Simethicone 125MG Gas Relief
- Product NDC
- 55629-021
- 11-digit product format
- 556290021
- Labeler code
- 55629
- Product ID
- 55629-021_84fec012-9895-4286-af72-d08b054837d5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Simethicone 125 mg
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- One2Zee Limited Liability Company
- Application
- M
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-09-05
- Substance
- DIMETHICONE
- Active strength
- 125 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 125MG Gas Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIMETHICONE | 125 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92RU3N3Y1O | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198852 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0df348bf-5a07-4f36-ae70-ca2961a9ce7e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55629-021-01 | Simethicone 125MG Gas Relief | 365 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 365 | 1 |
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 |
|---|---|---|---|---|---|---|
| First Street Antibacterial Liquid Hand | BENZALKONIUM CHLORIDE | Amerifoods Trading Company | e9d5fefa-970b-42ba-8139-18e564415344 | 2025-11-06 | Warnings | M |
| Cetirza | CETIRIZINE HCL | HART Health | 44b22f6f-5731-4dfe-af33-4e4e54fc3af5 | 2025-10-06 | Warnings | M |
| Dolce and Gabbana Blueberry Nutri Tint SPF 20 6W Light | ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | d2930d0e-c622-4843-87f2-fa1a92837ff2 | 2025-09-05 | Warnings | M |
| Alcohol | ISOPROPYL ALCOHOL | NorMed | 959815e5-a73b-4905-9d7d-904b33498386 | 2025-08-15 | Warnings | M |
| TRIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | HART Health | c1903b9f-390a-4756-800c-fd93be4182e3 | 2025-08-13 | Warnings, Adverse reactions | M |
| THERASTAT | CHERRY COUGH DROPS | HART Health | 96bae19a-3337-4199-9b8c-cdf9b368178b | 2025-08-04 | Warnings | M |
| Docu Liquid | DOCUSATE SODIUM | ATLANTIC BIOLOGICALS CORP. | f4ed0721-3be9-4108-a6c9-dbbe115249e9 | 2025-07-31 | Warnings | M |
| MINTOX MAXIMUM STRENGTH | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | ATLANTIC BIOLOGICALS CORP. | ac6a47e7-972f-4b82-96da-89926d345e9f | 2025-07-31 | Warnings | M |
| SENNA | SENNA | ATLANTIC BIOLOGICALS CORP. | 8b7cc0d5-029b-43f7-a050-8771e7db4551 | 2025-07-31 | Warnings | M |
| Stimulant Laxative Plus Stool Softener | DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG | ATLANTIC BIOLOGICALS CORP. | 4c02fcec-6bb7-4497-96c5-0d809209dd17 | 2025-06-27 | Warnings | M |
| Orythia Pain Relieving Lidocaine | LIDOCAINE | Planet (Anhui) Pharmaceutical Co., Ltd. | d658d495-dd2c-40b7-9446-6f10040ed55e | 2025-06-27 | Warnings | M |
| Bonica EaseX Pain Relieving | CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE | Planet (Anhui) Pharmaceutical Co., Ltd. | 34f1196a-fda1-4bef-be71-e5a09ee97bc1 | 2025-06-27 | Warnings | M |
| Regular Strength Enteric coated aspirin | ASPIRIN | ATLANTIC BIOLOGICALS CORP. | e1c8d0ed-da1d-4b1a-9a85-7b8532775f87 | 2025-06-24 | Warnings | M |
| Aspirin Low Dose Chewable Orange | ASPIRIN | ATLANTIC BIOLOGICALS CORP. | a0d8ee59-1ce0-4ddd-a90c-54adb512540c | 2025-06-24 | Warnings | M |
| Cepacol Extra Strength Sore Throat honey lemon | BENZOCAINE AND MENTHOL | ATLANTIC BIOLOGICALS CORP. | 08160ced-e19b-443e-ab16-0d3e4ae8a8ab | 2025-06-24 | Warnings | M |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | HART Health | f50af223-ba83-458a-a557-1ba5dc221a9c | 2025-06-10 | Warnings | M |
| Pharbetol Regular strength | ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | 05a91d24-b498-4ba2-a275-68b871cf62d2 | 2025-06-05 | Warnings | M |
| TEENY TUMMY Gas Relief Drops | SIMETHICONE | ATLANTIC BIOLOGICALS CORP | 376660a2-becb-48cf-a9f5-6a76a8b8ca70 | 2025-05-30 | Warnings | M |
| Mineral Oil | MINERAL OIL | ATLANTIC BIOLOGICALS CORP. | 960502ae-2468-406e-8799-cacb01f2727e | 2025-05-23 | Warnings | M |
| Stomach Relief Regular Strength | BISMUTH SUBSALICYLATE | ATLANTIC BIOLOGICALS CORP. | 5c02d0ba-91e4-4bd2-ac66-6905323653b2 | 2025-05-12 | Warnings | M |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198852 | simethicone 125 MG Oral Capsule | PSN | 0df348bf-5a07-4f36-ae70-ca2961a9ce7e | 1 |
| 198852 | simethicone 125 MG Oral Capsule | SCD | 0df348bf-5a07-4f36-ae70-ca2961a9ce7e | 1 |
| 198852 | dimethicone 125 MG Oral Capsule | SY | 0df348bf-5a07-4f36-ae70-ca2961a9ce7e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 55629-021-01 | 55629002101 | 365 CAPSULE, LIQUID FILLED in 1 BOTTLE (55629-021-01) | 2026-09-05 | No | No | Current |