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 |
|---|---|---|---|---|---|---|
| Gemma Cut the Cramp | ASPIRIN, CAFFEINE | Rally Labs LLC | 16c9a296-077a-8e12-e063-6294a90a1b8b | 2025-12-29 | Warnings | M013 |
| Blowfish | ASPIRIN, CAFFEINE | Rally Labs LLC | 0d3798bc-04ef-584e-821b-7aa76036b7d1 | 2025-12-29 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE | Pioneer Life Sciences, LLC | ad29a37f-39a2-5c84-e053-2995a90a2f39 | 2025-12-29 | Warnings | M013 |
| Tension Headache Relief | ACETAMINOPHEN, CAFFEINE | Pioneer Life Sciences, LLC | ac9efd62-8fee-b777-e053-2995a90a3783 | 2025-12-29 | Warnings | M013 |
| Childrens Pain Relief and Fever Reducer Oral Suspension Cherry | ACETAMINOPHEN | Puro Pharma Inc. | a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009 | 2025-12-27 | Warnings | M013 |
| Cystex PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Clarion Brands, LLC | 9668a2ca-729e-4172-80b5-33e6c5175ba4 | 2025-12-27 | Warnings | M013 |
| Excedrin Extra Strength Headache | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE | Select Consumer Group | 3caa0a47-de83-90d2-e063-6394a90a3436 | 2025-12-27 | Warnings | M013 |
| Aspirin Pain reliver | ASPIRIN | Pioneer Life Sciences, LLC | c2759844-a49c-450f-e053-2a95a90a2972 | 2025-12-26 | Warnings | M013 |
| Menstrual Complete | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | Pioneer Life Sciences, LLC | aa2de3a5-a20d-33c6-e053-2a95a90ada3e | 2025-12-26 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Discount Drug Mart | 2aa0f9f3-924c-4a4a-bb5f-2a326acc2408 | 2025-12-26 | Warnings | M013 |
| GenCare Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Pioneer Life Sciences, LLC | 667f6f1b-5179-481c-a131-940c7937aada | 2025-12-26 | Warnings | M013 |
| Pharbetol | ACETAMINOPHEN | Pharbest Pharmaceuticals, Inc. | 04dbd98f-c74d-43b2-8bda-74f18be7cf6c | 2025-12-24 | Warnings | M013 |
| Adult Low Dose Aspirin Enteric Coated | ASPIRIN 81MG | Pharbest Pharmaceuticals, Inc. | 45e5bae9-22a7-4699-85ea-5b922af6b96d | 2025-12-24 | Warnings | M013 |
| Aspirin 325 mg | ASPIRIN | BETTER LIVING BRANDS, LLC | 424a242f-c8c6-9dd7-e063-6394a90ab4d5 | 2025-12-24 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | Pharbest Pharmaceuticals, Inc. | 2763a733-d617-4d95-8429-fbf81d9d77fb | 2025-12-24 | Warnings | M013 |
| Pharbetol Regular strength | ACETAMINOPHEN | Pharbest Pharmaceuticals, Inc. | e0a39957-d918-4125-88f9-0e550b976fa1 | 2025-12-24 | Warnings | M013 |
| PHARBETOL | ACETAMINOPHEN 500MG | Pharbest Pharmaceuticals, Inc. | 27337be9-e279-460e-903e-ae4463099599 | 2025-12-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PUBLIX SUPERMARKETS, INC | 08f5af1d-365b-a97c-e063-6394a90a99ae | 2025-12-23 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | Pioneer Life Sciences, LLC | 0d67bb52-7ae3-439e-9e47-4e21eb0ca352 | 2025-12-23 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | Pioneer Life Sciences, LLC | 11e6ec2a-5171-4496-a15f-6ff744bd1f2f | 2025-12-23 | 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 |