TYLENOL Extra Strength
- Product NDC
- 85237-1946
- 11-digit product format
- 852371946
- Labeler code
- 85237
- Product ID
- 85237-1946_5543ed1a-4081-afdd-e063-6394a90aa77b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Select Consumer Group LLC
- 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
- 2027-12-31
- 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
- 2027-12-31
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 |
|---|---|
| 529d3a51-a248-7c02-e063-6294a90a10ae | Available on FDA.report |
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 325 MG EC | ASPIRIN | Reliable 1 Laboratories LLC | 2ab8564f-f958-7512-e054-00144ff88e88 | 2025-01-15 | Warnings | M013 |
| ACETAMINOPHEN 325 MG | ACETAMINOPHEN | Reliable 1 Laboratories LLC | 25626b46-78f8-7226-e054-00144ff8d46c | 2025-01-15 | Warnings | M013 |
| Aspirin 81 mg | ASPIRIN | Reliable 1 Laboratories LLC | b247fe39-7f65-e502-e053-2a95a90a08f1 | 2025-01-15 | Warnings | M013 |
| Pharbetol | ACETAMINOPHEN 500MG | Ulai Health LLC | e64ce7b1-4501-4b51-b012-1882ed153b42 | 2025-01-13 | Warnings | M013 |
| Aspirin Regular Strength | ASPIRIN 325MG | Ulai Health LLC | 26942d32-d6e6-464d-8fc4-ffd9806d3e62 | 2025-01-12 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | WAL-MART STORES INC | a354b24e-0913-829f-e053-2995a90ad407 | 2025-01-11 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | WAL-MART STORES INC | 8f221fdb-8138-c1a8-e053-2995a90a29c2 | 2025-01-11 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | A-S Medication Solutions | 3294ba24-f198-485e-88fc-435964434b80 | 2025-01-09 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Major Pharmaceuticals | 32ea1230-f9ae-46b0-910e-05cd187cee34 | 2025-01-09 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | Pioneer Life Sciences, LLC | e817bc4a-43ef-4126-b903-aabd1390cd0c | 2025-01-08 | Warnings | M013 |
| GeriCare Liquid Pain Relief | ACETAMINOPHEN | Geri-Care Pharmaceuticals, Corp | 85a074da-14b7-4db5-9d47-8ad19f520721 | 2025-01-06 | Warnings | M013 |
| Aspirin 81 mg Low Dose | ASPIRIN | Meijer Distribution Inc | eb29d6be-f095-44b2-b6ed-7e4167b596f8 | 2025-01-02 | Warnings | M013 |
| Headache, Circle K | ACETAMINOPHEN, CAFFEINE, ASPIRIN TABLET | Lil' Drug Store Products, Inc. | e711ff0a-2fa0-1f2a-e053-2a95a90a4e38 | 2024-12-31 | Warnings | M013 |
| Extra Strength Headache, Lil Drug Store | EXTRA STRENGHT HEADACHE RELIEF- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET | Lil' Drug Store Products, Inc. | 0c41deda-490b-f5d2-e063-6394a90a5047 | 2024-12-31 | Warnings | M013 |
| Extra Strength Headache, Circle K | ACETAMINOPHEN/ASPIRIN/CAFFEINE TABLET | Lil' Drug Store Products, Inc. | d18e1631-de43-4b29-e053-2995a90af56d | 2024-12-31 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN 500 MG, FILM-COATED TABLET | Lil' Drug Store Products, Inc. | e5f9def4-4cf5-4e06-e053-2995a90a07ea | 2024-12-31 | Warnings | M013 |
| Regular Strength Pain Relief | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 6158e954-32d8-4718-e053-2a91aa0a27f3 | 2024-12-31 | Warnings | M013 |
| Aspirin | ASPIRIN | Advanced Rx Pharmacy of Tennessee, LLC | f8375029-e567-c6a5-e053-6394a90a5b67 | 2024-12-31 | Warnings | M013 |
| Extra Strength Headache Relief | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Dollar General | 4907056d-6013-46b1-ae86-469dc3001591 | 2024-12-31 | Warnings | M013 |
| Pediacare Childrens Grape | ACETAMINOPHEN | RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH | f9d531a2-234c-4feb-8f05-212dbee83dfe | 2024-12-30 | Warnings | M013 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85237-1946-1 | 85237194601 | 1 POUCH in 1 BLISTER PACK (85237-1946-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) | 1 pouch | 2025-06-04 | No | No | Current |
| 85237-1946-2 | 85237194602 | 2 POUCH in 1 BLISTER PACK (85237-1946-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) | 2 pouch | 2025-06-04 | No | No | Current |
| 85237-1946-3 | 85237194603 | 20 POUCH in 1 CARTON (85237-1946-3) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) | 20 pouch | 2025-06-04 | No | No | Current |
| 85237-1946-4 | 85237194604 | 25 POUCH in 1 CARTON (85237-1946-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) | 25 pouch | 2025-06-04 | No | No | Current |
| 85237-1946-5 | 85237194605 | 30 POUCH in 1 CARTON (85237-1946-5) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) | 30 pouch | 2025-06-04 | No | No | Current |
| 85237-1946-6 | 85237194606 | 50 POUCH in 1 CARTON (85237-1946-6) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) | 50 pouch | 2025-06-04 | No | No | Current |
| 85237-1946-7 | 85237194607 | 3 POUCH in 1 BLISTER PACK (85237-1946-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) | 3 pouch | 2025-06-04 | No | No | Current |