Acetaminophen
- Product NDC
- 57344-004
- 11-digit product format
- 573440004
- Labeler code
- 57344
- Product ID
- 57344-004_284cd503-79e7-85a0-e063-6394a90a4783
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- AAA Pharmaceutical, Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-04-13
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- 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
- Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198440 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2d98e390-4f2a-41cc-b307-3d2f6a3700dd | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57344-004-04 | Acetaminophen | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 57344-004-04 | Acetaminophen | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 5 | |
| 57344-004-06 | Acetaminophen | 500 in 1 BOTTLE | TABLET, COATED | 500 | 5 |
DailyMed Socrata Ingredients#
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 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | CVS Pharmacy | b9e5df0e-06d3-6f72-e053-2995a90a2d07 | 2024-12-14 | Warnings | M013 |
| Alka-Seltzer Heartburn and Pain | ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE | Bayer HealthCare LLC. | 2928e140-c868-5bf5-e063-6394a90ab024 | 2024-12-13 | Warnings | M013 |
| foster and thrive pain reliever | ACETAMINOPHEN | Strategic Sourcing Services LLC | b8ee568c-80cf-4e35-865e-35516bdab0fd | 2024-12-13 | Warnings | M013 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strive Pharmaceuticals Inc. | c0de0bd2-4868-46dc-a20f-3ca02caaa26b | 2024-12-11 | Warnings | M013 |
| Rite Aid Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Rite Aid | b4797380-9cef-d640-e053-2a95a90a0665 | 2024-12-11 | Warnings | M013 |
| Top Value Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICAROBONATE | Tower Laboratories Ltd | 44babed8-cf38-1c12-e054-00144ff8d46c | 2024-12-11 | Warnings, Adverse reactions | M013 |
| Best Choice Effervescent Antacid Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Valu Merchandisers Company | b5e2300a-b77b-53cc-e053-2a95a90a7a6e | 2024-12-11 | Warnings | M013 |
| EXTRA STRENGTH Headache Relief geltabs | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strive Pharmaceuticals Inc. | b432771a-4f7d-4d39-a038-d1561d8f6708 | 2024-12-11 | Warnings | M013 |
| Pain Relief Childrens | ACETAMINOPHEN | QUALITY CHOICE (Chain Drug Marketing Association) | 223ffb2b-3ee5-4118-955b-bc4fa4e8a2e6 | 2024-12-10 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | UNFI | e689c9e3-dd4d-c646-e053-2a95a90a4b6a | 2024-12-09 | Warnings | M013 |
| DrKids Childrens Pain and Fever | ACETAMINOPHEN 80MG/PIECE | CalmCo LLC | ff4b0528-39a0-80d5-e053-6394a90a8a83 | 2024-12-07 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 972f09a7-2aa1-4b1b-a6dc-2c4578a07803 | 2024-12-05 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | DISCOUNT DRUG MART | e6feff0a-3347-194d-e053-2a95a90acd20 | 2024-12-05 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | DISCOUNT DRUG MART | e6fee238-0b6f-cb84-e053-2995a90a361b | 2024-12-05 | Warnings | M013 |
| Menstrual Complete Maximum Strength | ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE | L.N.K. International, Inc. | 379ef03c-3b6a-40c3-b736-99f0537d26c8 | 2024-12-05 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | Marc Glassman, Inc. | 43bf297f-2832-424f-a013-4bfa1d6c03e6 | 2024-12-04 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Precision Dose, Inc. | 5a68ab98-720c-479a-a60a-4e594add6c09 | 2024-12-04 | Warnings | M013 |
| HEB Effervescent Pain Relief | ASPIRIN | H. E. BUTT GROCERY COMPANY | 03876c71-60ec-3280-e063-6294a90a62dc | 2024-12-03 | Warnings | M013 |
| Migrafein FORTE | ACETAMINOPHEN, CAFFEINE | OPMX LLC | 028875c9-4129-ce2c-e063-6294a90a26cc | 2024-12-03 | Warnings | M013 |
| Neo-Lubrina Fuerte | ACETAMINOPHEN, CAFFEINE | OPMX LLC | 0288a327-fd4b-1991-e063-6294a90ace50 | 2024-12-03 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 2d98e390-4f2a-41cc-b307-3d2f6a3700dd | 5 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 2d98e390-4f2a-41cc-b307-3d2f6a3700dd | 5 |
| 198440 | APAP 500 MG Oral Tablet | SY | 2d98e390-4f2a-41cc-b307-3d2f6a3700dd | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 57344-004-04 | 57344000404 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-004-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2012-04-13 | 0000-00-00 | No | No | Current |
| 57344-004-06 | 57344000406 | 500 TABLET, COATED in 1 BOTTLE (57344-004-06) | 2024-03-15 | No | No | Current |