Pain Reliever
- Product NDC
- 68016-543
- 11-digit product format
- 680160543
- Labeler code
- 68016
- Product ID
- 68016-543_913edec4-45ba-48bd-8da0-23f38da8fd6a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chain Drug Consortium
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-04-29
- Marketing end
- 2026-11-30
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- 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
- Pain Reliever
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 |
|---|---|
| 60d4b392-6ed0-4115-8154-24eaf72504a5 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-543-01 | Pain Reliever | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | 5 | |
| 68016-543-01 | Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 68016-543-24 | Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 68016-543-24 | Pain Reliever | 24 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 24 | 5 | |
| 68016-543-99 | Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 68016-543-99 | Pain Reliever | 225 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 225 | 5 |
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 |
|---|---|---|---|---|---|---|
| Pain Relief Extra Strength | ACETAMINOPHEN | DISCOUNT DRUG MART | e6fee238-0b6f-cb84-e053-2995a90a361b | 2024-12-05 | Warnings | M013 |
| Menstrual Complete Maximum Strength | ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE | L.N.K. International, Inc. | 379ef03c-3b6a-40c3-b736-99f0537d26c8 | 2024-12-05 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | Marc Glassman, Inc. | 43bf297f-2832-424f-a013-4bfa1d6c03e6 | 2024-12-04 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Precision Dose, Inc. | 5a68ab98-720c-479a-a60a-4e594add6c09 | 2024-12-04 | Warnings | M013 |
| HEB Effervescent Pain Relief | ASPIRIN | H. E. BUTT GROCERY COMPANY | 03876c71-60ec-3280-e063-6294a90a62dc | 2024-12-03 | Warnings | M013 |
| Migrafein FORTE | ACETAMINOPHEN, CAFFEINE | OPMX LLC | 028875c9-4129-ce2c-e063-6294a90a26cc | 2024-12-03 | Warnings | M013 |
| Neo-Lubrina Fuerte | ACETAMINOPHEN, CAFFEINE | OPMX LLC | 0288a327-fd4b-1991-e063-6294a90ace50 | 2024-12-03 | Warnings | M013 |
| CAFIZETAMOL FORTE | ACETAMINOPHEN, CAFFEINE | OPMX LLC | 028771d3-a514-f7a5-e063-6394a90ac4f3 | 2024-12-03 | Warnings | M013 |
| Buscapina | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | OPMX LLC | 048c4b03-1cf4-b724-e063-6294a90a1cad | 2024-12-03 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | TopCo Associates LLC | ecd6df7e-e7e2-446b-85ef-25971281fe31 | 2024-12-03 | Warnings | M013 |
| Market Basket Effervescent Pain Relief | ASPIRIN | DEMOULAS SUPER MARKETS, INC. | 08133bf0-3c8f-e4d0-e063-6294a90af79a | 2024-12-03 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | WinCo Foods, LLC | 4359da13-e851-440b-91b9-6b544bff20d2 | 2024-12-03 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | WinCo Foods, LLC | 5b3e8a78-5357-42ad-811e-b2578b25dc7b | 2024-12-03 | Warnings | M013 |
| Low Strength Chewable Aspirin | ASPIRIN | Geri-Care Pharmaceutical Corp | cc77b9d1-7874-4ce8-a763-3a0e1c2891de | 2024-12-03 | Warnings | M013 |
| Good Sense Childrens Pain and Fever | ACETAMINOPHEN | L. Perrigo Company | c6b79501-d08b-4430-9545-70da5f545975 | 2024-12-03 | Warnings | M013 |
| Aspirin | ASPIRIN | Chain Drug Marketing Association | 0e3be5f4-bc1b-4b44-a86a-ace89f6ee592 | 2024-12-02 | Warnings | M013 |
| St. Joseph Chewable Low Dose Aspirin | ASPIRIN | Foundation Consumer Healthcare LLC | 248cd302-e380-4837-bdae-9df620b67e8a | 2024-12-02 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | AAA Pharmaceutical, Inc. | 2d98e390-4f2a-41cc-b307-3d2f6a3700dd | 2024-12-02 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | AAA Pharmaceutical, Inc. | 409b5fcd-5880-4dda-85d8-26aeceb4f8ab | 2024-12-02 | Warnings | M013 |
| Aspirin | ASPIRIN | AAA Pharmaceutical, Inc. | c0c31523-c4c5-43c2-8d72-4d1456c720e9 | 2024-12-02 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 60d4b392-6ed0-4115-8154-24eaf72504a5 | 5 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 60d4b392-6ed0-4115-8154-24eaf72504a5 | 5 |
| 198440 | APAP 500 MG Oral Tablet | SY | 60d4b392-6ed0-4115-8154-24eaf72504a5 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68016-543-01 | 68016054301 | 1 BOTTLE, PLASTIC in 1 CARTON (68016-543-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2022-04-29 | 2026-11-30 | No | No | Current |
| 68016-543-24 | 68016054324 | 1 BOTTLE, PLASTIC in 1 CARTON (68016-543-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2022-04-29 | 2026-11-30 | No | No | Current |
| 68016-543-99 | 68016054399 | 1 BOTTLE, PLASTIC in 1 CARTON (68016-543-99) / 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2022-04-29 | 2026-11-30 | No | No | Historical |