Acetaminophen
- Product NDC
- 61504-104
- 11-digit product format
- 615040104
- Labeler code
- 61504
- Product ID
- 61504-104_09083a11-e010-d76d-e063-6294a90a7981
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- AMERIFOODS TRADING COMPANY
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-30
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- 2026-12-31
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 |
|---|---|
| f6dd387d-c768-9443-e053-6394a90aca14 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61504-104-04 | Acetaminophen | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 3 | |
| 61504-104-04 | Acetaminophen | 1 in 1 CARTON | TABLET, COATED | 1 | 3 | |
| 61504-104-06 | Acetaminophen | 500 in 1 BOTTLE, PLASTIC | TABLET, COATED | 500 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Regular Strength Pain Relief | ACETAMINOPHEN | VALU MERCHANDISERS COMPANY | f7e87eac-59fb-4a72-b5c6-02953112be6a | 2025-12-11 | Warnings | M013 |
| Aspirin | ASPIRIN | VALU MERCHANDISERS COMPANY | 049ec1aa-66b3-9273-e063-6294a90a221b | 2025-12-11 | Warnings | M013 |
| Aspirin 325 | ASPIRIN | Walgreen Company | f7a5d612-443c-4701-ad3b-8eb53c87bece | 2025-12-11 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | 355a094c-bed9-4959-8cf0-619f0e246105 | 2025-12-11 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | fac4e0c6-684f-45a1-99f2-de4de4017cc8 | 2025-12-11 | Warnings | M013 |
| Pain Reliever PM extra strength | ACETAMINOPHEN DIPHENHYDRAMINE HCL | P & L Development, LLC | 90eba2e8-52c3-43f5-ba93-4a520368c7f4 | 2025-12-11 | Warnings | M013 |
| Midol Complete, Travel BASIX | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | Lil' Drug Store Products, Inc | d6d47af8-5f8c-4c8c-a8c6-aa214ec23bca | 2025-12-10 | Warnings | M013 |
| Tylenol PM Extra Strength, CVP HEALTH | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 643371f2-e330-441e-8932-b3aec4b179d2 | 2025-12-10 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | United Natural Foods, Inc. dba UNFI | 18b79449-5c4c-41ce-9609-80f5efa0375c | 2025-12-09 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | AAA Pharmaceutical, Inc. | 36ad34f4-4e66-f371-e063-6394a90ae76a | 2025-12-09 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | LIDL US LLC | ec543339-20ab-2cba-e053-2995a90ac740 | 2025-12-09 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | c57c10fc-f182-4153-8974-ef359a5f5ac1 | 2025-12-09 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | HEB | f7958347-4e9c-4698-8749-7ca7023ee2ba | 2025-12-09 | Warnings | M013 |
| Pain Relief Rapid Release Gelcaps Extra Strength | ACETAMINOPHEN | Safeway | c830d1ac-c4c5-4eb1-98bb-22707cb6db91 | 2025-12-09 | Warnings | M013 |
| Menstrual Pain Relief Complete | ACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINE | Shield Pharmaceuticals Corp | 5efd6c61-74ed-4253-896a-e4a40bd8f25b | 2025-12-09 | Warnings | M013 |
| Excedrin Extra Strength, TRAVEL BASIX | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Lil Drug Store Products, Inc | 7f0f8b3c-c226-4a3a-af46-a708f345e4f5 | 2025-12-09 | Warnings | M013 |
| childrens acetaminophen | ACETAMINOPHEN | United Natural Foods, Inc. dba UNFI | f65203a2-64f0-4138-97e4-6eab99194178 | 2025-12-09 | Warnings | M013 |
| Pain Reliever PM, Extra Strength, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 45735cd8-ac07-3f12-e063-6294a90a0cb2 | 2025-12-08 | Warnings | M013 |
| BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN | ACETAMINOPHEN | BJWC | e27b6637-ef32-44b5-a531-b6617d02fbbf | 2025-12-08 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALGREENS | 3f9f1740-9e8b-6a2d-e063-6294a90a67cb | 2025-12-06 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | f6dd387d-c768-9443-e053-6394a90aca14 | 3 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | f6dd387d-c768-9443-e053-6394a90aca14 | 3 |
| 198440 | APAP 500 MG Oral Tablet | SY | f6dd387d-c768-9443-e053-6394a90aca14 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 61504-104-04 | 61504010404 | 1 BOTTLE, PLASTIC in 1 CARTON (61504-104-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2023-10-30 | No | No | Current |
| 61504-104-06 | 61504010406 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (61504-104-06) | 2023-10-30 | No | No | Current |