acetaminophen
- Product NDC
- 68071-3437
- 11-digit product format
- 680713437
- Labeler code
- 68071
- Product ID
- 68071-3437_575e7de2-8194-8e73-e063-6394a90a1d8b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-07-26
- 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
- acetaminophen
- 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#
| Identifier | FDA.report destination |
|---|---|
| 198440 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fdb7331a-d029-8b2a-e053-6294a90adfcd | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3437-1 | acetaminophen | 120 in 1 BOTTLE | TABLET | 120 | 4 | |
| 68071-3437-2 | acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | 4 | |
| 68071-3437-5 | acetaminophen | 45 in 1 BOTTLE | TABLET | 45 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3437 | ACETAMINOPHEN TABLET [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 3 package rows | 20240815_fdb7331a-d029-8b2a-e053-6294a90adfcd.zip |
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 |
|---|---|---|---|---|---|---|
| Pain Reliever | ACETAMINOPHEN | HHH Pharmaceuticals | 0c66b05d-132d-4c79-abfe-415fd68bbb9c | 2026-05-06 | Warnings | M013 |
| Aspirin | ASPIRIN | Better Living Brands, LLC | 5ebd04d8-52c7-4c72-a4c1-fc7fd488ea24 | 2026-05-06 | Warnings | M013 |
| Back and Body Extra Strength | ASPIRIN, CAFFEINE | Cardinal Health 110, LLC. DBA Leader | 519eb216-9fa6-4d60-a2a4-3310bdb5b4ab | 2026-05-06 | Warnings | M013 |
| Aspirin | ASPIRIN | Geiss, Destin & Dunn Inc. | b8f6e486-5332-4c46-ab6c-7de04c91c60b | 2026-05-06 | Warnings | M013 |
| MAX relief junior Grape | CHILDRENS ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | c60494f0-5a50-41da-bcb4-88178ded54b7 | 2026-05-05 | Warnings | M013 |
| equate pain relief pm | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | WALMART INC. | 85129749-c1a7-4c4a-933f-c3c4768e2cdd | 2026-05-05 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | ARMY AND AIR FORCE EXCHANGE SERVICE | f3feca65-adc1-469f-bef6-12c860599abe | 2026-05-04 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Strategic Sourcing Services LLC | 4dda3534-4e83-447b-be75-33dadce06c47 | 2026-05-04 | Warnings | M013 |
| Aspirin Low Dose Chewable Orange | ASPIRIN | Major Pharmaceuticals | 4ba6eed3-004a-4576-b7f7-685fae49cf6a | 2026-05-04 | Warnings | M013 |
| Back and Body | ASPIRIN, CAFFEINE | Kroger Company | 366b58db-1ac3-427b-b42a-5f56a14e298c | 2026-05-01 | Warnings | M013 |
| Tylenol PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Savings Distributors LLC | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 2026-05-01 | Warnings | M013 |
| Tylenol Extra Strength | ACETAMINOPHEN | Savings Distributors LLC | 8ed90757-833e-f4d9-e053-2995a90a29db | 2026-05-01 | Warnings | M013 |
| Acetaminophen , Aspirin and Caffeine | ACETAMINOPHEN , ASPIRIN AND CAFFEINE | Softgel Healthcare Pvt Ltd | 4543e156-1deb-666e-e063-6394a90a719c | 2026-04-27 | Warnings | M013 |
| Acetaminophen , Caffeine and pyrilamine maleate | ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE | Softgel Healthcare Pvt Ltd | 45478958-ad86-4d87-e063-6394a90a3c45 | 2026-04-27 | Warnings | M013 |
| Medique at Home Aspirin | ASPIRIN | Sportpharm LLC | 0f2aa75e-534f-478b-811e-fb492b7af9bb | 2026-04-24 | Warnings | M013 |
| Medique at Home APAP Extra Strength | ACETAMINOPHEN 500 MG | Sportpharm LLC | cc280926-ad94-4017-a04a-b4315807eacb | 2026-04-24 | Warnings | M013 |
| Aspirin | ASPIRIN | Health Pharma USA LLC | 503868bb-48e0-b718-e063-6394a90a9c5b | 2026-04-24 | Warnings | M013 |
| BC CHERRY | ASPIRIN AND CAFFEINE | Medtech Products Inc. | c5fa6660-a549-49ff-ac2b-5799afa22ec5 | 2026-04-24 | Warnings | M013 |
| Doans Maximum Strength | MAGNESIUM SALICYLATE | Dr. Reddy's Laboratories Inc. | c906df41-bb45-03ea-b1a8-2b9816d55c97 | 2026-04-24 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | 48912649-9fa1-a11f-e063-6294a90a8a72 | 2026-04-23 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | fdb7331a-d029-8b2a-e053-6294a90adfcd | 4 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | fdb7331a-d029-8b2a-e053-6294a90adfcd | 4 |
| 198440 | APAP 500 MG Oral Tablet | SY | fdb7331a-d029-8b2a-e053-6294a90adfcd | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-3437-1 | 68071343701 | 120 TABLET in 1 BOTTLE (68071-3437-1) | 120 tablet | 2026-01-13 | No | No | Current |
| 68071-3437-2 | 68071343702 | 20 TABLET in 1 BOTTLE (68071-3437-2) | 20 tablet | 2023-06-09 | No | No | Current |
| 68071-3437-3 | 68071343703 | 30 TABLET in 1 BOTTLE (68071-3437-3) | 30 tablet | 2026-07-24 | No | No | Current |
| 68071-3437-5 | 68071343705 | 45 TABLET in 1 BOTTLE (68071-3437-5) | 45 tablet | 2023-06-09 | No | No | Current |