Dolex
- Product NDC
- 55758-026
- 11-digit product format
- 557580026
- Labeler code
- 55758
- Product ID
- 55758-026_12dcac76-11bc-2c3b-e063-6394a90a35c6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Pharmadel LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-01-01
- Substance
- ACETAMINOPHEN
- Active strength
- 160 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Dolex
- Brand name suffix
- Children Pain and Fever
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 160 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 307668 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f9158463-aeb1-5de0-e053-6294a90a748b | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55758-026-04 | DolexChildren Pain and Fever | 1 in 1 BOX | SUSPENSION | 1 | 3 | |
| 55758-026-04 | DolexChildren Pain and Fever | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 3 |
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 |
|---|---|---|---|---|---|---|
| Pharbetol | ACETAMINOPHEN | Proficient Rx LP | 9c7d65e4-df2f-47c1-a185-66aaf19aad2b | 2024-02-01 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | Proficient Rx LP | 57e4820c-b4eb-442e-9c49-93eedfbc5e5e | 2024-02-01 | Warnings | M013 |
| good sense aspirin | ASPIRIN | Proficient Rx LP | 73013074-9c6e-43c7-acde-4d9d8ed0133d | 2024-02-01 | Warnings | M013 |
| MEDIQUE APAP Extra Strength | ACETAMINOPHEN | Proficient Rx LP | c466a07f-2339-4cf5-8377-e0f109649c52 | 2024-02-01 | Warnings | M013 |
| Percogesic Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE | Medtech Products Inc. | 2c5f1140-fb83-42c9-b0b1-5e2bd69340bb | 2024-02-01 | Warnings | M013 |
| aspirin | ASPIRIN | Proficient Rx LP | 3c7783a7-2b28-4968-b766-0a49dc70ce6d | 2024-02-01 | Warnings | M013 |
| Regular Strength Pain Relief | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 102bdcde-cb90-f248-e063-6394a90aac79 | 2024-01-30 | Warnings | M013 |
| Excedrin Extra Strength Headache | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE | Haleon US Holdings LLC | 61802b27-c9ec-4386-9d44-45e8b1e558b7 | 2024-01-28 | Warnings | M013 |
| AGRIFEN | ACETAMINOPHEN, ASPIRIN, CAFFEINE | OPMX LLC | 0fde22da-cdfc-36cc-e063-6294a90a3885 | 2024-01-26 | Warnings | M013 |
| DOLODOL | ACETAMINOPHEN, ASPIRIN, CAFFEINE | OPMX LLC | e80536f1-92cc-5bb3-e053-2995a90a9540 | 2024-01-26 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | Bryant Ranch Prepack | d913d11f-c7a1-49d2-a2d3-9a29fc032806 | 2024-01-18 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | Bryant Ranch Prepack | 64c28b38-23bb-4c7e-9c19-1d1f0d597528 | 2024-01-18 | Warnings | M013 |
| Buscapina | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | OPMX LLC | e0dd4c04-6811-38a1-e053-2995a90aa3c9 | 2024-01-17 | Warnings | M013 |
| Regular Strength Acetaminophen | ACETAMINOPHEN | CARDINAL HEALTH | bdf8c511-ce25-0e30-e053-2a95a90a33f6 | 2024-01-10 | Warnings | M013 |
| Extra Strength Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2560126e-a54a-4a47-9631-a1bca42f5277 | 2024-01-10 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | A-S Medication Solutions | ee4451c9-4d0f-4373-8f64-fcc1f9dd5856 | 2024-01-05 | Warnings | M013 |
| Pharbetol | ACETAMINOPHEN | Proficient Rx LP | 51ba690e-d76b-41c6-a083-8bc803e1faa2 | 2024-01-01 | Warnings | M013 |
| MEDI-FIRST Non-Aspirin Extra Strength | ACETAMINOPHEN | Proficient Rx LP | 9071b047-5463-4f65-b775-bfb0ce066527 | 2024-01-01 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | TIME CAP LABORATORIES, INC | 1acc8c1a-c746-4635-800c-de1ad758fce0 | 2023-12-30 | Warnings | M013 |
| MAX Cold, Flu, and Sore Throat | ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL | H E B | 9b09b660-0758-48dc-84c9-26cdd2aacc03 | 2023-12-29 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | f9158463-aeb1-5de0-e053-6294a90a748b | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55758-026-04 | 55758002604 | 1 BOTTLE in 1 BOX (55758-026-04) / 118 mL in 1 BOTTLE | 1 bottle | 2023-01-01 | No | No | Current |