FDA.reportPublic FDA data

NDC 77333-812-25 - SIMETHICONE 80MG

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
77333-812
Requested NDC
77333-812-25
Package NDCs from labels
77333-812-25, 77333-812-10
Manufacturer
Gendose Pharmaceuticals, LLC
Effective date
2026-10-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SIMETHICONE 80MG - Gendose Pharmaceuticals, LLCGendose Pharmaceuticals, LLC2026-10-06HUMAN OTC DRUG LABEL
SIMETHICONE 80MG - Cardinal Health 107, LLCCardinal Health 107, LLC2025-12-18HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-05-02GENDOSE - SIMETHICONE 80 mg CHEWABLE TABLETS (77333-812)
2024-05-02GENDOSE - SIMETHICONE 80 mg CHEWABLE TABLETS (77333-812)
2024-01-30GENDOSE - SIMETHICONE 80 mg CHEWABLE TABLETS (77333-812)
2024-01-30GENDOSE - SIMETHICONE 80 mg CHEWABLE TABLETS (77333-812)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-812-10SIMETHICONE 80MG100 in 1 BOXTABLET, CHEWABLE1006
77333-812-25SIMETHICONE 80MG1 in 1 BLISTER PACKTABLET, CHEWABLE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-812SIMETHICONE 80MG (SIMETHICONE) TABLET, CHEWABLE [GENDOSE PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20240504_e7f470cf-f036-afd9-e053-2995a90a9186.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-812-10EA - Each77333-8122df148c8-f505-4408-8018-d6bad416cded12022-10-06
77333-812-25EA - Each77333-812ef4bf287-d8f8-405e-9c5e-d381af05b35712022-10-06

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 9 of 70 · 1,392 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SIMETHICONESIMETHICONEYYBA50250112-933c-ffb1-e063-6394a90aaafb2026-06-09WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP3c448cf7-8ca5-c7f7-e063-6294a90a75ff2026-06-08WarningsExact identifier
unii: 92RU3N3Y1O
BM Calc PhosCALCAREA PHOSPHORICATotal Operations Management LLC DBA:Bestmade Natural Products Micro53ba8260-0f5a-ff74-e063-6294a90ad30a2026-06-08WarningsExact identifier
unii: 91D9GV0Z28
BM SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb3927-6053-eb3d-e063-6394a90a5ddf2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4
INFANTS GAS RELIEFSIMETHICONEMollec Inc53705dbc-daca-2214-e063-6294a90a10972026-06-04WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O
Childrens Simethicone DropsCHILDRENS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma6e26ffbe-4c5b-4689-99bc-88b39ed40a252026-06-04WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O
BM Calc Phos Icing SugarCALCAREA PHOSPHORICATotal Operations Management LLC DBA:Bestmade Natural Products Micro5355390d-9a41-a730-e063-6294a90aa3b62026-06-03WarningsExact identifier
unii: 91D9GV0Z28
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
Quad WashDIMETHICONEDynarex Corporation535dc862-6a18-26c9-e063-6294a90a3d4a2026-06-03WarningsExact identifier
unii: 92RU3N3Y1O
Infants Simethicone DropsINFANTS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma235f458e-c275-4bc1-9c0f-e007c40406492026-06-03WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O
Gas Relief Extra StrengthSIMETHICONECare One (Retail Business Services, LLC.)5e2b25a0-eddf-4d58-927f-bc72c0a92c882026-06-02WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
BM CALC PHOS POTENCYCALC PHOSBM Private Limited5322934b-666b-4cef-e063-6394a90a33622026-05-31WarningsExact identifier
unii: 91D9GV0Z28
REGULAR STRENGTH ANTACID/ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals, Inc.52e75fe4-f04f-31da-e063-6294a90a1e4f2026-05-28WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONECVS PHARMACY, INC4ff77b4c-9616-4341-9bf8-eca301345a5f2026-05-21WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O
Bone Pain ReliefCOMFREY ROOT, TRIBASIC CALCIUM PHOSPHATEBoiron52419c5d-bf46-67ca-e063-6294a90a8fe02026-05-20WarningsExact identifier
unii: 91D9GV0Z28
Phazyme UltimateSIMETHICONEC.B. Fleet Company, Inc.c8e9f6ac-2db2-4d21-a4b1-5ca6c31056622026-05-20WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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