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 |
|---|---|---|---|---|---|---|
| Aspirin 81 mg Low Dose | ASPIRIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 23b29044-6389-42ea-839a-5351557a6ce3 | 2026-04-23 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4a70867e-481d-4f01-9da3-d85663a1672e | 2026-04-23 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | United Natural Foods, Inc. dba UNFI | 07edcb31-d31d-4607-98c3-dcb1e062cc70 | 2026-04-22 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | ee50c5ee-1a61-4efc-aca9-42d897d6a3b8 | 2026-04-22 | Warnings | M013 |
| Aspirin | ASPIRIN | CVS PHARMACY | 904a2b21-d911-40c3-9e4b-59543ea5be4f | 2026-04-22 | Warnings | M013 |
| Pamprin Multi-Symptom Maximum Strength | ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE | Focus Consumer Healthcare, LLC | 60b3286d-5698-df50-e053-2991aa0afbe2 | 2026-04-20 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | CVS PHARMACY | af6fe4a9-2d18-4fed-b952-0a7866f65251 | 2026-04-20 | Warnings | M013 |
| Aspirin 81 mg | ASPIRIN | Preferred Pharmaceuticals Inc. | ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e | 2026-04-20 | Warnings | M013 |
| Parry-500mg Acetaminophen | ACETAMINOPHEN | MDC PHARMACEUTICALS LIMITED | fb07ba10-3210-41bc-9310-c952118fdcf3 | 2026-04-17 | Warnings | M013 |
| Aspirin NSAID | ASPIRIN | Valu Merchandisers Company | 0cc46a81-54c9-44b7-b384-79d25255eff2 | 2026-04-17 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Valu Merchandisers Company | 99de2c41-59b0-42e7-847e-e51229c6164f | 2026-04-17 | Warnings | M013 |
| Pain and Fever Childrens | ACETAMINOPHEN | Walgreen Company | 1f3e2895-5ef7-4e6a-8d2e-b805d148f980 | 2026-04-16 | Warnings | M013 |
| Childrens TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | b297aff8-a08b-4d37-b168-800a56564cbd | 2026-04-16 | Warnings | M013 |
| Childrens Tylenol | ACETAMINOPHEN | Kenvue Brands LLC | 9782fe86-d72a-4231-b1ba-d3f3b4ee49e3 | 2026-04-16 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | 8e65478b-7a7b-416c-b8e3-23dad79f8cc1 | 2026-04-16 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Valu Merchandisers Company | c9e384e5-fa9b-4c75-b5e3-16eb8db662ef | 2026-04-16 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | b6abfbbb-9826-4cd6-940f-3a314480a5a5 | 2026-04-15 | Warnings | M013 |
| Good Sense Pain and Fever | ACETAMINOPHEN | L. Perrigo Company | f7137fe6-582e-43a4-8302-90ca54cd1de3 | 2026-04-14 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | e13656eb-513e-411e-bdae-35ff1ba7cfc1 | 2026-04-13 | Warnings | M013 |
| CareOne Acetaminophen | ACETAMINOPHEN | American Sales Company | b4f54465-3232-4685-9570-90be00876577 | 2026-04-12 | 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 |