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 |
|---|---|---|---|---|---|---|
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 691b754c-bafc-47e2-a322-cf56245c01f6 | 2024-03-14 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS PHARMACY, INC | fdc80b2a-d7c1-4b3d-9a9b-28182c6320de | 2024-03-14 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | QUALITY CHOICE (Chain Drug Marketing Association) | 2cde052d-22a4-470f-8d6a-7c17061b8ac8 | 2024-03-14 | Warnings | M013 |
| Excedrin Tension Headache | ACETAMINOPHEN, CAFFEINE | Haleon US Holdings LLC | 12c074d1-81ac-47d2-8747-b018cda0058a | 2024-03-13 | Warnings | M013 |
| Menstrual Complete | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | Strive Pharmaceuticals Inc. | 78c12459-3b27-4ed0-943d-520794eb438d | 2024-03-07 | Warnings | M013 |
| Pain Reliever fever Reducer Extra Strength | ACETAMINOPHEN | CVS Pharmacy | 7b5263ad-01b7-4fc5-9384-4da8efe89e35 | 2024-03-06 | Warnings | M013 |
| Excedrin Extra Strength Geltabs | ACETAMINOPHEN, ASPRIN, CAFFEINE | Haleon US Holdings LLC | 11a8439b-0159-4351-b0f5-fe7fad6a33c0 | 2024-03-05 | Warnings | M013 |
| Winco Foods Effervescent Pain Relief | ASPIRIN | Winco Foods, LLC | 128afdd7-a9d1-8957-e063-6294a90af569 | 2024-03-05 | Warnings | M013 |
| Aspirin Low Dose Safety Coated | ASPIRIN | Care One (Retail Business Services, LLC.) | 6659e103-fa03-4de0-af42-d2fbd548a87c | 2024-03-05 | Warnings | M013 |
| Dolex Children Pain and Fever | ACETAMINOPHEN | Pharmadel LLC | f9158463-aeb1-5de0-e053-6294a90a748b | 2024-03-04 | Warnings | M013 |
| SEDALMEX FORTE | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Belmora LLC | 33b3508e-4caa-4d05-9b15-cb82a2ee2d4d | 2024-02-28 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | AMERISOURCE BERGEN | 2b923a97-836c-4dac-a8c0-3047a35fb62e | 2024-02-23 | Warnings | M013 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | BJWC (Berkley & Jensen / BJ's) | b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86 | 2024-02-22 | Warnings | M013 |
| M-PAP | ACETAMINOPHEN | Bryant Ranch Prepack | 31a41976-7f65-42d7-acf5-de9c2c5ca58e | 2024-02-20 | Warnings | M013 |
| Publix Fast Relief Effervescent - Original Flavor | ASPIRIN | PUBLIX SUPER MARKETS INC. | 0a342f72-45fd-3e12-e063-6394a90ae33e | 2024-02-16 | Warnings | M013 |
| Equaline Effervescent Pain Reliever | ASPIRIN | UNITED NATURAL FOODS, INC. DBA UNFI | 0761299a-e913-7665-e063-6394a90a6003 | 2024-02-16 | Warnings | M013 |
| TopCare Effervescent Pain Relief | ASPIRIN | TOPCO ASSOCIATES LLC | 075f36e1-110c-e839-e063-6294a90a89d7 | 2024-02-16 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN | INGLES MARKETS, INC. | 115d0b4f-6f0f-79a9-e063-6394a90ab18a | 2024-02-14 | Warnings | M013 |
| PANADOL | ACETAMINOPHEN | Haleon US Holdings LLC | e1799765-c247-42b4-ad6a-8ba7d136abf2 | 2024-02-06 | Warnings | M013 |
| Panadol Cold and Flu NonDrowsy | ACETAMINOPHEN AND PHENYLEPRINE HCL | Haleon US Holdings LLC | f626ab17-01c9-4493-ba9e-0c8c11146384 | 2024-02-06 | 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 |