FDA.reportPublic FDA data

Senna

Product NDC
0904-7528
11-digit product format
009047528
Labeler code
0904
Product ID
0904-7528_77e88305-734a-4b15-bbfe-67a32f02c143
Type
HUMAN OTC DRUG
Nonproprietary name
sennosides
Dosage form
LIQUID
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-06
Substance
SENNOSIDES
Active strength
8.8 mg/5mL
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
Senna
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES8.8 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FYP5M0IJXInternal 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
cfb6bf89-c77e-4372-9bc9-44d6a659c955Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7528-41Senna5 mL in 1 CUP, UNIT-DOSELIQUID54
0904-7528-94Senna10 in 1 TRAYLIQUID104
0904-7528-94Senna4 in 1 CASELIQUID44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7528-41ML - Milliliter0904-75280dca331c-3b4f-4b5c-a790-de8da681541712025-05-14
0904-7528-94ML - Milliliter0904-7528cbef6a9d-7673-48a6-bf20-a9ab7ec3780812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7528SENNA (SENNOSIDES) LIQUID [MAJOR PHARMACEUTICALS]3Current NDC, 3 package rows20250308_cfb6bf89-c77e-4372-9bc9-44d6a659c955.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 3 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KaopectateBISMUTH SUBSALICYLATEKramer Laboratories3877a88d-9546-48ce-ad6b-3c2a115e3eaf2026-06-03WarningsExact identifier
application number: M008
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.f0976d6c-d574-49e8-b98a-23a660d83fa02026-06-02WarningsExact identifier
application number: M008
Stomach Relief Maximum StrengthBISMUTH SUBSALICYLATECVS Pharmacy9d8f2456-732d-40bf-a10c-98423560c0292026-05-13WarningsExact identifier
application number: M008
Green Guard Instydose Upset Stomach ReliefBISMUTH SUBSALICYLATEUnifirst First Aid Corporation5b1f31a9-8eec-4c3d-e063-6394a90a2efe2026-05-01WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)6f189c12-eb94-476e-a8f7-ea82f44c4aa52026-04-13WarningsExact identifier
application number: M008
Pepto BismolBISMUTH SUBSALICYLATENavajo Manufacturing Company Inc.033bccc6-6e81-487f-91fe-9d7cc465e1b22026-04-08WarningsExact identifier
application number: M008
SootheBISMUTH SUBSALICYLATEWalgreens450483c3-487f-4a8f-a439-5661241a8f0f2026-04-08WarningsExact identifier
application number: M008
GS Stomach ReliefBISMUTH SUBSALICYLATE 525 MGGood Sense (Geiss, Destin & Dunn, Inc.)edd15c7d-f66b-4b1a-8cda-9814a37904832026-03-31WarningsExact identifier
application number: M008
WALGREEN ULTRA STRENGTH PINK BISMUTHBISMUTH SUBSALICYLATEWALGREENS CO.d0f78754-2556-4aa8-949b-a6e3b4adf8c22026-03-25WarningsExact identifier
application number: M008
Dr. Simi Stomach ReliefBISMUTH SUBSALICYLATE 525 MGFarmacias De Similares TX LLC4dc9233e-68fb-e1e8-e063-6294a90aee332026-03-24WarningsExact identifier
application number: M008
Major Bismuth SubsalicylateBISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.69b9999f-c2e5-43a6-891f-0e24d3c343a42026-03-20WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEGrocery Outlet, Inc.4465dd17-c333-7b95-e063-6294a90a50532026-03-19WarningsExact identifier
application number: M008
AMAZON Regular StrengthBISMUTH SUBSALICYLATEAMAZON.COM SERVICES LLC6b41f36d-1810-45f7-a46c-67b9bff237382026-03-04WarningsExact identifier
application number: M008
AMAZON Digestive ReliefBISMUTH SUBSALICYLATEAMAZON.COM SERVICES LLCa9a676d8-06b9-43bf-9c06-08670c9ab2112026-03-04WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEWal-Mart Stores Inc2d7d563e-4c46-4788-b6a7-5b92e3d585332026-02-26WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEChain Drug Marketing Association, Inc.d63110ee-2d64-46dd-80bf-696c9b9d8d7c2026-02-26WarningsExact identifier
application number: M008
SIGNATURE CARE Ultra Strength StomachBISMUTH SUBSALICYLATESAFEWAY4b54fa21-d8ea-4497-aa32-17e47669c8e12026-02-20WarningsExact identifier
application number: M008
SIGNATURE CARE Regular StrengthBISMUTH SUBSALICYLATESAFEWAYb4643d99-90ce-4f00-a61a-a5371fe0f4242026-02-20WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEGrocery Outlet, Inc.44673b4f-1bf8-9db3-e063-6294a90a62f52026-02-14WarningsExact identifier
application number: M008
Treda UltraBISMUTH SUBSALICYLATELaboratorios Sanfer, S.A. de C.V.cfa7f37a-e18b-4929-b3a4-4126b0aa679a2026-02-12WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702311sennosides 8.8 MG in 5 mL Oral SolutionPSNcfb6bf89-c77e-4372-9bc9-44d6a659c9554
702311sennosides, USP 1.76 MG/ML Oral SolutionSCDcfb6bf89-c77e-4372-9bc9-44d6a659c9554
702311sennosides 8.8 MG per 5 mL Oral SyrupSYcfb6bf89-c77e-4372-9bc9-44d6a659c9554
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSYcfb6bf89-c77e-4372-9bc9-44d6a659c9554
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSYcfb6bf89-c77e-4372-9bc9-44d6a659c9554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7528-41009047528415 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0904-7528-94009047528944 TRAY in 1 CASE (0904-7528-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7528-41) 4 tray2025-03-06NoNoCurrent