Simethicone
- Product NDC
- 71610-607
- 11-digit product format
- 716100607
- Labeler code
- 71610
- Product ID
- 71610-607_57e89b75-97c2-f188-e063-6294a90a6cc6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- M002
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-03-01
- Substance
- DIMETHICONE
- Active strength
- 80 mg/1
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Simethicone
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 80 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 314216 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| da0cc98e-1692-405a-ab81-420d6f9df6de | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71610-607-04 | Simethicone | 4 in 1 BOTTLE | TABLET, CHEWABLE | 4 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71610-607-04 | EA - Each | 71610-607 | f832fb39-307f-4d6a-a612-8a63bf7ec358 | 1 | 2021-12-08 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| INFANTS GAS RELIEF DROPS | SIMETHICONE | RELIABLE 1 LABORATORIES | b479bf22-3469-7916-e053-2995a90addc8 | 2026-07-30 | Warnings | M002 |
| Best Choice | SIMETHICONE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 245504a6-d2fc-4e05-871b-bab03f34e154 | 2026-07-17 | Warnings | M002 |
| Best Choice Extra Strength | SIMETHICONE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | a41b2895-abbe-4cf1-9c42-0b5e902d298b | 2026-07-17 | Warnings | M002 |
| FEVIA Gas Control | SIMETHICONE | VIVUNT PHARMA LLC | 4bd53a70-3ba0-364c-e063-6394a90a7a64 | 2026-07-16 | Warnings | M002 |
| FEVIA Gas Control | SIMETHICONE | VIVUNT PHARMA LLC | 4b1d1bce-eeef-b790-e063-6294a90a166e | 2026-07-16 | Warnings | M002 |
| Maximum Strength Antacid Mint | SIMETHICONE | Guardian Drug Company | 48ec3132-17cf-1de9-e063-6294a90aa407 | 2026-07-14 | Warnings | M002 |
| Gas Relief | SIMETHICONE | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | cce7f7db-99b8-4d7d-ac77-43da6323ebe1 | 2026-07-14 | Warnings | M002 |
| Gas Relief | SIMETHICONE | Rite Aid Corporation | 43e94ffc-a3ec-4a16-98db-b000a6dc4230 | 2026-07-10 | Warnings | M002 |
| Tea Tree Oil Antifungal | TOLNAFTATE | Guangzhou ChuanMa International Trading Co.,Ltd. | 55a48fc6-1963-66ea-e063-6294a90a3501 | 2026-07-02 | Warnings | M002 |
| RIGHT REMEDIES Extra Strength Gas Relief | SIMETHICONE | Strive Pharmaceuticals Inc. | 2d651784-a17b-12bc-e063-6294a90a8ab2 | 2026-06-30 | Warnings | M002 |
| Gas Relief | GAS RELIEF | Chain Drug Marketing Association, Inc. | 912f896b-ff49-40e6-b425-c314e0cbf48e | 2026-06-30 | Warnings | M002 |
| Gas Relief | SIMETHICONE | Strategic Sourcing Services LLC | 0add7687-f9d7-4f70-b9a8-1454db8a7caf | 2026-06-29 | Warnings | M002 |
| Gas Relief Extra Strength | SIMETHICONE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 447ee411-f4b9-4dd1-a3e0-36ad79bccbf9 | 2026-06-25 | Warnings | M002 |
| Gas Relief | SIMETHICONE | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 33bee4db-d4aa-4c72-8eeb-46ff374a92a6 | 2026-06-10 | Warnings | M002 |
| Gas Relief | SIMETHICONE | P & L Development, LLC | f4526eba-e6d0-44de-99ea-4af7a6dba199 | 2026-06-10 | Warnings | M002 |
| SIMETHICONE | SIMETHICONE | YYBA | 50250112-933c-ffb1-e063-6394a90aaafb | 2026-06-09 | Warnings | M002 |
| INFANTS GAS RELIEF | SIMETHICONE | Mollec Inc | 53705dbc-daca-2214-e063-6294a90a1097 | 2026-06-04 | Warnings | M002 |
| Childrens Simethicone Drops | CHILDRENS SIMETHICONE DROPS | PAI Holdings, LLC dba PAI Pharma | 6e26ffbe-4c5b-4689-99bc-88b39ed40a25 | 2026-06-04 | Warnings | M002 |
| Infants Simethicone Drops | INFANTS SIMETHICONE DROPS | PAI Holdings, LLC dba PAI Pharma | 235f458e-c275-4bc1-9c0f-e007c4040649 | 2026-06-03 | Warnings | M002 |
| Gas Relief Extra Strength | SIMETHICONE | Care One (Retail Business Services, LLC.) | 5e2b25a0-eddf-4d58-927f-bc72c0a92c88 | 2026-06-02 | Warnings | M002 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314216 | simethicone 80 MG Chewable Tablet | PSN | da0cc98e-1692-405a-ab81-420d6f9df6de | 3 |
| 314216 | simethicone 80 MG Chewable Tablet | SCD | da0cc98e-1692-405a-ab81-420d6f9df6de | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71610-607-02 | 71610060702 | 2 TABLET, CHEWABLE in 1 BOTTLE (71610-607-02) | 2026-07-28 | No | No | Current | |
| 71610-607-04 | 71610060704 | 4 TABLET, CHEWABLE in 1 BOTTLE (71610-607-04) | 2021-10-25 | 0000-00-00 | No | No | Current |