Pain Relief Extra Strength
- Product NDC
- 53345-019
- 11-digit product format
- 533450019
- Labeler code
- 53345
- Product ID
- 53345-019_27c7638c-508b-3868-e063-6394a90af73b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-01-06
- 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
- Pain Relief 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 |
|---|---|
| 198439 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5c42dd28-820c-4cc5-9016-11ad5e580616 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53345-019-01 | Pain Relief Extra Strength | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 5 | |
| 53345-019-01 | Pain Relief Extra Strength | 3000 in 1 BAG | CAPSULE, LIQUID FILLED | 3000 | 5 | |
| 53345-019-02 | Pain Relief Extra Strength | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 5 | |
| 53345-019-02 | Pain Relief Extra Strength | 2000 in 1 BAG | CAPSULE, LIQUID FILLED | 2000 | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53345-019 | PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20241127_5c42dd28-820c-4cc5-9016-11ad5e580616.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 |
|---|---|---|---|---|---|---|
| pain relief childrens | ACETAMINOPHEN | Rite Aid Corporation | 29ecdd2d-aeaf-40a8-a347-011088009ea6 | 2026-08-11 | Warnings | M013 |
| Fast Acting Pedia Crae | ACETAMINOPHEN | Randob Labs., Ltd. | e069060f-fbb2-4c7a-b872-00b3ab86d01b | 2026-08-11 | Warnings | M013 |
| ASPIRIN | ASPIRIN | Amazon.com Services LLC | c7cc0681-4c0b-4565-99df-d0168c8ba1ba | 2026-08-10 | Warnings | M013 |
| GenCare Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Pioneer Life Sciences, LLC | ac8c4bdf-30c9-2b09-e053-2a95a90a9b67 | 2026-08-09 | Warnings | M013 |
| Gencare-Aspirin Low Dose Pain reliever (NSAID) | ASPIRIN | Pioneer Life Sciences, LLC | 24d4f46a-c7a5-4e94-804f-1e307d8e8cfc | 2026-08-09 | Warnings | M013 |
| Aspirin 81 mg | ASPIRIN | DOLGENCORP, LLC | b4064039-2345-4227-b83d-54dc13a838d3 | 2026-08-07 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | United Natural Foods, Inc. dba UNFI | 87def9e0-0246-42cf-b8ea-2513d52e9f68 | 2026-08-07 | Warnings | M013 |
| berkley and jensen acetaminophen | ACETAMINOPHEN | BJWC | dee57d73-73ac-48bb-b1da-9971f1ff21c4 | 2026-08-07 | Warnings | M013 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Salado Sales, Inc. | aef30709-f33d-48ff-b2d4-0639ffbd1ffd | 2026-08-07 | Warnings | M013 |
| Aspirin | ASPIRIN | P & L Development, LLC | 4cd74cec-a209-4e92-b853-fbe5c95f7678 | 2026-08-06 | Warnings | M013 |
| Tension Headache Aspirin-Free | ACETAMINOPHEN, CAFFEINE | Rite Aid Corporation | 093a7c26-f2b1-4416-b193-81133d247d2e | 2026-08-06 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | Kroger Company | bc17b2e5-4828-6a2e-e053-2995a90a8c63 | 2026-08-05 | Warnings | M013 |
| Infants TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | 997b9551-c222-4a9c-8ba1-09a5f97495fa | 2026-08-05 | Warnings | M013 |
| Mantra Pain Gel raspberry | ACETAMINOPHEN | MOREMED INC. | 7c8bdf49-a6d2-4e42-b006-375f103fd0ac | 2026-08-05 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | HARRIS TEETER | d2d2846d-4e0b-4d42-b300-60dd3b2cca1b | 2026-08-05 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | HARRIS TEETER | 960f5676-d8c5-470b-a663-4b8d152339b4 | 2026-08-05 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | HARRIS TEETER | a60f6439-2033-4bd2-b78c-6c083414a12b | 2026-08-05 | Warnings | M013 |
| pain relief PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | HARRIS TEETER | 0afb6181-d0b1-4845-8230-faabf1b997dc | 2026-08-05 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | 8a3e3439-90ae-4fc9-8ff2-44b8363fa338 | 2026-08-05 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Harris Teeter | 50e7b939-e0eb-44ea-82ea-034e844e2c29 | 2026-08-05 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198439 | acetaminophen 500 MG Oral Capsule | PSN | 5c42dd28-820c-4cc5-9016-11ad5e580616 | 5 |
| 198439 | acetaminophen 500 MG Oral Capsule | SCD | 5c42dd28-820c-4cc5-9016-11ad5e580616 | 5 |
| 198439 | APAP 500 MG Oral Capsule | SY | 5c42dd28-820c-4cc5-9016-11ad5e580616 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53345-019-01 | 53345001901 | 1 BAG in 1 BOX (53345-019-01) / 3000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2014-01-06 | 0000-00-00 | No | No | Current |
| 53345-019-02 | 53345001902 | 1 BAG in 1 BOX (53345-019-02) / 2000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2014-01-06 | 0000-00-00 | No | No | Current |