FDA.reportPublic FDA data

NDC 17856-1133-2 - 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
17856-1133-2
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
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 41 of 66 · 1,311 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPIRONOLACTONESPIRONOLACTONEPadagis US LLC522bd365-ddcc-48f4-8a98-66dc4c3bb3142025-01-01Warnings, Adverse reactionsExact identifier
application number: NDA209478
ndc (product): 0574-1133
rxcui: 104232
spl id: 902035fb-dba8-4fdf-9d8d-29d736c07d57
spl set id: 522bd365-ddcc-48f4-8a98-66dc4c3bb314
unii: 27O7W4T232
Maximum Strength Gas Relief SoftgelSIMETHICONECVS PHARMACY, INCde059bd9-40de-432d-9370-5d1e53bd89ac2024-12-30WarningsExact identifier
unii: 92RU3N3Y1O
Personal Cleansing with DimethiconeDIMETHICONECardinal Health 200, Inc3f9a1a90-ab12-4911-b8c2-df200b0dde5b2024-12-27WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONETopco Associates, LLCc90d68a0-22e1-4a37-8487-16ecdc431ede2024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Regular Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC59c16c09-c23d-4a37-8460-d6c00a268ed52024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone Certified PlusSIMETHICONEAdvance Pharmaceutical Inc.d087743f-b82f-2a5c-e053-2995a90abb202024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
GNP Regular Strength Gas ReliefDIMETHICONEAmerisource Bergen7b63b265-e4f2-4103-935c-22d2d89cc5e82024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Antacid Cherry liquidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC31d2e77d-5eda-4f47-917c-3390d6c782af2024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC50ceff1e-b6df-40f8-89f3-667cc8f9e7502024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Infants Gas reliefSIMETHICONETopco Associates, LLCfd6a2537-8db2-492d-b045-6404df2fb9c32024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEH E Bf294cf44-fb21-4b2e-8b7c-efd41416c6b22024-12-26WarningsExact identifier
unii: 92RU3N3Y1O
Tucks Triple Relief HemorrhoidalWHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEBlistex Inc.bf892e90-2d9b-4fa0-8ee4-8a2736be6c302024-12-24WarningsExact identifier
unii: PDC6A3C0OX
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.4e15f6ca-a40c-485f-be3f-07c2ed7cb4982024-12-23WarningsExact identifier
unii: PDC6A3C0OX
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
unii: PDC6A3C0OX
LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin ProtectantDIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Ince8539a43-db85-451c-bce8-2c488f3dc40d2024-12-23WarningsExact identifier
unii: 92RU3N3Y1O
Infants Gas reliefSIMETHICONEUNITED NATURAL FOODS, INC. DBA UNFIa9902ba0-f239-4e66-8d66-7cef39a5fdc32024-12-20WarningsExact identifier
unii: 92RU3N3Y1O
maximum strength antacid cherryALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEUNITED NATURAL FOODS, INC. DBA UNFId6b49f0a-cf05-4b1b-8cad-c5795aa316452024-12-20WarningsExact identifier
unii: 92RU3N3Y1O
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
unii: PDC6A3C0OX
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
unii: PDC6A3C0OX
WinCo Foods Gas Relief Extra Strength SoftgelsSIMETHICONEWinCo Foods, LLCa1a19ef7-4a14-4fcb-8917-631d867be0bb2024-12-18WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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