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 |
|---|---|---|---|---|---|---|
| Childrens Pain Relief Dye free | ACTEMINOPHEN | BETTER LIVING BRANDS LLC. | 41f504d1-29c4-f075-e063-6394a90ad64c | 2026-04-11 | Warnings | M013 |
| Dr. Simi Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Farmacias De Similares TX LLC | 4f1e1f1a-44f4-2356-e063-6294a90a8cdd | 2026-04-10 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | Akron Pharma Inc. | e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed | 2026-04-10 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | Akron Pharma Inc. | 28413cb3-22c4-40e2-ad6b-42beb438dea3 | 2026-04-10 | Warnings | M013 |
| Pain Reliever Childrens | ACETAMINOPHEN | H E B | 7e43de11-d20b-4920-a04d-3c1b5d35e005 | 2026-04-09 | Warnings | M013 |
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Navajo Manufacturing Company Inc. | f7e572e9-82a7-2127-e053-6394a90ab01a | 2026-04-08 | Warnings | M013 |
| Bayer Genuine Aspirin | ASPIRIN | Navajo Manufacturing Company Inc. | f6f2ce71-5728-aefb-e053-6394a90a20e4 | 2026-04-08 | Warnings | M013 |
| Midol | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | Navajo Manufacturing Company Inc. | cabd10f2-a91e-4406-9249-915e306c867b | 2026-04-08 | Warnings | M013 |
| Aspirin | ASPIRIN | HyVee Inc | 3730ee46-b241-44eb-94fa-52b9d12a9c35 | 2026-04-08 | Warnings | M013 |
| Aspirin | ASPIRIN | Walgreen Company | 82cc404b-fcf5-4e48-ab1a-09d8c47f9e04 | 2026-04-08 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | 9efcce86-dd57-4ea2-ad31-d2038eb61bf1 | 2026-04-07 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 1b164780-ec84-4187-8afa-6f8a0da550fc | 2026-04-07 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 201b860d-dc3c-4380-affa-e757bf2103cf | 2026-04-07 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Walgreens | 6e7475e2-81a9-43b5-9b81-b58ab761a6f4 | 2026-04-07 | Warnings | M013 |
| Pain Relief Aspirin Low Dose | ASPIRIN | Rite Aid Corporation | 503408ed-e799-48a0-8d38-3034f4a0ead5 | 2026-04-02 | Warnings | M013 |
| Aspirin 81 mg | ASPIRIN | Lidl US LLC | 468f4a2f-60f7-4808-95d7-a00be1bb112f | 2026-04-02 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | Grocery Outlet, Inc. | 44de6f5a-0b5c-6c28-e063-6394a90a7e0b | 2026-04-02 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | ARMY AND AIR FORCE EXCHANGE SERVICE | 26ae0d0a-34c0-4d16-951a-8d5a463c808b | 2026-04-02 | Warnings | M013 |
| Pain Reliever plus Sleep Aid NightTime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Kroger Company | 286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d0 | 2026-04-02 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | COSTCO WHOLESALE CORPORATION | c8a8986b-1ab4-9da0-71da-42595db08b44 | 2026-04-02 | 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 |