Topcare Migraine Relief
- Product NDC
- 36800-533
- 11-digit product format
- 368000533
- Labeler code
- 36800
- Product ID
- 36800-533_f175024c-e8d0-4cb8-8124-fe2a64f0d85d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin, Caffeine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA075794
- Marketing category
- ANDA
- Marketing start
- 2018-07-20
- 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
- Topcare Migraine Relief
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-533-62 | Topcare Migraine Relief | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 36800-533-62 | Topcare Migraine Relief | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | | 5 |
| 36800-533-78 | Topcare Migraine Relief | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 36800-533-78 | Topcare Migraine Relief | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-533 | TOPCARE MIGRAINE RELIEF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20230510_a2a9fbec-639f-4002-aa34-51b4563fc38e.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 |
|---|
| 36800-533-62 | 36800053362 | 1 BOTTLE in 1 CARTON (36800-533-62) / 24 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2018-07-20 | 0000-00-00 | No | No | Current |
| 36800-533-78 | 36800053378 | 1 BOTTLE in 1 CARTON (36800-533-78) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2018-07-20 | 0000-00-00 | No | No | Current |