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 |
|---|---|---|---|---|---|---|
| Aspirin Low Dose | ASPIRIN | ATLANTIC BIOLOGICALS CORP. | 024c5054-959f-4ea5-a71f-c0e16cc4b90c | 2025-06-24 | Warnings | M013 |
| CHILDRENS ACETAMINOPHEN | CHILDRENS ACETAMINOPHEN ORAL | AARNA USA INC. | 38070d15-2678-4e59-e063-6294a90ab690 | 2025-06-20 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Morning Star OTC | 8502ea21-937d-4b33-a3e0-ffab5dc38cd8 | 2025-06-19 | Warnings | M013 |
| Tylenol PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Morning Star OTC | 6cd07a01-7034-4994-bbd3-bedcdf7d5b83 | 2025-06-19 | Warnings | M013 |
| DRX CHOICE Tension Headache | ACETAMINOPHEN, CAFFEINE | Raritan Pharmaceuticals Inc. | 8a5cb38b-669d-4177-b33b-d73c7ef48d18 | 2025-06-13 | Warnings | M013 |
| good sense childrens pain and fever | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 3777f4fb-d279-199d-e063-6394a90acf36 | 2025-06-13 | Warnings | M013 |
| Aspirina Cafeina | ASPIRIN,CAFFEINE | Bayer HealthCare LLC. | 2e709acc-325a-baca-e063-6394a90a24be | 2025-06-12 | Warnings | M013 |
| Aspirin | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 696f55b1-536c-40c4-91f7-b572c39220db | 2025-06-11 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | CVS Pharmacy, Inc. | 6dea9e11-ff99-63c7-e053-2a91aa0a5b54 | 2025-06-10 | Warnings | M013 |
| Children Acetaminophen Oral Solution | ACETAMINOPHEN | MAJOR PHARMACEUTICALS | cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 | 2025-06-09 | Warnings | M013 |
| Aspirin | ASPIRIN | Trifecta Pharmaceuticals USA LLC | 372be427-acbd-c10c-e063-6294a90a572d | 2025-06-09 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS Pharmacy | d6c8118c-bf78-4194-9b14-8de33c3ecdb7 | 2025-06-06 | Warnings | M013 |
| Dolo-NeuroBion | ACETAMINOPHEN | BENARD INDUSTRIES INC | b8310770-84d1-4a6f-8e23-9974947f92f1 | 2025-06-04 | Warnings | M013 |
| Menstrual Complete Maximum Strength | ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE | Rite Aid Corporation | 69bda7d7-8660-4e8d-b8ac-892a3b1f2124 | 2025-06-03 | Warnings | M013 |
| Kids Pain and Fever | ACETAMINOPHEN | KinderFarms, LLC | fb74e8f9-d72f-4681-90bd-df48364405b5 | 2025-06-01 | Warnings | M013 |
| Pain and Fever Childrens | ACETAMINOPHEN | P & L Development, LLC | b815fcae-8bba-4737-ac10-29a32fb69275 | 2025-05-30 | Warnings | M013 |
| Infants Pain and Fever | ACETAMINOPHEN | KinderFarms, LLC | 81cc4900-226b-4c49-ba9c-5747d2a501b1 | 2025-05-29 | Warnings | M013 |
| good sense pain relief pm extra strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Bryant Ranch Prepack | e08a7ab1-4b68-422a-97bd-2c5326633943 | 2025-05-29 | Warnings | M013 |
| Acetaminophen Gelcaps | ACETAMINOPHEN | Kroger | 30d3f2d0-da35-7f6f-e063-6294a90a9c22 | 2025-05-23 | Warnings | M013 |
| Kids Pain and Fever | ACETAMINOPHEN | Genexa Inc. | fcffa7e6-145c-6bc0-e053-6294a90a4751 | 2025-05-23 | 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 |