TYLENOL Extra Strength
- Product NDC
- 53209-1001
- 11-digit product format
- 532091001
- Labeler code
- 53209
- Product ID
- 53209-1001_37e8d749-91bb-a5bc-e063-6394a90ac8a8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Morning Star OTC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1984-08-19
- 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
- TYLENOL Extra Strength
- 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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8502ea21-937d-4b33-a3e0-ffab5dc38cd8 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53209-1001-1 | TYLENOL Extra Strength | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 1 | |
| 53209-1001-2 | TYLENOL Extra Strength | 25 in 1 POUCH | TABLET, FILM COATED | 25 | 1 |
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 | 8502ea21-937d-4b33-a3e0-ffab5dc38cd8 | 1 |
| 209459 | Tylenol Extra Strength 500 MG Oral Tablet | PSN | 8502ea21-937d-4b33-a3e0-ffab5dc38cd8 | 1 |
| 209459 | acetaminophen 500 MG Oral Tablet [Tylenol] | SBD | 8502ea21-937d-4b33-a3e0-ffab5dc38cd8 | 1 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 8502ea21-937d-4b33-a3e0-ffab5dc38cd8 | 1 |
| 198440 | APAP 500 MG Oral Tablet | SY | 8502ea21-937d-4b33-a3e0-ffab5dc38cd8 | 1 |
| 209459 | APAP 500 MG Oral Tablet [Tylenol] | SY | 8502ea21-937d-4b33-a3e0-ffab5dc38cd8 | 1 |
| 209459 | Tylenol 500 MG Oral Tablet | SY | 8502ea21-937d-4b33-a3e0-ffab5dc38cd8 | 1 |
| 209459 | Tylenol Extra Strength 500 MG Oral Tablet | SY | 8502ea21-937d-4b33-a3e0-ffab5dc38cd8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53209-1001-1 | 53209100101 | 2 in 1 BLISTER PACK | Historical | ||||
| 53209-1001-2 | 53209100102 | 25 BLISTER PACK in 1 POUCH (53209-1001-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1001-1) | 25 blister pack | 2025-06-19 | No | No | Current |