningsExact identifier
application number: M
TEENY TUMMY Gas Relief DropsSIMETHICONEATLANTIC BIOLOGICALS CORP376660a2-becb-48cf-a9f5-6a76a8b8ca702025-05-30WarningsExact identifier
application number: M
Mineral OilMINERAL OILATLANTIC BIOLOGICALS CORP.960502ae-2468-406e-8799-cacb01f2727e2025-05-23WarningsExact identifier
application number: M
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEATLANTIC BIOLOGICALS CORP.5c02d0ba-91e4-4bd2-ac66-6905323653b22025-05-12WarningsExact identifier
application number: M
MAX Tussin Cough and Chest Congestion DM Sugar FreeDEXTROMETHORPHAN HBR, GUAIFENESINATLANTIC BIOLOGICALS CORP.8f496c61-41a6-41ba-80f5-7a5309c4d18b2025-05-12WarningsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN66ca7a94-378b-4476-8060-d9c6f82f57fc19
1115005docusate sodium 100 MG Oral CapsuleSCD66ca7a94-378b-4476-8060-d9c6f82f57fc19
1115005DOSS Sodium 100 MG Oral CapsuleSY66ca7a94-378b-4476-8060-d9c6f82f57fc19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-493-0155289049301100 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-01) 100 capsule2023-05-18NoNoCurrent
55289-493-125528904931212 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-12) 12 capsule2021-04-210000-00-00NoNoCurrent
55289-493-145528904931414 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-14) 14 capsule2018-01-120000-00-00NoNoCurrent
55289-493-305528904933030 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-30) 30 capsule2018-01-122038-01-31NoNoCurrent
55289-493-605528904936060 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-60) 60 capsule2018-01-120000-00-00NoNoCurrent
55289-493-905528904939090 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-90) 90 capsule2018-01-120000-00-00NoNoCurrent
55289-493-9355289049393180 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-93) 180 capsule2023-03-282038-01-31NoNoCurrent