acetaminophen
- Product NDC
- 68071-3437
- 11-digit product format
- 680713437
- Labeler code
- 68071
- Product ID
- 68071-3437_575e7de2-8194-8e73-e063-6394a90a1d8b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-07-26
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- 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
- acetaminophen
- Listing expiration
- 2027-12-31
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 |
|---|---|
| fdb7331a-d029-8b2a-e053-6294a90adfcd | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3437-1 | acetaminophen | 120 in 1 BOTTLE | TABLET | 120 | 4 | |
| 68071-3437-2 | acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | 4 | |
| 68071-3437-5 | acetaminophen | 45 in 1 BOTTLE | TABLET | 45 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3437 | ACETAMINOPHEN TABLET [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 3 package rows | 20240815_fdb7331a-d029-8b2a-e053-6294a90adfcd.zip |
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 500 MG | ACETAMINOPHEN | A-S Medication Solutions | 92559d65-f5e2-4054-9763-b9c560452dab | 2026-05-22 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Grocery Outlet, Inc. | 441d2629-3fff-0bf1-e063-6394a90aa9b6 | 2026-05-21 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Grocery Outlet, Inc. | 441d1bde-d677-fab7-e063-6394a90aaad4 | 2026-05-21 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Grocery Outlet, Inc. | 441d3a39-cc55-3c7c-e063-6394a90ad7a7 | 2026-05-21 | Warnings | M013 |
| INFANTS Pain and Fever | ACETAMINOPHEN | Aurohealth LLC | b3f57af5-661f-4534-9eed-76e431f338db | 2026-05-20 | Warnings | M013 |
| Good Sense aspirin | ASPIRIN | L. Perrigo Company | e150dd59-8db8-449f-9c9a-1aa6deb3be2e | 2026-05-20 | Warnings | M013 |
| Infants Pain and Fever | ACETAMINOPHEN | Aurohealth LLC | e837538d-0515-4f99-b04c-fda63b28777e | 2026-05-20 | Warnings | M013 |
| Walgreens Headache Relief Extra Strength | ACETAMINOPHEN 250MG, ASPIRIN 250MG AND CAFFEINE 65MG | Walgreens | 52109b65-3bf1-de38-e063-6394a90a9727 | 2026-05-18 | Warnings | M013 |
| Genexa Infants Pain and Fever | ACETAMINOPHEN | Genexa Inc. | 5220a40d-4a4f-5bad-e063-6394a90a93b0 | 2026-05-18 | Warnings | M013 |
| childrens Pain and Fever | ACETAMINOPHEN | Topco Associates, LLC | 7f7b4377-9b40-4a12-808b-f1cd7d241b0d | 2026-05-18 | Warnings | M013 |
| Aspirin Enteric Coated, Regular Strength | ASPIRIN | Gendose Pharmaceuticals, LLC | 10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa | 2026-05-15 | Warnings | M013 |
| Aspirin | ASPIRIN | Gendose Pharmaceuticals, LLC | 119de26f-cce5-401c-81fa-775ebebf6c6f | 2026-05-15 | Warnings | M013 |
| Aspirin Low Dose Chewable Orange | ASPIRIN | Cardinal Health 107, LLC | 827bbe77-febb-4352-892f-3fbb2acfc7d5 | 2026-05-14 | Warnings | M013 |
| Aspirin | ASPIRIN | Topco Associates, LLC | 56c125de-fabf-41fa-88a4-760d2793f202 | 2026-05-13 | Warnings | M013 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Chain Drug Marketing Association, Inc. | 17216bf3-bed0-4d7a-994e-76a0e4c79c5c | 2026-05-13 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | A-S Medication Solutions | c445c6bb-69a8-492e-b100-ce942707f203 | 2026-05-12 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Valu Merchandisers Company | 1754a9f2-e7e5-4efb-a728-6ba2a7155d11 | 2026-05-12 | Warnings | M013 |
| Menstrual Relief | ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE | Target Corporation | bc65e205-64fd-4764-8c5e-2793af4e9adf | 2026-05-12 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | DOLGENCORP, LLC | a7e27000-a26b-46c2-823e-663f4e76db74 | 2026-05-11 | Warnings | M013 |
| Market Basket Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Demoulas Super Markets, Inc. | e15439c7-0e3c-7752-e053-2995a90a1a40 | 2026-05-11 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | fdb7331a-d029-8b2a-e053-6294a90adfcd | 4 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | fdb7331a-d029-8b2a-e053-6294a90adfcd | 4 |
| 198440 | APAP 500 MG Oral Tablet | SY | fdb7331a-d029-8b2a-e053-6294a90adfcd | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-3437-1 | 68071343701 | 120 TABLET in 1 BOTTLE (68071-3437-1) | 120 tablet | 2026-01-13 | No | No | Current |
| 68071-3437-2 | 68071343702 | 20 TABLET in 1 BOTTLE (68071-3437-2) | 20 tablet | 2023-06-09 | No | No | Current |
| 68071-3437-3 | 68071343703 | 30 TABLET in 1 BOTTLE (68071-3437-3) | 30 tablet | 2026-07-24 | No | No | Current |
| 68071-3437-5 | 68071343705 | 45 TABLET in 1 BOTTLE (68071-3437-5) | 45 tablet | 2023-06-09 | No | No | Current |