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 |
|---|---|---|---|---|---|---|
| Childrens Pain Relief Dye free | ACTEMINOPHEN | BETTER LIVING BRANDS LLC. | 41f504d1-29c4-f075-e063-6394a90ad64c | 2026-04-11 | Warnings | M013 |
| Dr. Simi Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Farmacias De Similares TX LLC | 4f1e1f1a-44f4-2356-e063-6294a90a8cdd | 2026-04-10 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | Akron Pharma Inc. | e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed | 2026-04-10 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | Akron Pharma Inc. | 28413cb3-22c4-40e2-ad6b-42beb438dea3 | 2026-04-10 | Warnings | M013 |
| Pain Reliever Childrens | ACETAMINOPHEN | H E B | 7e43de11-d20b-4920-a04d-3c1b5d35e005 | 2026-04-09 | Warnings | M013 |
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Navajo Manufacturing Company Inc. | f7e572e9-82a7-2127-e053-6394a90ab01a | 2026-04-08 | Warnings | M013 |
| Bayer Genuine Aspirin | ASPIRIN | Navajo Manufacturing Company Inc. | f6f2ce71-5728-aefb-e053-6394a90a20e4 | 2026-04-08 | Warnings | M013 |
| Midol | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | Navajo Manufacturing Company Inc. | cabd10f2-a91e-4406-9249-915e306c867b | 2026-04-08 | Warnings | M013 |
| Aspirin | ASPIRIN | HyVee Inc | 3730ee46-b241-44eb-94fa-52b9d12a9c35 | 2026-04-08 | Warnings | M013 |
| Aspirin | ASPIRIN | Walgreen Company | 82cc404b-fcf5-4e48-ab1a-09d8c47f9e04 | 2026-04-08 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | 9efcce86-dd57-4ea2-ad31-d2038eb61bf1 | 2026-04-07 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 1b164780-ec84-4187-8afa-6f8a0da550fc | 2026-04-07 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 201b860d-dc3c-4380-affa-e757bf2103cf | 2026-04-07 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Walgreens | 6e7475e2-81a9-43b5-9b81-b58ab761a6f4 | 2026-04-07 | Warnings | M013 |
| Pain Relief Aspirin Low Dose | ASPIRIN | Rite Aid Corporation | 503408ed-e799-48a0-8d38-3034f4a0ead5 | 2026-04-02 | Warnings | M013 |
| Aspirin 81 mg | ASPIRIN | Lidl US LLC | 468f4a2f-60f7-4808-95d7-a00be1bb112f | 2026-04-02 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | Grocery Outlet, Inc. | 44de6f5a-0b5c-6c28-e063-6394a90a7e0b | 2026-04-02 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | ARMY AND AIR FORCE EXCHANGE SERVICE | 26ae0d0a-34c0-4d16-951a-8d5a463c808b | 2026-04-02 | Warnings | M013 |
| Pain Reliever plus Sleep Aid NightTime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Kroger Company | 286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d0 | 2026-04-02 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | COSTCO WHOLESALE CORPORATION | c8a8986b-1ab4-9da0-71da-42595db08b44 | 2026-04-02 | 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 |