FDA.reportPublic FDA data

OneLAX SENNA

Product NDC
17856-1127
11-digit product format
178561127
Labeler code
17856
Product ID
17856-1127_471b1175-9499-7889-e063-6394a90aa6dd
Type
HUMAN OTC DRUG
Nonproprietary name
SENNA
Dosage form
SYRUP
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-06
Substance
SENNOSIDES A AND B
Active strength
417.12 mg/237mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
OneLAX SENNA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES A AND B417.12 mg/237mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1B5FPI42ENInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702311Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2a5a13a-e7e4-488a-b60b-4dd467efa971Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1127-1OneLAX SENNA120 in 1 BOX, UNIT-DOSESYRUP1204
17856-1127-2OneLAX SENNA72 in 1 BOX, UNIT-DOSESYRUP724
17856-1127-3OneLAX SENNA72 in 1 BOX, UNIT-DOSESYRUP724
17856-1127-4OneLAX SENNA72 in 1 BOX, UNIT-DOSESYRUP724
17856-1127-5OneLAX SENNA2.5 mL in 1 SYRINGESYRUP2.54
17856-1127-6OneLAX SENNA5 mL in 1 CUP, UNIT-DOSESYRUP54
17856-1127-7OneLAX SENNA10 mL in 1 CUP, UNIT-DOSESYRUP104
17856-1127-8OneLAX SENNA15 mL in 1 CUP, UNIT-DOSESYRUP154
17856-1127-9OneLAX SENNA120 in 1 BOX, UNIT-DOSESYRUP1204
17856-1127-9OneLAX SENNA2.5 mL in 1 SYRINGESYRUP2.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-1127-1ML - Milliliter17856-1127c08714e3-905e-4e20-97c1-043685cae09712024-06-10
17856-1127-2ML - Milliliter17856-112766cf67fe-098b-44ed-af11-ea6e69bd17a712024-06-10
17856-1127-3ML - Milliliter17856-1127e067a394-8c02-4ce9-a6a7-be9ca07d796c12024-06-10
17856-1127-4ML - Milliliter17856-1127c419747c-7cee-4a84-a0ab-0b787a39532912024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1127ONELAX SENNA (SENNA) SYRUP [ATLANTIC BIOLOGICALS CORP.]2Current NDC, 10 package rows20250525_d2a5a13a-e7e4-488a-b60b-4dd467efa971.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 36 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFIb1d903a5-1d5f-44d4-9939-a4b86e5a620d2024-05-23WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESUnited Natural Foods, Inc. dba UNFI30b9bbf3-0a64-41de-bfb4-5c8c257cc3e82024-05-23WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEMEIJER, INC.11fe5bd0-585a-ad8a-e063-6294a90a3ae82024-05-22WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMSam's West, Incb14d2495-1092-4063-869f-73a7e8c287082024-05-21WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESSafeway, Inc.6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d2024-05-15WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESSafeway, Inc.c0898583-4bbb-41d5-9e84-00cca823024f2024-05-15WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)9c986ca8-d540-49c1-b092-94c1bf837c072024-05-09WarningsExact identifier
application number: M007
FleetGLYCERINC.B. Fleet Company, Inc.381f4179-0c3b-41f8-927c-c88534ebe06d2024-05-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.ed20d198-e935-200e-e053-2a95a90a309b2024-05-02WarningsExact identifier
application number: M007
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMMajor Pharmaceuticals1768b470-2808-fa46-e063-6394a90ac8d92024-05-01WarningsExact identifier
application number: M007
Stool Softener Stimulant laxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)9467e1f7-19bb-4fb3-853b-75c4d28bb9a92024-05-01WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)72f8e8d7-ee38-4bd3-8711-f11fded0cede2024-05-01WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMP & L Development, LLCc1e9863a-c229-4694-b450-6b0e0ad375032024-04-30WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMQUALITY CHOICE (Chain Drug Marketing Association)96c7f8bc-be95-40d1-9977-44b7cc6582df2024-04-22WarningsExact identifier
application number: M007
Pedia-LaxMAGNESIUM HYDROXIDEC.B. Fleet Company, Inc.975f24d8-218c-40f4-84a5-558acf34329d2024-04-11WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESH E B2f9e2723-53a7-47a8-8c41-87bffc4e50dd2024-04-09WarningsExact identifier
application number: M007
SennaSENNOSIDESH E Bd047e4e9-b8ac-498e-9fde-8af5d415edaa2024-04-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMH E B5b8bcc6c-de03-4d73-a76f-6f4c371cf2502024-04-09WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMH E B1dd2be7e-bdca-4e43-b853-3ed10b6366322024-04-08WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack1f11cf85-b094-4ca4-8b48-2d3a9093304b2024-04-04WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702311sennosides 8.8 MG in 5 mL Oral SolutionPSNd2a5a13a-e7e4-488a-b60b-4dd467efa9714
702311sennosides, USP 1.76 MG/ML Oral SolutionSCDd2a5a13a-e7e4-488a-b60b-4dd467efa9714
702311sennosides 8.8 MG per 5 mL Oral SyrupSYd2a5a13a-e7e4-488a-b60b-4dd467efa9714
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSYd2a5a13a-e7e4-488a-b60b-4dd467efa9714
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSYd2a5a13a-e7e4-488a-b60b-4dd467efa9714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-1127-117856112701120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1127-1) / 2.5 mL in 1 SYRINGE (17856-1127-5) 120 syringe2024-03-05NoNoCurrent
17856-1127-21785611270272 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1127-2) / 5 mL in 1 CUP, UNIT-DOSE (17856-1127-6) 2024-03-05NoNoCurrent
17856-1127-31785611270372 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1127-3) / 10 mL in 1 CUP, UNIT-DOSE (17856-1127-7) 2024-03-05NoNoCurrent
17856-1127-41785611270472 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1127-4) / 15 mL in 1 CUP, UNIT-DOSE (17856-1127-8) 2024-03-05NoNoCurrent
17856-1127-5178561127052.5 mL in 1 SYRINGE2.5 mlHistorical
17856-1127-6178561127065 mL in 1 CUP, UNIT-DOSE5 mlHistorical
17856-1127-71785611270710 mL in 1 CUP, UNIT-DOSE10 mlHistorical
17856-1127-81785611270815 mL in 1 CUP, UNIT-DOSE15 mlHistorical
17856-1127-917856112709120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1127-9) / 2.5 mL in 1 SYRINGE120 syringe2025-12-29NoNoCurrent