ACETAMINOPHEN
- Product NDC
- 82568-0002
- 11-digit product format
- 825680002
- Labeler code
- 82568
- Product ID
- 82568-0002_34157f6a-3032-4388-e063-6394a90a670f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AARNA USA INC.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-05-15
- 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 |
|---|---|
| 34157f6a-3031-4388-e063-6394a90a670f | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82568-0002-1 | ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 82568-0002-2 | ACETAMINOPHEN | 1000 in 1 BOTTLE | TABLET | 1000 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 82568-0002-1 | EA - Each | 82568-0002 | e252ee47-500b-4edb-82d4-b126ef91b5e9 | 1 | 2025-07-08 |
| 82568-0002-2 | EA - Each | 82568-0002 | fa6dc4e5-951a-4878-968a-9f8ccee927c2 | 1 | 2025-07-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 82568-0002 | ACETAMINOPHEN TABLET [AARNA USA INC.] | 1 | Current NDC, 2 package rows | 20250515_34157f6a-3031-4388-e063-6394a90a670f.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 Regular Strength | ACETAMINOPHEN | United Natural Foods, Inc. dba UNFI | 1462b308-a6a5-49ca-ab29-cacbf62caf0b | 2024-10-17 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | United Natural Foods, Inc. dba UNFI | f3db8598-fe0e-4c53-a023-5f5f8f002cc6 | 2024-10-17 | Warnings | M013 |
| acetaminophen pm extra strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | f86a11af-6d3c-4638-870d-a663ddf49371 | 2024-10-17 | Warnings | M013 |
| Acetaminophen Gelcaps Extra Strength | ACETAMINOPHEN | United Natural Foods, Inc. dba UNFI | 3588a3ef-a493-43ed-96e0-c259f0d087db | 2024-10-17 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | STRATEGIC SOURCING SERVICES LLC | a2186895-944b-48cb-b3c2-eac208866c34 | 2024-10-17 | Warnings | M013 |
| Pain Relief Regular Strength | ACETAMINOPHEN | STRATEGIC SOURCING SERVICES LLC | 6a5d43c8-f4b7-4447-b2e1-53eb12208ef0 | 2024-10-17 | Warnings | M013 |
| Enteric Coated Aspirin | ASPIRIN | STRATEGIC SOURCING SERVICES LLC | 32cc6e05-84c1-4710-bebc-cb6e7133dc54 | 2024-10-17 | Warnings | M013 |
| Aspirin | ASPIRIN | STRATEGIC SOURCING SERVICES LLC | 2ca87a29-1f54-4da4-a66f-3b3dd4f0396c | 2024-10-17 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | STRATEGIC SOURCING SERVICES LLC | 9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e | 2024-10-17 | Warnings | M013 |
| Aspirin | ASPIRIN | Kroger Company | 453f62d5-f580-4d19-bfae-4f78c2a6b6d6 | 2024-10-16 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | FSA Store Inc. | ec6add55-f4a3-7818-e053-2a95a90aee04 | 2024-10-16 | Warnings | M013 |
| ASPIRIN | ASPIRIN | FSA Store Inc. | 062e7b7b-d052-82b0-e063-6294a90a7cce | 2024-10-16 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | FSA STORE INC. | f4322f34-ac19-371e-e053-2a95a90ac864 | 2024-10-16 | Warnings | M013 |
| Low dose Chewable Aspirin | ASPIRIN | FSA STORE INC. | f939b44c-93b6-ca61-e053-6394a90ae586 | 2024-10-16 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 850b5ad8-8774-413c-ae38-022215a94f95 | 2024-10-16 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | DISCOUNT DRUG MART | af0f50d2-3e2d-f723-e053-2995a90a0d4b | 2024-10-16 | Warnings | M013 |
| Enteric Coated Aspirin | ASPIRIN | DISCOUNT DRUG MART | 03ed19dd-1cfc-47d5-b83e-ffa2ebe93f48 | 2024-10-16 | Warnings | M013 |
| PAIN RELIEF Regular Strength | ACETAMINOPHEN | AMERICAN SALES COMPANY | 2e3eabc8-193b-4397-a43c-db838eb16e67 | 2024-10-15 | Warnings | M013 |
| Chewable Aspirin | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | c94d68ea-7f25-881f-e053-2995a90aa47f | 2024-10-15 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | c94d750e-5a85-77f5-e053-2995a90a6915 | 2024-10-15 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 34157f6a-3031-4388-e063-6394a90a670f | 1 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 34157f6a-3031-4388-e063-6394a90a670f | 1 |
| 198440 | APAP 500 MG Oral Tablet | SY | 34157f6a-3031-4388-e063-6394a90a670f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82568-0002-1 | 82568000201 | 100 TABLET in 1 BOTTLE (82568-0002-1) | 100 tablet | 2025-05-15 | No | No | Current |
| 82568-0002-2 | 82568000202 | 1000 TABLET in 1 BOTTLE (82568-0002-2) | 1000 tablet | 2025-05-15 | No | No | Current |