Acetaminophen Extra Strength
- Product NDC
- 55319-053
- 11-digit product format
- 553190053
- Labeler code
- 55319
- Product ID
- 55319-053_0bd0c0ce-b9a6-c10e-e063-6394a90a3c77
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Family Dollar Stores, LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-08-11
- 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 Extra Strength
- 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 |
|---|---|
| f86dcbb8-debc-4bce-e053-6294a90a7a02 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-053-14 | Acetaminophen Extra Strength | 50 in 1 BOTTLE | TABLET | 50 | 3 | |
| 55319-053-14 | Acetaminophen Extra Strength | 1 in 1 CARTON | TABLET | 1 | 3 | |
| 55319-053-21 | Acetaminophen Extra Strength | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 55319-053-21 | Acetaminophen Extra Strength | 1 in 1 CARTON | TABLET | 1 | 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 |
|---|---|---|---|---|---|---|
| Bayer Genuine Aspirin | BAYER GENUINE ASPIRIN | Lil' Drug Store Products, Inc. | d17834d7-cb3e-6bf2-e053-2a95a90ae5c1 | 2024-12-30 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN 500 MG, FILM-COATED CAPLET | Lil' Drug Store Products, Inc. | e5fd2b46-683e-4cf5-e053-2995a90a5512 | 2024-12-30 | Warnings | M013 |
| Night Time Severe Cold and Cough Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Chain Drug Consortium, LLC | c8e9b57b-83e9-46c5-9791-02c4c2b94004 | 2024-12-29 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC. | 1608b4f0-bf20-4024-b8f2-20a4df7a4b21 | 2024-12-26 | Warnings | M013 |
| Aspirin | ASPIRIN | Advance Pharmaceutical Inc. | f6a9ea44-08b8-4a33-bfbd-68cb2d852c39 | 2024-12-26 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | cfc7eac3-35be-4002-b8ef-be1dfc8caf69 | 2024-12-26 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | a3031139-4709-43f2-95a8-89840c595f7f | 2024-12-26 | Warnings | M013 |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | WALGREENS CO. | 98bb28ed-d146-ca3d-e053-2a95a90a9eaf | 2024-12-26 | Warnings | M013 |
| Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg | ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG | WALGREENS CO. | 982faa74-d498-cd1e-e053-2995a90afa1e | 2024-12-25 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | AptaPharma Inc. | 11bf6e1b-aed9-4f8f-9f03-ea911ae9f702 | 2024-12-23 | Warnings | M013 |
| Rugby Regular Strength Acetaminophen | ACETAMINOPHEN | RUGBY LABORATORIES | 295b0d00-4d4a-405f-9325-d01c5d4f3ed4 | 2024-12-20 | Warnings | M013 |
| Walgreens Pain Relief Powder | ASPIRIN AND CAFFEINE | Walgreens Co. | 61493d34-2432-4683-9b32-e1851a4337be | 2024-12-18 | Warnings | M013 |
| Reese Headache Powders | ASPIRIN AND CAFFEINE | Reese Pharmaceutical Co | 386f7a6c-4bfc-4140-a67b-07f6b520d58f | 2024-12-18 | Warnings | M013 |
| NobleAid PAIN RELIEVER | ASPIRIN | Noble Otc LLC | aa08e488-2f69-4d7e-86ba-ccfad563edcf | 2024-12-18 | Warnings | M013 |
| Dollar General Headache Powders | ASPIRIN AND CAFFEINE | Dolgencorp, LLC | 11b0271b-d65c-49c4-a081-d71044a0e04c | 2024-12-18 | Warnings | M013 |
| Family Wellness Pain Relief Powder | ASPIRIN AND CAFFEINE | Family Dollar Services Inc | b2e55de7-3c36-49cc-8f7f-1013fd1ec359 | 2024-12-18 | Warnings | M013 |
| Best Choice Pain Relief Powder | ASPIRIN AND CAFFEINE | Value Merch | a95b9b22-ea5c-4a02-b35d-c8ae1e117604 | 2024-12-18 | Warnings | M013 |
| Walmart Pain Relief Powder | ASPIRIN AND CAFFEINE | Walmart | c69aa61f-6a74-40a3-8737-195fa545e261 | 2024-12-18 | Warnings | M013 |
| Quality Choice Pain Relief Powder | ASPIRIN AND CAFFEINE | Chain Drug Marketing Association | 8e1f4057-4968-4523-9b3f-55aea421b674 | 2024-12-18 | Warnings | M013 |
| Equaline Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | United Natural Foods, Inc. dba UNFI | 739237a5-cc62-8ad6-e053-2991aa0a91f8 | 2024-12-17 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | f86dcbb8-debc-4bce-e053-6294a90a7a02 | 3 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | f86dcbb8-debc-4bce-e053-6294a90a7a02 | 3 |
| 198440 | APAP 500 MG Oral Tablet | SY | f86dcbb8-debc-4bce-e053-6294a90a7a02 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55319-053-14 | 55319005314 | 1 BOTTLE in 1 CARTON (55319-053-14) / 50 TABLET in 1 BOTTLE | 1 bottle | 2023-08-11 | No | No | Current |
| 55319-053-21 | 55319005321 | 1 BOTTLE in 1 CARTON (55319-053-21) / 100 TABLET in 1 BOTTLE | 1 bottle | 2023-08-11 | No | No | Current |