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 5 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Pain Relieving Cream with Menthol 10%MENTHOL 10% CREAMONE2ZEE LIMITED LIABILITY COMPANYae09e93f-3988-4477-ae53-b2f3df9769fb2025-05-05WarningsExact identifier
application number: M
Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.edf07b7f-46fb-4915-b2ea-83d852617f602025-04-10WarningsExact identifier
application number: M
BRONCOCHEM KIDS COLD AND FLUACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb6559fb9-2dea-49c0-a274-3e77741a0ffd2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGHDEXTROMETHORPHAN HBR-GYAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLdeecdb72-4cdb-4d6f-972f-a425a91afa5a2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLdffdfa2c-a52e-4606-9b07-c8993e499f092025-03-23WarningsExact identifier
application number: M
BRONCOCHEM EXPECTORANT IIACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCLLABORATORIO MAGNACHEM INTERNATIONAL SRL1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a2025-03-23WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH KIDSDEXTROMETHORPHAN HBR-GUAIFENESINLABORATORIO MAGNACHEM INTERNATIONAL SRLb0fd2f2f-5cc4-4813-8f99-c78fbe8986562025-03-13WarningsExact identifier
application number: M
Menthol Pain Relief Gel PatchMENTHOL PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANYeab185d6-2a54-489d-8114-fe8088624ba42025-03-04WarningsExact identifier
application number: M
Lidocaine 4% Pain Relief Gel PatchLIDOCAINE 4% PAIN RELIEF GEL PATCHONE2ZEE LIMITED LIABILITY COMPANY8e5a4ef4-b928-44b3-842c-92f1531af75b2025-03-03WarningsExact identifier
application number: M
gas reliefSIMETHICONEStrategic Sourcing Services LLC23005295-c5f2-4a76-8431-4a9b8d817d4d2025-01-03WarningsExact identifier
application number: M
Foster and Thrive infants Gas reliefSIMETHICONEStrategic Sourcing Services LLC824c9dff-0a26-4710-a25b-39df631d6fa62024-12-13WarningsExact identifier
application number: M
BRONCOCHEM COLD AND FLU TEAACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRLb7d3f54e-59ef-4b85-a88d-b053058dc1f62024-12-12WarningsExact identifier
application number: M
HYSAN PAIN RELIEVERMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDbad73234-c204-40a8-8176-45c75ae500c82024-10-07WarningsExact identifier
application number: M
HYSAN ANALGESICMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTD99a13b0a-1d77-479e-ba99-2cfa638de3392024-10-04WarningsExact identifier
application number: M
HYSAN HUO LU MEDICATEDMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDfe9eeaff-fcbf-4287-9f17-bcf1822bf35b2024-10-04WarningsExact identifier
application number: M
HYSAN HUA TUO MEDICATEDMETHYL SALICYLATEHYSAN PHARMACEUTICAL CO LTDb84c4d33-5a77-46e0-b04e-32f73967bd1c2024-10-04WarningsExact identifier
application number: M
HYSAN HUA TUO HUO LUMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDcd2288c4-9909-43c1-91da-b15545b097882024-10-04WarningsExact identifier
application number: M
CLARINS - ROLL-ON DEODORANT Aluminum Chlorohydrate - Antiperspirant, Long-lasting Alcohol-freeALUMINUM CHLOROHYDRATELaboratoires Clarins412116a1-f9af-4c03-85e0-aad5738dd7972024-08-05WarningsExact identifier
application number: M
BRONCOCHEM MAXIMUM COUGH NIGHTDEXTROMETHORPHAN HBR-PYRILAMINE MALEATELABORATORIO MAGNACHEM INTERNATIONAL SRL1a3ed214-e09b-4266-b68b-39e7c3127d262024-04-22WarningsExact identifier
application number: M
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions835c3c23-fc3c-404e-8e87-5a01761267302024-02-28WarningsExact 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