NDC 35916-1940-01 - Simethicone
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
- 35916-1940
- Requested NDC
- 35916-1940-01
- Package NDCs from labels
- 35916-1940-1, 35916-1940-2, 35916-1940-01
- Manufacturer
- SOFTGEL HEALTHCARE PRIVATE LIMITED
- Effective date
- 2026-10-08
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Simethicone - SOFTGEL HEALTHCARE PRIVATE LIMITED | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2026-10-08 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-1940-1 | Simethicone | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | 3 | |
| 35916-1940-2 | Simethicone | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 3 | |
| 35916-1940-2 | Simethicone | 5 in 1 CARTON | CAPSULE, LIQUID FILLED | 5 | 3 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Equaline Hemorrhoidal | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | United Natural Foods, Inc. dba UNFI | bf87824a-522d-46da-81b6-e30ea11a2235 | 2026-06-11 | Warnings | PDC6A3C0OX |
| Mag-Al Plus | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | Cardinal Health 107, LLC | 08df7403-9ee3-4a43-a151-c1a6ef7a7549 | 2026-06-10 | Warnings | 92RU3N3Y1O |
| BM BM5 DROPS | APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC | BM Private Limited | 53e763ee-9a44-a914-e063-6394a90aeb3c | 2026-06-10 | Warnings | ETJ7Z6XBU4 |
| GUNA-AWARENESS | BETAINE - 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 spa | 10e46b39-7903-4390-b72d-865291245b4c | 2026-06-10 | Warnings | ETJ7Z6XBU4 |
| Gas Relief | SIMETHICONE | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 33bee4db-d4aa-4c72-8eeb-46ff374a92a6 | 2026-06-10 | Warnings | M002 92RU3N3Y1O |
| Gas Relief | SIMETHICONE | P & L Development, LLC | f4526eba-e6d0-44de-99ea-4af7a6dba199 | 2026-06-10 | Warnings | M002 92RU3N3Y1O |
| Medline | DIMETHICONE | Medline Industries, LP | 509ee758-9d53-220c-e063-6394a90a4bd5 | 2026-06-09 | Warnings | 92RU3N3Y1O |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 53d1c51a-77eb-bb3c-e063-6394a90aab3f | 2026-06-09 | Warnings | ETJ7Z6XBU4 |
| BM BIO18 | CALC FLUOR, CALC SULF, SILICEA. | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d3c1d6-d0ba-5ea7-e063-6394a90a0294 | 2026-06-09 | Warnings | ETJ7Z6XBU4 |
| Tums Chewy Bites with Gas Relief | CALCIUM CARBONATE AND SIMETHICONE | Haleon US Holdings LLC | 6d7be7e4-4bff-4cfd-bbbe-df412ac9db10 | 2026-06-09 | Warnings | 92RU3N3Y1O |
| SIMETHICONE | SIMETHICONE | YYBA | 50250112-933c-ffb1-e063-6394a90aaafb | 2026-06-09 | Warnings | M002 92RU3N3Y1O |
| Medline | DIMETHICONE | Medline Industries, LP | 3c448cf7-8ca5-c7f7-e063-6294a90a75ff | 2026-06-08 | Warnings | 92RU3N3Y1O |
| XIMONTH Fungi Free Bee Venom Nail Soothing Serum | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 53bab969-8407-6334-e063-6294a90aa5d1 | 2026-06-08 | Warnings | 059QF0KO0R |
| BM Silicea | SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53bb3927-6053-eb3d-e063-6394a90a5ddf | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| Scrofularoforce | RUMEX 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 VIRGINIANA | BioActive Nutritional, Inc. | 737cd410-0405-41b0-b7f2-29bb20037849 | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| VAX | BAPTISIA 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-a5d4-01b713e6862d | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| Chloraseptic Sore Throat Max | PHENOL AND GLYCERIN | Prestige Brands Holdings, Inc. | 882c940c-b3c3-4aa4-8d64-e4260f066ff4 | 2026-06-08 | Warnings | PDC6A3C0OX |
| Vermex | ARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUM | BioActive Nutritional, Inc. | 6be5fbcf-bb22-4b20-b65a-d943c516adf9 | 2026-06-04 | Warnings | ETJ7Z6XBU4 |
| INFANTS GAS RELIEF | SIMETHICONE | Mollec Inc | 53705dbc-daca-2214-e063-6294a90a1097 | 2026-06-04 | Warnings | M002 92RU3N3Y1O |
| Childrens Simethicone Drops | CHILDRENS SIMETHICONE DROPS | PAI Holdings, LLC dba PAI Pharma | 6e26ffbe-4c5b-4689-99bc-88b39ed40a25 | 2026-06-04 | Warnings | M002 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.