Acetaminophen
- Product NDC
- 0615-8609
- 11-digit product format
- 006158609
- Labeler code
- 0615
- Product ID
- 0615-8609_d0184723-a7f2-46e7-904e-87b206bf639c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-09
- Substance
- ACETAMINOPHEN
- Active strength
- 325 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 | 325 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 313782 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 19735691-33f3-4e19-85ad-e5f270251ec5 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0615-8609-67 | Acetaminophen | 60 in 1 BLISTER PACK | TABLET, FILM COATED | 60 | 1 |
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 | Aurohealth LLC | 30756257-f748-4a5d-b031-dd267d0f91ad | 2023-11-29 | Warnings | M013 |
| Aurophen Regular Strength | ACETAMINOPHEN | Aurohealth LLC | 8eda893f-5266-4b7a-95b9-2e194973cf06 | 2023-11-29 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | Aurohealth LLC | 00ec6518-b5e3-49d1-a342-139381c3bfd2 | 2023-11-29 | Warnings | M013 |
| CHILDRENS PAIN RELIEF | ACETAMINOPHEN | Better Living Brands, LLC | fadb4c09-071f-56c0-e053-6294a90ae6c1 | 2023-11-28 | Warnings | M013 |
| Acetaminophen and Diphenhydramine hydrochloride | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Better Living Brands, LLC | fc07d516-9ffe-9989-e053-6294a90ae1a5 | 2023-11-28 | Warnings | M013 |
| NOTTS - Tension Headache | ACETAMINOPHEN, CAFFEINE | VIVUNT PHARMA LLC | 08f2ae03-967b-ad7e-e063-6294a90a8484 | 2023-11-24 | Warnings | M013 |
| Sanatos Multi Symptoms Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 0a60326a-a17b-e843-e063-6394a90ac211 | 2023-11-22 | Warnings | M013 |
| Sanatos Nighttime Multi Symptoms | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 0ab188f3-f7f9-d665-e063-6294a90a198a | 2023-11-22 | Warnings | M013 |
| ASPIRIN | ASPIRIN | TIME CAP LABS INC | fe12519c-3e5f-4592-bd34-2d6b81b981f4 | 2023-11-22 | Warnings | M013 |
| Rugby Regular Strength Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 400d4a29-9e39-4e74-8272-37be5d789924 | 2023-11-22 | Warnings | M013 |
| RIGHT REMEDIES Pain Relief Extra Strength Caplet | ACETAMINOPHEN | Strive Pharmaceuticals Inc. | dcce28d9-8528-489e-b995-1d98e9d0e6ad | 2023-11-21 | Warnings | M013 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313782 | acetaminophen 325 MG Oral Tablet | PSN | 19735691-33f3-4e19-85ad-e5f270251ec5 | 1 |
| 313782 | acetaminophen 325 MG Oral Tablet | SCD | 19735691-33f3-4e19-85ad-e5f270251ec5 | 1 |
| 313782 | APAP 325 MG Oral Tablet | SY | 19735691-33f3-4e19-85ad-e5f270251ec5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0615-8609-67 | 00615860967 | 60 TABLET, FILM COATED in 1 BLISTER PACK (0615-8609-67) | 2026-02-17 | No | No | Current |