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 |
|---|---|---|---|---|---|---|
| Aspirin | ASPIRIN | United Natural Foods, Inc. dba UNFI | 19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff6 | 2026-07-02 | Warnings | M013 |
| pain relief EXTRA STRENGTH | ACETAMINOPHEN | Meijer Distribution, Inc. | ae84eb7e-a70b-4311-b2dc-ad153047a516 | 2026-07-01 | Warnings | M013 |
| Aspirin 325 mg | ASPIRIN | Hi-Tech Nutraceuticals, LLC | b3426a9a-ea99-da30-e053-2995a90a1e4b | 2026-07-01 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Salado Sales, Inc. | ca21d576-be3c-495d-9dbd-ed514bf65da7 | 2026-07-01 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Meijer Distribution Inc | 4e08a7cb-3894-84c3-e063-6394a90a0b42 | 2026-06-30 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Wal-Mart Stores Inc | 9b1201af-c802-4e19-b192-bbbf34367db4 | 2026-06-30 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | P & L Development, LLC | fc841cba-8f4f-407b-97de-0422977515bd | 2026-06-30 | Warnings | M013 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | United Natural Foods, Inc. dba UNFI | b6ff2b34-51ee-41bc-8b7d-7520ade0bf36 | 2026-06-30 | Warnings | M013 |
| Medline | ASPIRIN | Medline Industries, LP | 4b0c569a-ed7a-e104-e063-6394a90a6d54 | 2026-06-29 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALMART INC. | e50b3f60-b827-426c-8e78-8447c89130fe | 2026-06-29 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Chain Drug Marketing Association, Inc. | e58417f4-3575-4433-ac2e-b7bf9fe8ba10 | 2026-06-29 | Warnings | M013 |
| Dr Kids Pain and Fever | ACETAMINOPHEN | CalmCo LLC | 5534a784-a7b1-5599-e063-6294a90a7961 | 2026-06-27 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Select Consumer Group LLC | 529d3a51-a248-7c02-e063-6294a90a10ae | 2026-06-27 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Sportpharm LLC | 830ffcaa-7ff8-4732-bc84-6a8c5e78722d | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Strategic Sourcing Services LLC | ea2ef485-429e-4c63-ba7b-0a6b32892ad2 | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Chain Drug Marketing Association, Inc. | 055d8420-c189-4a9e-acdc-21627935c8eb | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Topco Associates, LLC | 5f32cf74-dbea-496c-ba23-2040ea354f40 | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Salado Sales, Inc. | cf3139a5-e36e-48e3-bb6c-e102b0cec555 | 2026-06-25 | Warnings | M013 |
| Pain Relief Aspirin | ASPIRIN | Rite Aid Corporation | bd69d3d2-5d38-47c6-98a6-124f7a43b8b0 | 2026-06-25 | Warnings | M013 |
| Aspirin Regular Strength | ASPIRIN | Walgreen Company | 0b27c0fd-7ea8-4588-9169-5ad4e8df77ef | 2026-06-25 | 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 |