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 |
|---|---|---|---|---|---|---|
| IMODIUM Multi-Symptom Relief | LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE | Kenvue Brands LLC | ecb91e47-2b0c-47c8-9256-4623d8bc825e | 2026-08-25 | Warnings | 92RU3N3Y1O |
| Q Skin Science | SUNSCREEN | International Cosmeceuticals, Inc | 59e4c3d0-ee4c-2350-e063-6394a90ac9d2 | 2026-08-25 | Warnings | 15FIX9V2JP |
| Gas Relief | SIMETHICONE | Rugby Laboratories | 9353633b-5718-4366-a943-d49b8076256c | 2026-08-24 | Warnings | M002 92RU3N3Y1O |
| Claravie | DIMETHICONE | Gentell LLC | 59c6da39-b5f1-8253-e063-6394a90a0e8f | 2026-08-24 | Warnings | 92RU3N3Y1O |
| MELAO zinc stick(GREEN) | TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE | Guangzhou Haishi Biological Technology Co., Ltd. | 59c70c82-f7ff-9a04-e063-6294a90a7b3d | 2026-08-24 | Warnings | 15FIX9V2JP |
| Sterile Water | WATER | REMEDYREPACK INC. | 5dd5d148-6e23-41de-bff5-551b2aea9598 | 2026-08-24 | Warnings, Adverse reactions | 059QF0KO0R |
| Medline | DIMETHICONE | Medline Industries, LP | 0d94fd18-a120-e171-e063-6394a90ae9c0 | 2026-08-24 | Warnings | 92RU3N3Y1O |
| SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01 | ZINC OXIDE, TITANIUM DIOXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 59d74e3f-e3fa-a7a9-e063-6294a90a76e5 | 2026-08-24 | Warnings | 15FIX9V2JP |
| Aging Eye Formula | CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUM | Nutritional Specialties, Inc. | d5b44f79-5299-4b31-ba45-0e511cdbe17c | 2026-08-24 | Warnings | ETJ7Z6XBU4 |
| Claravie | ZINC OXIDE, DIMETHICONE | Gentell LLC | 598a5c0b-1e2f-1335-e063-6394a90ac4f4 | 2026-08-21 | Warnings | 92RU3N3Y1O |
| HyVee Ultra Strength Gas Relief SOFTGEL | SIMETHICONE | HyVee Inc | 49808dc8-a26e-49f4-e063-6294a90a4796 | 2026-08-21 | Warnings | M002 92RU3N3Y1O |
| Mederma PM | DIMETHICONE | L Perrigo Company | 8c728904-28f4-4333-a9ea-20996fd1b007 | 2026-08-21 | Warnings | 92RU3N3Y1O |
| HyVee Extra Strength Gas Relief SOFTGEL | SIMETHICONE | HyVee Inc | 496dd780-fe7c-ced6-e063-6294a90aa598 | 2026-08-21 | Warnings | M002 198852 92RU3N3Y1O |
| Bio Combination 28 | SCHUESSLER SALTS | LDD Bioscience Private Limited | 597caf33-5107-9dec-e063-6294a90a5fcd | 2026-08-20 | Warnings | ETJ7Z6XBU4 |
| Sweat Resistant Sunscreen Body Original | TITANIUM DIOXIDE, ZINC OXIDE | Clutch, Inc. | 4bbde755-e312-123e-e063-6294a90a467f | 2026-08-20 | Warnings | 15FIX9V2JP |
| Psorinum Complex | PHOSPHORUS, SILICEA, SULPHUR, ALOE | BioActive Nutritional, Inc. | d4746927-e6d4-463d-a084-56ffc48d1e67 | 2026-08-20 | Warnings | ETJ7Z6XBU4 |
| Boneforce HP | CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALE | BioActive Nutritional, Inc. | d96ca52b-781d-431c-ad2a-a54fd57eb106 | 2026-08-20 | Warnings | ETJ7Z6XBU4 |
| Mag-AL Plus | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE | PAI Holdings, LLC dba PAI Pharma | 896ab07a-1b40-43ab-8589-3be86b1c4198 | 2026-08-19 | Warnings | 92RU3N3Y1O |
| Claravie Skin Repair Cream | DIMETHICONE | Gentell LLC | 596ae269-172e-aef5-e063-6394a90a4e2a | 2026-08-19 | Warnings | 92RU3N3Y1O |
| CVS Health Anti gas | SIMETHICONE | CVS PHARMACY | 352b1d0e-c6dc-491e-b3e2-c3d9dac3213b | 2026-08-17 | Warnings | M002 92RU3N3Y1O |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.