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 |
|---|---|---|---|---|---|---|
| good sense pain relief | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 3c1f505d-0319-a179-e063-6294a90a0b17 | 2025-08-11 | Warnings | M013 |
| Aspirin | ASPIRIN | PROSTAT FIRST AID | 3bdb9d89-9000-69f9-e063-6294a90a0c97 | 2025-08-08 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Prostat First Aid | 3bdbea6a-3f11-9142-e063-6294a90a20ea | 2025-08-08 | Warnings | M013 |
| Aspi-Cor | ASPIRIN | L.N.K. International, Inc. | 9f919a48-ffd8-49fa-b6fd-ec71cc12e64b | 2025-08-08 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | A-S Medication Solutions | 8575ef9d-2eae-412a-a252-82b03f4d5275 | 2025-08-08 | Warnings | M013 |
| Aspirin | ASPIRIN | A-S Medication Solutions | 7a91b1df-8d6d-4205-9822-bc4d800555f7 | 2025-08-08 | Warnings | M013 |
| M-PAP | ACETAMINOPHEN | Bryant Ranch Prepack | 3d6bf733-800c-420a-a9ab-ae4a26134799 | 2025-08-08 | Warnings | M013 |
| Aspirin | ASPIRIN | A-S Medication Solutions | 44b8c203-37c5-425e-9110-f7eb614f9c2d | 2025-08-08 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION INC | c46688ec-e976-4f76-9265-645f59970ff5 | 2025-08-06 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | P & L Development, LLC | c54ad829-f2e8-4367-b439-af20b0ef8ad2 | 2025-08-06 | Warnings | M013 |
| TYLENOL Regular Strength | ACETAMINOPHEN | Kenvue Brands LLC | 398d8996-b522-a3cd-e063-6394a90ac2c8 | 2025-08-06 | Warnings | M013 |
| Aspirin | ASPIRIN | Marlex Pharmaceuticals Inc. | cc7013ea-cf30-6f59-e053-2a95a90a1148 | 2025-08-05 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Prostat First Aid | 3ba313db-bafe-1947-e063-6294a90a528c | 2025-08-05 | Warnings | M013 |
| MEDIQUE APAP acetaminophen | MEDIQUE APAP ACETAMINOPHEN | HF Acquisition Co LLC, DBA HealthFirst | 3ba5c802-fe5a-e42a-e063-6394a90ae67e | 2025-08-05 | Warnings | M013 |
| meijer EXTRA STRENGTH Pain Relief PM CAPLET | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Meijer, Inc. | 376fed3b-7625-6379-e063-6394a90a188d | 2025-08-05 | Warnings | M013 |
| CAREONE INFANTS ACETAMINOPHEN | ACETAMINOPHEN | Retail Business Services, LLC | b8024ec2-97c6-4aa1-b1dd-894164f48811 | 2025-08-04 | Warnings | M013 |
| Exaprin Plus | ASPIRIN, ACETAMINOPHEN, CAFFEINE | HART Health | 8a9ca680-e6cf-4ee4-8a5f-bd6d7470b848 | 2025-08-04 | Warnings | M013 |
| Aspirin | ASPIRIN | Proficient Rx LP | 2ef0757a-fe5f-47de-906a-a4d47a0d0534 | 2025-08-01 | Warnings | M013 |
| Good Sense Pain Relief | ACETAMINOPHEN | Proficient Rx LP | b4cb4a62-9ef7-4185-8770-e9a806c2fb3f | 2025-08-01 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | AAA Pharmaceutical, Inc. | 36ad21a3-6229-e91b-e063-6394a90a7933 | 2025-07-29 | 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 |