TYLENOL
- Product NDC
- 50580-495
- 11-digit product format
- 505800495
- Labeler code
- 50580
- Product ID
- 50580-495_25b09044-067e-eb90-e063-6394a90a6d21
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-12-01
- Substance
- ACETAMINOPHEN
- Active strength
- 325 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
- TYLENOL
- Brand name suffix
- Regular Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| de5c6654-56c5-40d3-a286-f04ed47ac7c8 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-495-01 | TYLENOLRegular Strength | 100 in 1 BOTTLE | TABLET | 100 | 7 | |
| 50580-495-01 | TYLENOLRegular Strength | 1 in 1 CARTON | TABLET | 1 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-495-01 | EA - Each | 50580-495 | 9265db0b-2bac-45b9-bd3d-62f1fb1afa16 | 1 | 2024-08-12 |
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 |
|---|---|---|---|---|---|---|
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Walmart Inc. | 1557bd9b-3e7c-4769-e063-6394a90a9d91 | 2025-11-04 | Warnings | M013 |
| Adult Low Dose Aspirin | ASPIRIN | Rising Pharma Holdings, Inc. | c3c4854e-726e-4926-b044-a5094943c306 | 2025-11-04 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 3e50b3f6-1e1a-41b9-e063-6394a90abe36 | 2025-11-03 | Warnings | M013 |
| Good Sense Pain Relief | ACETAMINOPHEN | L. Perrigo Company | 447de441-7d28-4415-81c5-4fc05622dd05 | 2025-11-03 | Warnings | M013 |
| Children Acetaminophen Oral Solution | ACETAMINOPHEN | VERITYRX. LLC | 42a17f54-7851-84fb-e063-6394a90a9ec1 | 2025-11-02 | Warnings | M013 |
| M-PAP | ACETAMINOPHEN | VERITYRX, LLC | 42a1a128-a2dd-bbc9-e063-6294a90a4fe1 | 2025-11-02 | Warnings | M013 |
| Physicians Care Aspirin | ASPIRIN | Acme United Corporation | aa67ea3a-2741-7ee0-e053-2a95a90a6485 | 2025-10-31 | Warnings | M013 |
| PhysiciansCare Non Aspirin Extra Strength | ACETAMINOPHEN | Acme United Corporation | c7006775-bd5b-412f-963d-ce5a158216c5 | 2025-10-31 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Walgreens | f7aa624b-b00c-4fd3-9965-8e4d2b3eb4ba | 2025-10-31 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | NuCare Pharmaceuticals, Inc. | 41affa1a-5aac-7fc0-e063-6394a90a5557 | 2025-10-30 | Warnings | M013 |
| MAPAP Extra Strength | ACETAMINOPHEN | Major Pharmaceuticals | 34a95450-3f04-4de4-9113-73e7bd5724a0 | 2025-10-29 | Warnings | M013 |
| GOODNOW PAIN RELIEF | ACETAMINOPHEN | Gobrands, Inc | 4d4a78a5-5a88-4f24-b685-c7c6bb5e989e | 2025-10-29 | Warnings | M013 |
| Sanaflu Xtra | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | GRANDALL DISTRIBUTING, LLC | 4af8a566-5251-4d46-8692-87a3a0748334 | 2025-10-28 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Rising Pharma Holdings, Inc. | f8237772-7656-49fb-b1de-f8fcb5fa55ee | 2025-10-28 | Warnings | M013 |
| DG Health Pain Relief | ACETAMINOPHEN | Dolgencorp Inc | 42f0c87c-7020-4af7-9f6b-3a774137e564 | 2025-10-24 | Warnings | M013 |
| GOODYS Hangover | ASPIRIN AND CAFFEINE | Medtech Products Inc. | 0b0067e0-58b0-4581-aa4b-e398c32c559a | 2025-10-23 | Warnings | M013 |
| GOODYS Extra Strength Headache Mixed Fruit Blast | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Medtech Products Inc. | 6cb758bf-5a50-46bb-96e7-65b810b12de0 | 2025-10-23 | Warnings | M013 |
| Nyt Time Sleep Caps | DIPHENHYDRAMINE HYDROCHLORIDE | DISCOUNT DRUG MART | e3f4d063-921d-4503-89a6-26cc9c46b4c9 | 2025-10-23 | Warnings | M013 |
| Anacin | ASPRIN AND CAFFEINE | Insight Pharmaceuticals LLC | 51ab0ee3-3c94-424d-a30a-2d6c14e3d8ff | 2025-10-23 | Warnings | M013 |
| Goodys Back and Body Pain | ACETAMINOPHEN AND ASPRIN | Medtech Products Inc. | 055d0288-61d4-48bc-b91f-6ecc1969beb8 | 2025-10-23 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313782 | acetaminophen 325 MG Oral Tablet | PSN | de5c6654-56c5-40d3-a286-f04ed47ac7c8 | 7 |
| 209387 | Tylenol Regular Strength 325 MG Oral Tablet | PSN | de5c6654-56c5-40d3-a286-f04ed47ac7c8 | 7 |
| 209387 | acetaminophen 325 MG Oral Tablet [Tylenol] | SBD | de5c6654-56c5-40d3-a286-f04ed47ac7c8 | 7 |
| 313782 | acetaminophen 325 MG Oral Tablet | SCD | de5c6654-56c5-40d3-a286-f04ed47ac7c8 | 7 |
| 313782 | APAP 325 MG Oral Tablet | SY | de5c6654-56c5-40d3-a286-f04ed47ac7c8 | 7 |
| 209387 | APAP 325 MG Oral Tablet [Tylenol] | SY | de5c6654-56c5-40d3-a286-f04ed47ac7c8 | 7 |
| 209387 | Tylenol 325 MG Oral Tablet | SY | de5c6654-56c5-40d3-a286-f04ed47ac7c8 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-495-01 | 50580049501 | 1 BOTTLE in 1 CARTON (50580-495-01) / 100 TABLET in 1 BOTTLE | 1 bottle | 2019-12-01 | 0000-00-00 | No | No | Current |