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 10 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEP & L Development, LLC7a461b91-d11f-4cb9-be61-c7d91d2783022024-04-16WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEGobrands, Inc. (Goodnow)cd647eb7-6e03-415c-8249-89c126824d002024-04-03WarningsExact identifier
application number: M008
Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATECare One (Retail Business Services, LLC.)c443b640-18b0-4b7d-a13c-0accb915a8012024-03-05WarningsExact identifier
application number: M008
Stomach Relief - Regular StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.970b4118-2c2e-4806-8fe8-937ba06cf6e92023-12-30WarningsExact identifier
application number: M008
Stomach Relief, Maximum StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.cdd436f6-b769-49aa-9e6c-da512da9e6e32023-12-30WarningsExact identifier
application number: M008
Stomach Relief - Maximum StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.15cd9163-16d6-4332-9e26-77c05e0a26a72023-12-30WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEDemoulas Super Markets Inc9a95d198-f3ba-4bc3-a6f1-e065eb7e86f02023-12-29WarningsExact identifier
application number: M008
Stomach Relief Maximum StrengthBISMUTH SUBSALICYLATEDemoulas Super Markets Incb2d55045-d4a4-4167-a20c-42932f35bab22023-12-29WarningsExact identifier
application number: M008
STOMACH RELIEFBISMUTH SUBSALICYLATEConsumer Value Products, Inc.7526a3f2-ce7c-46c8-8ddf-1bcaf313876d2023-12-29WarningsExact identifier
application number: M008
Estomaquil PolvoBISMUTH SUBSALICYLATEProMex LLCcf94c99a-c489-45ec-bb13-3e6959e377de2023-11-29WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECare One (Retail Business Services, LLC.)3c53adaa-275f-4164-b21e-285e4f03433e2023-10-05WarningsExact identifier
application number: M008
Pepto-Bismol Chewable, TRAVEL BASIXBISMUTH SUBSALICYLATELil' Drug Store Products, Inc.dd2f2205-34d1-4960-bf37-bb8d534cd0e12023-10-03WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATECDMA- QCfe3cd0ce-933b-4ad3-a34f-c057a93561582021-06-16WarningsExact identifier
application number: M008
Topcare Stomach Relief Original StrengthBISMUTH SUBSALICYLATETopCo Associates, LLCe4b1929c-0967-44ea-8552-6549aa2a464e2018-12-14WarningsExact identifier
application number: M008
BismuthBISMUTH SUBSALICYLATEAllegiant Health015ca07a-f6b5-4741-a7b0-821cf6d4e4182018-11-07WarningsExact identifier
application number: M008
GastrobizBISMUTH SUBSALICYLATEAllegiant Healthaa516512-afd7-453f-9c73-5fa930cafac32018-09-11WarningsExact identifier
application number: M008
Pep TumBISMUTH SUBSALICYLATEFirst Aid Directbf966e9f-2f95-41cd-a6e5-b8eb521181d82017-12-22WarningsExact identifier
application number: M008
Bismuth ChewableBISMUTH SUBSALICYLATE 262 MGMarc Glassman, Inc.cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e2016-12-19WarningsExact 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