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 |
|---|---|---|---|---|---|---|
| Childrens Pain and Fever | ACETAMINOPHEN | Best Choice (Valu Merchandisers Company) | a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c07 | 2026-03-03 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | HyVee Inc | 6820a515-4004-407b-969b-c4069dc0c3b5 | 2026-02-26 | Warnings | M013 |
| Vicks PainQuil LIQUICAPS PAIN RELIEVER | ACETAMINOPHEN | The Procter & Gamble Manufacturing Company | 4b1b0e2a-0f58-c3b1-e063-6294a90aa1fb | 2026-02-26 | Warnings | M013 |
| Acetaminophen, Diphenhydramine Hydrochloride | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | LEADER/ Cardinal Health 110, Inc. | 7be4d67e-1af9-f059-e053-2991aa0a382e | 2026-02-26 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16 | 2026-02-26 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | 1f4ac0e6-e986-4c22-8248-0691d64e1a30 | 2026-02-26 | Warnings | M013 |
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | Discount Drug Mart | f413a617-1166-4940-b6ec-fae32238a780 | 2026-02-26 | Warnings | M013 |
| aspirin | ASPIRIN | CVS Pharmacy | bd11081f-c5d1-4c98-8f5a-4c45269df79b | 2026-02-26 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | 19735691-33f3-4e19-85ad-e5f270251ec5 | 2026-02-26 | Warnings | M013 |
| Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Kroger | 44520aa1-b63f-4239-e063-6394a90a5e14 | 2026-02-25 | Warnings | M013 |
| Leader Extra Strength Effervescent Antacid and Pain Reliever | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Cardinal Health | c5d7bf5f-3e59-52f2-e053-2a95a90a4a00 | 2026-02-25 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 12fd643d-7c60-453f-a81f-407ed20e8725 | 2026-02-25 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d96a1531-772b-4a5c-89e4-66fff1fa3d78 | 2026-02-25 | Warnings | M013 |
| Gentle Care Kit | ZINC OXIDE | Kenvue Brands LLC | 4b8f7a5a-2fc4-ea00-e063-6294a90ab95b | 2026-02-24 | Warnings | M013 |
| Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE | Haleon US Holdings LLC | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 2026-02-23 | Warnings | M013 |
| Excedrin Extra Strength and Excedrin Tension Headache | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 2026-02-23 | Warnings | M013 |
| Vicks PainQuil and Vicks PainQuil PM LIQUICAPS PAIN RELIEVER | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | The Procter & Gamble Manufacturing Company | 4b829c72-349a-e52c-e063-6394a90aca8d | 2026-02-23 | Warnings | M013 |
| Equate Childrens Pain and Fever | ACETAMINOPHEN | Wal-Mart Stores Inc | 40eedfe9-54e1-40a2-b4a2-55ff708b89cd | 2026-02-23 | Warnings | M013 |
| Excedrin Rapid Relief | ACETAMINOPHEN | Haleon US Holdings LLC | 3a36b7ca-396e-cfd8-e063-6294a90a76ab | 2026-02-22 | Warnings | M013 |
| Vicks PainQuil PM LIQUICAPS PAIN RELIEVER plus NIGHTTIME SLEEP-AID | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | The Procter & Gamble Manufacturing Company | 4b1ad683-9b5a-622f-e063-6294a90a475c | 2026-02-20 | 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 |