ACETAMINOPHEN
- Product NDC
- 70010-161
- 11-digit product format
- 700100161
- Labeler code
- 70010
- Product ID
- 70010-161_5d4ed747-ce30-9f26-e063-6394a90a5956
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Granules Pharmaceuticals Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-02-15
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 70010-161-10 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 70010-161-05 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 70010-161-01 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 70010-161-10 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 70010-161-05 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 70010-161-01 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 70010-161-10 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 70010-161-05 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 70010-161-01 | f268b84574a6… | 26285f5ac5df… |
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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70010-161-01 | ACETAMINOPHEN | 1 in 1 CARTON | TABLET | 1 | 5 | |
| 70010-161-01 | ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET | 100 | 5 | |
| 70010-161-05 | ACETAMINOPHEN | 500 in 1 BOTTLE | TABLET | 500 | 5 | |
| 70010-161-10 | ACETAMINOPHEN | 1000 in 1 BOTTLE | TABLET | 1000 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70010-161-01 | EA - Each | 70010-161 | 0ed1eb5c-3333-4e86-b023-551784d2efd3 | 1 | 2023-08-08 |
| 70010-161-05 | EA - Each | 70010-161 | 2e1e4e0f-4cc6-437a-aa64-bf9985bbf911 | 1 | 2023-08-08 |
| 70010-161-10 | EA - Each | 70010-161 | 70fddc44-fb63-4964-a389-6514804206a8 | 1 | 2024-02-14 |
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 |
|---|---|---|---|---|---|---|
| Sanatos Multi Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI | Pharmadel LLC | 0ab11691-5b29-55fc-e063-6394a90aa328 | 2023-11-17 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 1e223faa-f6d0-4235-bc4c-6cfca84a5b0a | 2023-11-17 | Warnings | M013 |
| SanaTos X | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | 85b8ef3d-7318-7f3b-e053-2991aa0a0777 | 2023-11-14 | Warnings | M013 |
| RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 8badbaad-eb35-4251-a779-00474819360d | 2023-11-13 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Trifecta Pharmaceuticals USA LLC | 09935a74-34b0-0e7c-e063-6294a90a7c83 | 2023-11-07 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | AMERIFOODS TRADING COMPANY | f6dd6396-93e9-1096-e053-6394a90af06d | 2023-11-02 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | RETAIL BUSINESS SERVICES , LLC. | eb644e9e-36dc-5f84-e053-2a95a90affa5 | 2023-11-02 | Warnings | M013 |
| Good Sense Childrens Pain and Fever | ACETAMINOPHEN | Proficient Rx LP | 46527b1f-7515-44ce-b5cb-9d24223b9af1 | 2023-11-01 | Warnings | M013 |
| Aspirin | ASPIRIN | A-S Medication Solutions | 12feb32b-4b8c-4b17-9e86-cb286457b088 | 2023-11-01 | Warnings | M013 |
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Proficient Rx LP | af8b30a0-7a56-4557-8404-cc8059fcd6bc | 2023-11-01 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | AMERIFOODS TRADING COMPANY | f6dd387d-c768-9443-e053-6394a90aca14 | 2023-10-31 | Warnings | M013 |
| ASPIRIN | ASPIRIN | AMERIFOODS TRADING COMPANY | f6cec280-17a5-5c5d-e053-6394a90a81aa | 2023-10-31 | Warnings | M013 |
| Regular Strength Aspirin | ASPIRIN | CARDINAL HEALTH, INC. | 8aaa82c6-b46b-25c5-e053-2a95a90a3793 | 2023-10-30 | Warnings | M013 |
| SafeTynadol | ACETAMINOPHEN | Sinew Pharma Inc. | b956d527-7ea7-e084-e053-2a95a90a866d | 2023-10-28 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Magno-Humphries, Inc. | 9d2275c8-0c3d-d2b3-e053-2995a90a368e | 2023-10-27 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Magno-Humphries, Inc. | 9d22bedb-9fb3-8421-e053-2a95a90acf4a | 2023-10-27 | Warnings | M013 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | Magno-Humphries, Inc. | 9d22d642-8aaf-d17e-e053-2995a90ae182 | 2023-10-27 | Warnings | M013 |
| ENTERIC COATED ASPIRIN | ASPIRIN | Magno-Humphries, Inc. | a7c02378-4213-4e57-aca2-2437ad02f786 | 2023-10-27 | Warnings | M013 |
| Extraprin | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Magno-Humphries, Inc. | 9d22cdc8-29c5-4273-e053-2a95a90ad0bf | 2023-10-27 | Warnings | M013 |
| Regular Strength Enteric coated aspirin | ASPIRIN | Geri-Care Pharmaceutical Corp | c321208c-f192-42c5-9454-e0df5d02d685 | 2023-10-26 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | d5d49146-665e-4a93-e053-2995a90aca59 | 5 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | d5d49146-665e-4a93-e053-2995a90aca59 | 5 |
| 198440 | APAP 500 MG Oral Tablet | SY | d5d49146-665e-4a93-e053-2995a90aca59 | 5 |
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 4965fc33-f815-d49e-e063-6394a90a119c | 1 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 4965fc33-f815-d49e-e063-6394a90a119c | 1 |
| 198440 | APAP 500 MG Oral Tablet | SY | 4965fc33-f815-d49e-e063-6394a90a119c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70010-161-01 | 70010016101 | 1 BOTTLE in 1 CARTON (70010-161-01) / 100 TABLET in 1 BOTTLE | 1 bottle | 2022-02-15 | 0000-00-00 | No | No | Current |
| 70010-161-05 | 70010016105 | 500 TABLET in 1 BOTTLE (70010-161-05) | 500 tablet | 2022-02-15 | 0000-00-00 | No | No | Current |
| 70010-161-10 | 70010016110 | 1000 TABLET in 1 BOTTLE (70010-161-10) | 1000 tablet | 2022-02-15 | No | No | Current |