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
- CAFFEINE; ACETAMINOPHEN
- Active strength
- 65; 500 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
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
- DoloDent Toothache
- Brand name suffix
- For adults
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAFFEINE | 65 mg/1 |
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3G6A5W338E | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 307686 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1e7a0c06-ad3c-b94f-e063-6394a90abab1 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| 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#
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 |
|---|---|---|---|---|---|---|
| Pain Relief PM Extra Strength | ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG | Allegiant Health | 423a8445-964c-4cdb-889a-f391ca5253e7 | 2018-12-31 | Warnings | M013 |
| Cold Multi-Symptom Night-time | ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI | Allegiant Health | 3f020cf2-6011-4216-9b39-0b3dc5f0749c | 2018-12-26 | Warnings | M013 |
| Aspirin Chewable | ASPIRIN 81 MG | Allegiant Health | 92b8637b-03a9-461f-b2f6-6eddaa214953 | 2018-12-21 | Warnings | M013 |
| Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Allegiant Health | b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f | 2018-12-21 | Warnings | M013 |
| Clear Choice Regular Strength Pain Reliever | ACETAMINOPHEN | Athlete's Needs, Inc. | d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7 | 2018-12-11 | Warnings | M013 |
| ASPIRIN Enteric Coated | ASPIRIN 81 MG | Allegiant Health | 5910a882-eb40-440f-8a30-c21fbce9050e | 2018-11-07 | Warnings | M013 |
| Aspirin | ASPIRIN 325 MG | Allegiant Health | 88b54062-8b3d-4024-a957-62b3255184b9 | 2018-11-07 | Warnings | M013 |
| Aspirin Enteric Coated | ASPIRIN 81 MG | Allegiant Health | 3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5 | 2018-11-07 | Warnings | M013 |
| Tension Headache Relief | TENSION HEADACHE RELIEF | Allegiant Health | b431a1a3-39c4-4d6c-afdc-c8b017ad89da | 2017-11-16 | Warnings | M013 |
| SED-MAX | ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG | Command Brands, LLC | 4920a0e9-6f88-4df0-8657-77c95a3b9617 | 2017-01-19 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 307686 | acetaminophen 500 MG / caffeine 65 MG Oral Tablet | PSN | 1e7a0c06-ad3c-b94f-e063-6394a90abab1 | 5 |
| 307686 | acetaminophen 500 MG / caffeine 65 MG Oral Tablet | SCD | 1e7a0c06-ad3c-b94f-e063-6394a90abab1 | 5 |
| 307686 | APAP 500 MG / Caffeine 65 MG Oral Tablet | SY | 1e7a0c06-ad3c-b94f-e063-6394a90abab1 | 5 |
Packages#
| 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 | Current |