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 7 of 73 · 1,448 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Gas ReliefGAS RELIEFChain Drug Marketing Association, Inc.912f896b-ff49-40e6-b425-c314e0cbf48e2026-06-30WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEStrategic Sourcing Services LLC0add7687-f9d7-4f70-b9a8-1454db8a7caf2026-06-29WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eab581-bc48-f9f0-e063-6394a90a4b932026-06-25Exact identifier
unii: IY9XDZ35W2
Gas Relief Extra StrengthSIMETHICONEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)447ee411-f4b9-4dd1-a3e0-36ad79bccbf92026-06-25WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: 91D9GV0Z28
Leukotrap WB system - CP2DCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54fdf3cf-41df-af7d-e063-6294a90ab1e62026-06-24Exact identifier
unii: IY9XDZ35W2
Blood Collection SystemCP2D/AS-3 TRIPLE WITH SAMPLING SYSTEMGVS TM INC54e8cfd2-f91b-8381-e063-6394a90a3f772026-06-23Exact identifier
unii: IY9XDZ35W2
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54e9a497-7a94-44c9-e063-6294a90a84da2026-06-23Exact identifier
unii: IY9XDZ35W2
Leukotrap RC PL SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eb0462-cd00-4467-e063-6394a90aa3712026-06-23Exact identifier
unii: IY9XDZ35W2
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54eb3c81-5cc8-03c4-e063-6294a90a20652026-06-23Exact identifier
unii: IY9XDZ35W2
Leukotrap RC SystemCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC54ebb700-3bcf-d0e3-e063-6394a90a57c82026-06-23Exact identifier
unii: IY9XDZ35W2
Comfort Shield BarrierDIMETHICONESage Products LLCcc08f571-84ae-4c2f-b09d-a83a8efc39f52026-06-23WarningsExact identifier
unii: 92RU3N3Y1O
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 92RU3N3Y1O
BM BIO24 ICING SUGARCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOSTotal Operations Management LLC DBA:Bestmade Natural Products Micro544b2bf9-74e8-297f-e063-6394a90a3dac2026-06-15WarningsExact identifier
unii: 91D9GV0Z28
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
BM BM204 DROPSBARYTA CARB, CALC PHOS, IODIUM, LYCOPUS VIR, CALC CARBTotal Operations Management LLC DBA:Bestmade Natural Products Micro543bab2a-7222-3bbe-e063-6394a90a8aae2026-06-14WarningsExact identifier
unii: 91D9GV0Z28
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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