SEDAL3X
- Product NDC
- 69729-055
- 11-digit product format
- 697290055
- Labeler code
- 69729
- Product ID
- 69729-055_1a161b94-99d7-840a-e063-6394a90acc00
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin, Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-09-07
- Substance
- ACETAMINOPHEN; ASPIRIN; CAFFEINE
- Active strength
- 250; 250; 65 mg/1; mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SEDAL3X
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 250 mg/1 |
| ASPIRIN | 250 mg/1 |
| CAFFEINE | 65 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, R16CO5Y76E, 3G6A5W338E |
| Rxcui | 308297 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69729-055-40 | SEDAL3X | 40 in 1 BOTTLE | TABLET | 40 | | 3 |
| 69729-055-40 | SEDAL3X | 1 in 1 CARTON | TABLET | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69729-055 | SEDAL3X (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [OPMX LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240606_e9089f8b-3d23-5c81-e053-2995a90a4202.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69729-055-40 | 69729005540 | 1 BOTTLE in 1 CARTON (69729-055-40) / 40 TABLET in 1 BOTTLE | 1 bottle | 2022-09-07 | 0000-00-00 | No | No | Current |