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 8 of 70 · 1,392 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM96 DROPSAGRAPHIS NUTANS, HYDRASTIS CAN, BARYTA IOD., BARYTA MUR., CALCAREA IOD., CALCAREA PHOS., CISTUS CANBM Private Limited540bc176-74f3-cd39-e063-6294a90a00462026-06-12WarningsExact identifier
unii: 91D9GV0Z28
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM204 DROPSBARYTA CARB, CALC PHOS, IODIUM, LYCOPUS VIR, CALC CARBBM Private Limited540e177d-83e1-cf8a-e063-6394a90ad5a22026-06-12WarningsExact identifier
unii: 91D9GV0Z28
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro540e4ee3-596f-4cea-e063-6294a90a6a602026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM96 DROPSAGRAPHIS NUTANS, HYDRASTIS CAN, BARYTA IOD., BARYTA MUR., CALCAREA IOD., CALCAREA PHOS., CISTUS CANTotal Operations Management LLC DBA:Bestmade Natural Products Micro5411ad88-bc3a-0563-e063-6294a90a28302026-06-12WarningsExact identifier
unii: 91D9GV0Z28
Jacksons Cell Salts SKIN BALANCECALC SULPH, KALI SULPH, SILICEAZettl Health Inc.54012f03-4c34-42f5-e063-6394a90aacc52026-06-11WarningsExact identifier
unii: ETJ7Z6XBU4
Mag-Al PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONECardinal Health 107, LLC08df7403-9ee3-4a43-a151-c1a6ef7a75492026-06-10WarningsExact identifier
unii: 92RU3N3Y1O
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCBM Private Limited53e763ee-9a44-a914-e063-6394a90aeb3c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts 5 IN 1 PHOSCALC PHOS, FERRUM PHOS , KALI PHOS, MAG PHOS, NAT PHOSZettl Health Inc.53e85f92-5863-82f1-e063-6394a90af52e2026-06-10WarningsExact identifier
unii: 91D9GV0Z28
GUNA-AWARENESSBETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -Guna spa10e46b39-7903-4390-b72d-865291245b4c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
Gas ReliefSIMETHICONEAmerisourceBergen (Good Neighbor Pharmacy) 4612233bee4db-d4aa-4c72-8eeb-46ff374a92a62026-06-10WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEP & L Development, LLCf4526eba-e6d0-44de-99ea-4af7a6dba1992026-06-10WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
unii: 92RU3N3Y1O
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
BM BIO15CALC PHOS, KALI PHOS, FERR PHOS, KALI SULPH, MAG PHOSTotal Operations Management LLC DBA:Bestmade Natural Products Micro53d242d4-c900-f0aa-e063-6394a90a80c52026-06-09WarningsExact identifier
unii: 91D9GV0Z28
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d2c34e-fa4d-9240-e063-6294a90a28da2026-06-09WarningsExact identifier
unii: 91D9GV0Z28
BM BIO18CALC FLUOR, CALC SULF, SILICEA.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d3c1d6-d0ba-5ea7-e063-6394a90a02942026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
Tums Chewy Bites with Gas ReliefCALCIUM CARBONATE AND SIMETHICONEHaleon US Holdings LLC6d7be7e4-4bff-4cfd-bbbe-df412ac9db102026-06-09WarningsExact identifier
unii: 92RU3N3Y1O
BM BIO24CAL PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d5058d-861a-9e20-e063-6294a90a164c2026-06-09WarningsExact identifier
unii: 91D9GV0Z28

Reported adverse events (FAERS/openFDA)#

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