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 Acetaminophen | ACETAMINOPHEN | Bryant Ranch Prepack | 190bb2dc-92b4-4b59-a47f-a0251df8261c | 2025-07-29 | Warnings | M013 |
| Extra Strength NiteTime Pain Relief | ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLET | WALGREENS | c25c75c7-157f-1c0d-e053-2995a90a2e3c | 2025-07-25 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Walmart Inc. | 21ab3d58-bb0e-3e51-e063-6294a90ad415 | 2025-07-25 | Warnings | M013 |
| Childrens TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | 3a935584-6045-0a58-e063-6394a90a40c4 | 2025-07-23 | Warnings | M013 |
| DR. SANA PAIN AND FEVER FOR Children | ACETAMINOPHEN | GADAL Laboratories, Inc | 8a22a5ba-8623-4cca-8723-52b495403461 | 2025-07-23 | Warnings | M013 |
| Duralgina | ACETAMINOPHEN | Menper Distributors Inc. | bb31f66c-80a9-4bdb-983b-cef5d21de5ff | 2025-07-22 | Warnings | M013 |
| Gesteira | ACETAMINOPHEN | Menper Distributors, Inc. | 5a907289-564c-491b-98d5-d7f43eaaa1b2 | 2025-07-22 | Warnings | M013 |
| Extra strength Acetaminophen PM | ACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MG | TIME CAP LABS INC | 010c5c98-fc67-a9c3-e063-6394a90aa640 | 2025-07-21 | Warnings | M013 |
| childrens pain and fever | ACETAMINOPHEN | Meijer Distribution Inc | 44d50d79-6e47-429f-8cbe-6fcac4667732 | 2025-07-18 | Warnings | M013 |
| ADWE Childrens Pain Fever | ACETAMINOPHEN | RARITAN PHARMACEUTICALS INC | 79a3232f-0211-4c8a-acee-4f87e06ffc26 | 2025-07-17 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Walmart Inc. | 24d191ca-a0c4-e1a8-e063-6394a90a7a2a | 2025-07-16 | Warnings | M013 |
| EXTRA STRENGTH HEADACHE RELIEF | ACETAMINOPHEN ASPIRIN CAFFEINE | WAL-MART STORES INC | d97073cd-b5d7-8c09-e053-2a95a90a8938 | 2025-07-16 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | BETTER LIVING BRANDS LLC. | f3005d0c-424e-0ab3-e053-2995a90a1c10 | 2025-07-16 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | Demoulas Super Markets, Inc | 397fa6e1-37b2-8f51-e063-6394a90a7b94 | 2025-07-16 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | Demoulas Super Markets, Inc | 39800c27-f39f-cd60-e063-6394a90acd55 | 2025-07-16 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | Demoulas Super Markets, Inc | 397f2b63-733e-5b44-e063-6394a90a9718 | 2025-07-16 | Warnings | M013 |
| EXTRA STRENGTH PAIN RELIEF | ACETAMINOPHEN, ASPIRIN, CAFFEINE | BETTER LIVING BRANDS, LLC | eb6026d5-d88a-f6b3-e053-2a95a90a5b20 | 2025-07-15 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Safeway | f9597abc-3f01-4b94-8078-228e0b74677e | 2025-07-15 | Warnings | M013 |
| Berkley and Jensen Pain Relief | ACETAMINOPHEN | BJWC | d3ee3341-93b8-487c-921e-2892d213efbb | 2025-07-15 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | CVS Pharmacy | 9e459853-5951-4ae7-88a6-85b502e9dd41 | 2025-07-14 | 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 |