DoloDent Toothache
- Product NDC
- 55758-435
- 11-digit product format
- 557580435
- Labeler code
- 55758
- Product ID
- 55758-435_227ba7f7-a051-50ad-e063-6394a90a74d6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Pharmadel LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-07-30
- Substance
- ACETAMINOPHEN; CAFFEINE
- Active strength
- 500; 65 mg/1; mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [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
- DoloDent Toothache
- Brand name suffix
- For adults
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
| CAFFEINE | 65 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 3G6A5W338E |
| Rxcui | 307686 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55758-435-24 | DoloDent ToothacheFor adults | 1 in 1 CARTON | TABLET | 1 | | 5 |
| 55758-435-24 | DoloDent ToothacheFor adults | 24 in 1 BOTTLE | TABLET | 24 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55758-435 | DOLODENT TOOTHACHE FOR ADULTS (ACETAMINOPHEN, CAFFEINE) TABLET [PHARMADEL LLC] | 5 | Current NDC, 2 package rows | 20240922_1e7a0c06-ad3c-b94f-e063-6394a90abab1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55758-435-24 | 55758043524 | 1 BOTTLE in 1 CARTON (55758-435-24) / 24 TABLET in 1 BOTTLE | 1 bottle | 2024-07-30 | No | No | Historical |