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 |
|---|---|---|---|---|---|---|
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Proficient Rx LP | af8b30a0-7a56-4557-8404-cc8059fcd6bc | 2023-11-01 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | AMERIFOODS TRADING COMPANY | f6dd387d-c768-9443-e053-6394a90aca14 | 2023-10-31 | Warnings | M013 |
| ASPIRIN | ASPIRIN | AMERIFOODS TRADING COMPANY | f6cec280-17a5-5c5d-e053-6394a90a81aa | 2023-10-31 | Warnings | M013 |
| Regular Strength Aspirin | ASPIRIN | CARDINAL HEALTH, INC. | 8aaa82c6-b46b-25c5-e053-2a95a90a3793 | 2023-10-30 | Warnings | M013 |
| SafeTynadol | ACETAMINOPHEN | Sinew Pharma Inc. | b956d527-7ea7-e084-e053-2a95a90a866d | 2023-10-28 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Magno-Humphries, Inc. | 9d2275c8-0c3d-d2b3-e053-2995a90a368e | 2023-10-27 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Magno-Humphries, Inc. | 9d22bedb-9fb3-8421-e053-2a95a90acf4a | 2023-10-27 | Warnings | M013 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | Magno-Humphries, Inc. | 9d22d642-8aaf-d17e-e053-2995a90ae182 | 2023-10-27 | Warnings | M013 |
| ENTERIC COATED ASPIRIN | ASPIRIN | Magno-Humphries, Inc. | a7c02378-4213-4e57-aca2-2437ad02f786 | 2023-10-27 | Warnings | M013 |
| Extraprin | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Magno-Humphries, Inc. | 9d22cdc8-29c5-4273-e053-2a95a90ad0bf | 2023-10-27 | Warnings | M013 |
| Regular Strength Enteric coated aspirin | ASPIRIN | Geri-Care Pharmaceutical Corp | c321208c-f192-42c5-9454-e0df5d02d685 | 2023-10-26 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALGREENS | f3c69974-7f51-2227-e053-2995a90a5570 | 2023-10-21 | Warnings | M013 |
| Menstrual Complete | MENSTRUAL COMPLETE | Healthlife of USA | c7e89b01-a8eb-4487-8f0b-a4b9ae6d9f33 | 2023-10-21 | Warnings | M013 |
| Extra Strength Pain Relief | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | e65dbd01-2d5e-4067-ad98-98d879cfb5ee | 2023-10-19 | Warnings | M013 |
| Regular Strength Pain Reliever | ACETAMINOPHEN | INGLES MARKETS, INC. | f06fe167-8a16-14d9-e053-2a95a90a1a0f | 2023-10-17 | Warnings | M013 |
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | BLESSINGS INTERNATIONAL | ee8ba190-2c42-7ca2-e053-2a95a90a01a0 | 2023-10-17 | Warnings | M013 |
| Aphen | ACETAMINOPHEN | Asclemed USA, Inc. | fe3c0a2b-316b-4620-b6bc-378dbaf7ed57 | 2023-10-16 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | Walgreens | b4b06d32-6a09-4c43-980b-377b617ba739 | 2023-10-09 | Warnings | M013 |
| FLO PMS Complete | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | O Positiv, Inc. | cce62d9f-adb1-4473-8258-910dff6b1378 | 2023-10-09 | Warnings | M013 |
| childrens mapap | ACETAMINOPHEN | Proficient Rx LP | 88c4183a-3032-46de-bf18-f700055f617b | 2023-10-01 | 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 |