NDC 35916-1938-01 - 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
- 35916-1938
- Requested NDC
- 35916-1938-01
- Package NDCs from labels
- 35916-1938-1, 35916-1938-2, 35916-1938-3, 35916-1938-01
- Manufacturer
- Softgel Healthcare Pvt Ltd
- 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 Pvt Ltd | Softgel Healthcare Pvt Ltd | 2026-10-08 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-1938-1 | Simethicone | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | 4 | |
| 35916-1938-2 | Simethicone | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | 4 | |
| 35916-1938-3 | Simethicone | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 4 | |
| 35916-1938-3 | Simethicone | 1500 in 1 BAG | CAPSULE, LIQUID FILLED | 1500 | 4 |
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 |
|---|---|---|---|---|---|---|
| HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN | ZINC OXIDE,TITANIUM DIOXIDE | Guangzhou Tata Biotechnology Co., Ltd. | 4339df13-77d3-31a1-e063-6394a90a5208 | 2026-08-17 | Warnings | 15FIX9V2JP |
| Cerebellum Thalamus A Aurm | CEREBELLUM THALAMUS A AURUM | Uriel Pharmacy Inc. | e1c395b8-9221-401f-8980-c91ff8843458 | 2026-08-17 | Warnings | ETJ7Z6XBU4 |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | HAMBLIN DERMATOLOGY | 5942e64c-416e-7525-e063-6394a90a2839 | 2026-08-17 | Warnings | 15FIX9V2JP |
| Protect Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | Opal Day Spa | 5943413a-48e1-0bdf-e063-6294a90a2fff | 2026-08-17 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | MedSpa By Beauty Bar LLC | 5943ba3d-688e-9e9c-e063-6294a90afa9a | 2026-08-17 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | CORBY, JR., TERRY L. | 594443fd-8e27-4ec6-e063-6294a90a3ff0 | 2026-08-17 | Warnings | 15FIX9V2JP |
| Leader Dry Eye Relief Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | CARDINAL HEALTH 110, LLC. DBA LEADER | 2ded4bda-b3c3-4521-8701-5c8446fd148b | 2026-08-17 | Warnings | PDC6A3C0OX |
| CVS Health Infant Gas Relief | SIMETHICONE | CVS PHARMACY | 088993c1-31f0-4270-a3df-a585e7c8d511 | 2026-08-17 | Warnings | M002 92RU3N3Y1O |
| Mylanta Fall Harvest Collection Spiced Apple Cider | CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE | Infirst Healthcare Inc. | 5a6040ff-1779-3215-e063-6294a90aaab1 | 2026-08-15 | Warnings | 92RU3N3Y1O |
| Mylanta Fall Harvest Collection Pumpkin Spice | CALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONE | Infirst Healthcare Inc. | 5a60a221-5b37-806e-e063-6394a90a5ccc | 2026-08-15 | Warnings | 92RU3N3Y1O |
| BM BM63 DROPS | CEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADEN | BM Private Limited | 59006d82-610a-2e08-e063-6394a90af1ed | 2026-08-14 | Warnings | 059QF0KO0R |
| BM BM134 DROPS | ARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEA | BM Private Limited | 59023500-89be-cc76-e063-6294a90a6e02 | 2026-08-14 | Warnings | ETJ7Z6XBU4 |
| BM BM164 DROPS | ARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUM | BM Private Limited | 5902770f-eb01-d099-e063-6394a90ad3eb | 2026-08-14 | Warnings | PDC6A3C0OX |
| BM BM173 DROPS | ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA UREN | BM Private Limited | 59036ca4-e7bb-bbe7-e063-6394a90a410a | 2026-08-14 | Warnings | ETJ7Z6XBU4 |
| CVS PHARMACY Extra Strength Gas Relief | SIMETHICONE ANTIGAS | CVS | b0fc2f24-cd63-4bb2-b9bb-a73449bcc169 | 2026-08-13 | Warnings | M002 92RU3N3Y1O |
| CVS PHARMACY Extra Strength | SIMETHICONE | CVS | 98db6216-897c-4cf6-a4b7-b913ae3a2496 | 2026-08-13 | Warnings | M002 92RU3N3Y1O |
| CVS PHARMACY Gas relief | SIMETHICONE | CVS | c2a3a978-c957-4453-88b3-53f4e80a2465 | 2026-08-13 | Warnings | M002 92RU3N3Y1O |
| Adaptopath | ADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUM | Energetix Corporation | 41234598-0cb5-41c2-bfbe-1c15ee9bf502 | 2026-08-11 | Warnings | ETJ7Z6XBU4 |
| Agri-Chord | ARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOS | Energetix Corporation | 9eb50e9a-3528-4809-bd76-47d99ef03f0e | 2026-08-11 | Warnings | ETJ7Z6XBU4 |
| Drainage-Tone | CALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS. | Energetix Corporation | 296b455e-27c5-4f6e-929d-c4ee75b7fb0e | 2026-08-11 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.