FDA.reportPublic FDA data

NDC 17856-1133-01 - SPIRONOLACTONE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
17856-1133
Requested NDC
17856-1133-01
Package NDCs from labels
17856-1133-3, 17856-1133-1, 17856-1133-2, 17856-1133-4, 17856-1133-5, 17856-1133-6, 17856-1133-7, 17856-1133-8, 17856-1133-01
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2026-08-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SPIRONOLACTONE - ATLANTIC BIOLOGICALS CORP.ATLANTIC BIOLOGICALS CORP.2026-08-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1133-1SPIRONOLACTONE2.5 mL in 1 SYRINGESUSPENSION2.56
17856-1133-1SPIRONOLACTONE1 in 1 BAGSUSPENSION16
17856-1133-4SPIRONOLACTONE2.5 mL in 1 SYRINGESUSPENSION2.56
17856-1133-4SPIRONOLACTONE1 in 1 BAGSUSPENSION16
17856-1133-5SPIRONOLACTONE1 mL in 1 SYRINGESUSPENSION16
17856-1133-5SPIRONOLACTONE120 in 1 CASESUSPENSION1206
17856-1133-6SPIRONOLACTONE3 mL in 1 SYRINGESUSPENSION36
17856-1133-6SPIRONOLACTONE120 in 1 CASESUSPENSION1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1133SPIRONOLACTONE SUSPENSION [ATLANTIC BIOLOGICALS CORP.]1Current NDC, 8 package rows20240605_122558a0-57bb-4195-9adf-d37b049cbfb5.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 68 · 1,342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
SPIRONOLACTONESPIRONOLACTONEATLANTIC BIOLOGICALS CORP.122558a0-57bb-4195-9adf-d37b049cbfb52026-08-26Warnings, Adverse reactionsExact identifier
application number: NDA209478
ndc (package): 17856-1133-8
ndc (package): 17856-1133-1
ndc (package): 17856-1133-7
ndc (package): 17856-1133-5
ndc (package): 17856-1133-6
ndc (package): 17856-1133-3
ndc (package): 17856-1133-4
ndc (package): 17856-1133-2
ndc (product): 17856-1133
ndc11 (package): 17856113301
rxcui: 104232
spl id: 59f7927f-899d-3af9-e063-6394a90aacbd
spl set id: 122558a0-57bb-4195-9adf-d37b049cbfb5
unii: 27O7W4T232
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEPreferred Pharmaceuticals Inc.a96496ff-4b35-4ebe-a6e4-bcfa48fb13412026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
IMODIUM Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE AND DIMETHICONEKenvue Brands LLCecb91e47-2b0c-47c8-9256-4623d8bc825e2026-08-25WarningsExact identifier
unii: 92RU3N3Y1O
SPIRONOLACTONESPIRONOLACTONERedpharm Drug59d86d3a-0f94-0b04-e063-6294a90a83f32026-08-25Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SpironolactoneSPIRONOLACTONECardinal Health 107, LLC48115c9e-c82f-438d-b178-dce1b73687db2026-08-25Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
Gas ReliefSIMETHICONERugby Laboratories9353633b-5718-4366-a943-d49b8076256c2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
HyVee Ultra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc49808dc8-a26e-49f4-e063-6294a90a47962026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
HyVee Extra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc496dd780-fe7c-ced6-e063-6294a90aa5982026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
CVS Health Anti gasSIMETHICONECVS PHARMACY352b1d0e-c6dc-491e-b3e2-c3d9dac3213b2026-08-17WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.