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 |
|---|---|---|---|---|---|---|
| good sense pain relief | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 3c1f505d-0319-a179-e063-6294a90a0b17 | 2025-08-11 | Warnings | M013 |
| Aspirin | ASPIRIN | PROSTAT FIRST AID | 3bdb9d89-9000-69f9-e063-6294a90a0c97 | 2025-08-08 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Prostat First Aid | 3bdbea6a-3f11-9142-e063-6294a90a20ea | 2025-08-08 | Warnings | M013 |
| Aspi-Cor | ASPIRIN | L.N.K. International, Inc. | 9f919a48-ffd8-49fa-b6fd-ec71cc12e64b | 2025-08-08 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | A-S Medication Solutions | 8575ef9d-2eae-412a-a252-82b03f4d5275 | 2025-08-08 | Warnings | M013 |
| Aspirin | ASPIRIN | A-S Medication Solutions | 7a91b1df-8d6d-4205-9822-bc4d800555f7 | 2025-08-08 | Warnings | M013 |
| M-PAP | ACETAMINOPHEN | Bryant Ranch Prepack | 3d6bf733-800c-420a-a9ab-ae4a26134799 | 2025-08-08 | Warnings | M013 |
| Aspirin | ASPIRIN | A-S Medication Solutions | 44b8c203-37c5-425e-9110-f7eb614f9c2d | 2025-08-08 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION INC | c46688ec-e976-4f76-9265-645f59970ff5 | 2025-08-06 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | P & L Development, LLC | c54ad829-f2e8-4367-b439-af20b0ef8ad2 | 2025-08-06 | Warnings | M013 |
| TYLENOL Regular Strength | ACETAMINOPHEN | Kenvue Brands LLC | 398d8996-b522-a3cd-e063-6394a90ac2c8 | 2025-08-06 | Warnings | M013 |
| Aspirin | ASPIRIN | Marlex Pharmaceuticals Inc. | cc7013ea-cf30-6f59-e053-2a95a90a1148 | 2025-08-05 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Prostat First Aid | 3ba313db-bafe-1947-e063-6294a90a528c | 2025-08-05 | Warnings | M013 |
| MEDIQUE APAP acetaminophen | MEDIQUE APAP ACETAMINOPHEN | HF Acquisition Co LLC, DBA HealthFirst | 3ba5c802-fe5a-e42a-e063-6394a90ae67e | 2025-08-05 | Warnings | M013 |
| meijer EXTRA STRENGTH Pain Relief PM CAPLET | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Meijer, Inc. | 376fed3b-7625-6379-e063-6394a90a188d | 2025-08-05 | Warnings | M013 |
| CAREONE INFANTS ACETAMINOPHEN | ACETAMINOPHEN | Retail Business Services, LLC | b8024ec2-97c6-4aa1-b1dd-894164f48811 | 2025-08-04 | Warnings | M013 |
| Exaprin Plus | ASPIRIN, ACETAMINOPHEN, CAFFEINE | HART Health | 8a9ca680-e6cf-4ee4-8a5f-bd6d7470b848 | 2025-08-04 | Warnings | M013 |
| Aspirin | ASPIRIN | Proficient Rx LP | 2ef0757a-fe5f-47de-906a-a4d47a0d0534 | 2025-08-01 | Warnings | M013 |
| Good Sense Pain Relief | ACETAMINOPHEN | Proficient Rx LP | b4cb4a62-9ef7-4185-8770-e9a806c2fb3f | 2025-08-01 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | AAA Pharmaceutical, Inc. | 36ad21a3-6229-e91b-e063-6394a90a7933 | 2025-07-29 | 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 |