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 |
|---|---|---|---|---|---|---|
| THERASTAT, CHERRY | CHERRY COUGH DROPS | HART Health | e3fdd1de-8f28-4063-a590-6c44507dead1 | 2025-12-23 | Warnings | M |
| Crystal Clean Antibacterial HandSoap | BENZALKONIUM CHLORIDE | Chemcor Chemical Corporation | 308969b5-5ab2-44ef-ac70-9518a5dfbee2 | 2025-12-22 | Warnings | M |
| Foaming Antibacterial Handsoap | BENZALKONIUM CHLORIDE | Chemcor Chemical Corporation | eed9b007-0dc1-4954-891f-a7a042e763aa | 2025-12-22 | Warnings | M |
| Antibacterial Handsoap | BENZALKONIUM CHLORIDE | Chemcor Chemical Corporation | 1022be5e-d515-4a06-bf2b-65774ec29a0b | 2025-12-22 | Warnings | M |
| Healthy Hands Foaming Hand Sanitizer | N/A | Maintex | 746650b8-74b7-43f0-bdfc-62a68764f936 | 2025-12-22 | Warnings | M |
| Chemcor Chemical Foaming Hand Sanitizer | BENZALKONIUM CHLORIDE | Chemcor Chemical Corporation | 5c9d90c1-0381-4237-9529-398fa51b3ab4 | 2025-12-22 | Warnings | M |
| Fresh Hands | BENZALKONIUM CHLORIDE | Maintex | e174083a-8820-4fa7-8cc2-0a2c86f27cd6 | 2025-12-22 | Warnings | M |
| Aluminum Hydroxide | ALUMINUM HYDROXIDE | ATLANTIC BIOLOGICALS CORP. | 60a54d4e-89c2-4329-86bf-a288527f37b5 | 2025-12-15 | Warnings | M |
| MAX relief junior | ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | ff1f6f82-0c7c-4e3f-a2bd-3185e16fa770 | 2025-12-10 | Warnings | M |
| Health One Pain Relief Cream with Lidocaine 4% | PAIN RELIEF CREAM WITH LIDOCAINE 4% | ONE2ZEE LIMITED LIABILITY COMPANY | 46a2276f-9da0-4e41-92f0-b17c302c7222 | 2025-12-03 | Warnings | M |
| Health One Deep Relieving Gel | DEEP RELIEVING GEL | ONE2ZEE LIMITED LIABILITY COMPANY | 41d837f1-09e4-4ce3-8c1a-725c2147c7de | 2025-12-03 | Warnings | M |
| Hand Sanitizer | ANTISEPTIC GEL | HART Health | 87fcd27f-e4bf-4ae9-ad2e-b9b11ac554cc | 2025-12-02 | Warnings | M |
| AB 3000 | BENZALKONIUM CHLORIDE | Chemco | 892c8911-9f1a-4c0c-9106-6d9a90d577a9 | 2025-11-06 | Warnings | M |
| Strike Bac Antibacterial Hand | BENZALKONIUM CHLORIDE | Genlabs Corporation | 4014aa67-8016-40c5-88ec-daec9dba4f45 | 2025-11-06 | Warnings | M |
| Metro Antimicrobial Hand | BENZALKONIUM CHLORIDE | Maintex | a84d83dd-2445-4d0f-b763-2c69e8248cf9 | 2025-11-06 | Warnings | M |
| Butler Clean Hands | BENZALKONIUM CHLORIDE | Maintex | 3fd526a8-d197-4a12-b51b-165e706720a7 | 2025-11-06 | Warnings | M |
| First Street Dishwashing Concentrate and Antibacterial Hand | BENZALKONIUM CHLORIDE | Amerifoods Trading Company | fc81ef1a-db55-411e-8b25-7dd59dd38eda | 2025-11-06 | Warnings | M |
| Champion Ultra Clean | BENZALKONIUM CHLORIDE | Maintex | 47426f67-af14-4b42-8ada-11b364826949 | 2025-11-06 | Warnings | M |
| Premium Protection Antibacterial Hand | BENZALKONIUM CHLORIDE | Maintex | 53bd6860-dde3-4525-ba1b-50f69be09abc | 2025-11-06 | Warnings | M |
| Hy-G-Clenz | BENZALKONIUM CHLORIDE | Micronova Manufacturing, Inc. | ce96634e-1ce8-4244-b317-8e1da249de83 | 2025-11-06 | 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 |