ACETAMINOPHEN
- Product NDC
- 63868-678
- 11-digit product format
- 638680678
- Labeler code
- 63868
- Product ID
- 63868-678_8c4fdac0-f82f-4975-a01f-e5d1de264e24
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- CHAIN DRUG MARKETING ASSOCIATION INC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-02-01
- Substance
- ACETAMINOPHEN
- Active strength
- 160 mg/5mL
- 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 | 160 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 307668 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cfc7eac3-35be-4002-b8ef-be1dfc8caf69 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-678-60 | ACETAMINOPHEN | 60 mL in 1 BOTTLE | SUSPENSION | 60 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-678-60 | ML - Milliliter | 63868-678 | 39d16620-cc05-44a6-874f-4bf80214825d | 1 | 2022-09-12 |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | Westminster Pharmaceuticals, LLC | ace5ebac-ec11-4c26-b1e3-954b450ee671 | 2021-05-04 | Warnings | M013 |
| Aspirin Enteric Coated | ASPIRIN 81 MG | Allegiant Health | 8cacf02c-9925-40d4-92bc-78788aa0681a | 2020-11-11 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN 500 MG | Allegiant Health | 8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7 | 2020-03-13 | Warnings | M013 |
| Acetaminophen 500mg ES | ACETAMINOPHEN 500MG | Allegiant Health | 91acc132-01b6-467b-9af5-70f4dc93e087 | 2019-01-08 | Warnings | M013 |
| Acetaminophen 325mg RS | ACETAMINOPHEN 325MG | Allegiant Health | 61c6d281-e59b-4277-bbce-f71c12c2a56d | 2019-01-07 | Warnings | M013 |
| Cold Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Allegiant Health | 9a4c0c43-a71a-4e22-a3d5-9eb9622689a2 | 2019-01-02 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG | Allegiant Health | 423a8445-964c-4cdb-889a-f391ca5253e7 | 2018-12-31 | Warnings | M013 |
| Cold Multi-Symptom Night-time | ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI | Allegiant Health | 3f020cf2-6011-4216-9b39-0b3dc5f0749c | 2018-12-26 | Warnings | M013 |
| Aspirin Chewable | ASPIRIN 81 MG | Allegiant Health | 92b8637b-03a9-461f-b2f6-6eddaa214953 | 2018-12-21 | Warnings | M013 |
| Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Allegiant Health | b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f | 2018-12-21 | Warnings | M013 |
| Clear Choice Regular Strength Pain Reliever | ACETAMINOPHEN | Athlete's Needs, Inc. | d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7 | 2018-12-11 | Warnings | M013 |
| ASPIRIN Enteric Coated | ASPIRIN 81 MG | Allegiant Health | 5910a882-eb40-440f-8a30-c21fbce9050e | 2018-11-07 | Warnings | M013 |
| Aspirin | ASPIRIN 325 MG | Allegiant Health | 88b54062-8b3d-4024-a957-62b3255184b9 | 2018-11-07 | Warnings | M013 |
| Aspirin Enteric Coated | ASPIRIN 81 MG | Allegiant Health | 3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5 | 2018-11-07 | Warnings | M013 |
| Tension Headache Relief | TENSION HEADACHE RELIEF | Allegiant Health | b431a1a3-39c4-4d6c-afdc-c8b017ad89da | 2017-11-16 | Warnings | M013 |
| SED-MAX | ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG | Command Brands, LLC | 4920a0e9-6f88-4df0-8657-77c95a3b9617 | 2017-01-19 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | cfc7eac3-35be-4002-b8ef-be1dfc8caf69 | 2 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | cfc7eac3-35be-4002-b8ef-be1dfc8caf69 | 2 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | cfc7eac3-35be-4002-b8ef-be1dfc8caf69 | 2 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | cfc7eac3-35be-4002-b8ef-be1dfc8caf69 | 2 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | cfc7eac3-35be-4002-b8ef-be1dfc8caf69 | 2 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | cfc7eac3-35be-4002-b8ef-be1dfc8caf69 | 2 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | cfc7eac3-35be-4002-b8ef-be1dfc8caf69 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63868-678-60 | 63868067860 | 60 mL in 1 BOTTLE (63868-678-60) | 60 ml | 2021-02-01 | 0000-00-00 | No | No | Current |