FDA.reportPublic FDA data

Relief

Product NDC
69626-0084
11-digit product format
696260084
Labeler code
69626
Product ID
69626-0084_27477e10-e566-a526-e063-6394a90a7590
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM PHOSPHATE, MONOBASIC and SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
Dosage form
ENEMA
Route
RECTAL
Labeler
Leosons Overseas Corp
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-09
Substance
SODIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
Active strength
19; 7 g/133mL; g/133mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69626-0084-6e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69626-0084-69bebd1f3094a…5416666fcb17…

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
Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM PHOSPHATE, MONOBASIC19 g/133mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE7 g/133mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3980JIH2SWInternal UNII lookup
70WT22SF4BInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b301d5b-1e2c-47ed-a05f-d6be0fdfc940Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69626-0084-62020-12-18C16284748780-19d75b9d0-ddfb-f424-e053-dadaa90a57ceRelief Saline Laxative 4.5 fl oz
69626-0084-62020-01-31C16284748780-19d75b9d0-ddfb-f424-e053-dadaa90a57ceRelief Saline Laxative 4.5 fl oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69626-0084-6Relief133 mL in 1 BOTTLE, WITH APPLICATORENEMA1334
69626-0084-6Relief1 in 1 CARTONENEMA14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEACTIVE INGREDIENT70WT22SF4BRELIEF (SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE) ENEMA [LEOSONS OVERSEAS CORP]1
SODIUM PHOSPHATE, MONOBASICACTIVE INGREDIENT3980JIH2SWRELIEF (SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE) ENEMA [LEOSONS OVERSEAS CORP]1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRRELIEF (SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE) ENEMA [LEOSONS OVERSEAS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7RELIEF (SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE) ENEMA [LEOSONS OVERSEAS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KRELIEF (SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE) ENEMA [LEOSONS OVERSEAS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RRELIEF (SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE) ENEMA [LEOSONS OVERSEAS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69626-0084RELIEF (SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE) ENEMA [LEOSONS OVERSEAS CORP]4Current NDC, Legacy NDC, 2 package rows20241121_5b301d5b-1e2c-47ed-a05f-d6be0fdfc940.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 25 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Docusate Sodium Oral LiquidDOCUSATE SODIUM ORAL LIQUIDKesin Pharma Corporation331277b8-8304-d082-e063-6394a90a4dd32025-04-18WarningsExact identifier
application number: M007
Mineral OilMINERAL OILAmerisourceBergen (Good Neighbor Pharmacy) 46122581f81a0-7488-4c90-b33e-06c6301a4fd22025-04-17WarningsExact identifier
application number: M007
Vegetable LaxativeSENNOSIDESWalmart Inc.26dc60e7-5a05-64c3-e063-6394a90a55ce2025-04-14WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEStrategic Sourcing Services LLC99aa30ed-9659-4f60-a31d-6aaf09909b512025-04-14WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILGeri-Care Pharmaceutical Corp616b4399-7626-5e59-e053-2a91aa0a0f752025-04-07WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILCITRAGEN PHARMACEUTICALS, INC.b23dd90f-ba5a-80fc-e053-2995a90a22862025-04-03WarningsExact identifier
application number: M007
Phillips Milk Of Magnesia Wild CherryPHILLIPS MILK OF MAGNESIA WILD CHERRYBayer HealthCare LLC.0a6d824a-3d9a-07f9-e054-00144ff8d46c2025-04-01WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECVS PHARMACY30ce5cbd-cc7a-0b2d-e063-6394a90a85202025-03-20WarningsExact identifier
application number: M007
SennaSENNOSIDESAARNA USA INC.7ad21fb7-20eb-48d6-be15-450aa2ec97d32025-03-20WarningsExact identifier
application number: M007
CVS Health Stool Softener Plus stimulant laxative SoftgelDOCUSATE SODIUM, SENNOSIDESCVS Pharmacy, Inc2881d83d-9929-677a-e063-6394a90a04242025-03-19WarningsExact identifier
application number: M007
Mineral OilMINERAL OILKesin Pharma Corporation30a11cc9-e407-23b7-e063-6294a90a7d6e2025-03-18WarningsExact identifier
application number: M007
CVS Magnesium Hydroxide Laxative ChewMAGNESIUM HYDROXIDECVS30126c74-6f5c-72f3-e063-6394a90ad81f2025-03-11WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTGood Sense (Geiss, Destin & Dunn, Inc.)c7a9f180-9c73-4317-adbe-f95702fb48022025-03-03WarningsExact identifier
application number: M007
Magnesium Citrate Saline LaxativeMAGNESIUM CITRATEAARNA USA INC.e7550220-df26-4a7a-a254-bebb225d9e5e2025-03-01WarningsExact identifier
application number: M007
Fiber laxativeCALCIUM POLYCARBOPHILDiscount Drug Mart, Inc2e0c4736-3d27-e088-e063-6294a90aeca82025-02-27WarningsExact identifier
application number: M007
Mineral oilMINERAL OILP & L Development, LLC68e88119-1468-4ab7-a5fa-242d960d25df2025-02-21WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEWhole Foods Market5a88048e-5417-4d8e-a149-f51610a5d4202025-02-19WarningsExact identifier
application number: M007
SennosidesSENNOSIDESPD-Rx Pharmaceuticals, Inc.829d24b7-a46a-4a29-88fe-180f35a2b6cd2025-02-18WarningsExact identifier
application number: M007
Stool Softener and Stimulant LaxativeDOCUSATE SODIUM, SENNOSIDESH-E-Bc19280c2-f968-b582-e053-2995a90a9bd32025-02-14WarningsExact identifier
application number: M007
STOOL SOFTENER-STIMULANT LAXATIVESTOOL SOFTENER-STIMULANT LAXATIVEKroger Companya22c9f95-e3a9-bfd3-e053-2995a90a3c662025-02-13WarningsExact identifier
application number: M007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69626-0084-6696260084061 BOTTLE, WITH APPLICATOR in 1 CARTON (69626-0084-6) / 133 mL in 1 BOTTLE, WITH APPLICATOR2015-02-090000-00-00NoNoCurrent