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 | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1c083e29-8732-4ecd-ab4b-9038acbd0b9d | 2025-05-22 | Warnings | M013 |
| TYLENOL For Children Plus Adults | ACETAMINOPHEN | Kenvue Brands LLC | 5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42 | 2025-05-21 | Warnings | M013 |
| Children Acetaminophen | ACETAMINOPHEN | AARNA USA INC. | 25bcb9d5-f388-4ae7-8037-970ffe8d17f0 | 2025-05-16 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | HF Acquisition Co LLC, DBA HealthFirst | 35478de8-50d0-5d0a-e063-6294a90a88ba | 2025-05-16 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | 95f4b628-6d35-4f6b-91f9-b2d117f8e821 | 2025-05-16 | Warnings | M013 |
| good neighbor pharmacy childrens pain and fever | ACETAMINOPHEN | Amerisource Bergen | 268a789b-8f31-4739-9777-523249cac326 | 2025-05-13 | Warnings | M013 |
| ASPIRIN LOW DOSE | ASPIRIN LOW DOSE | AARNA USA INC. | 347edc8f-6391-b75e-e063-6394a90a1cf5 | 2025-05-06 | Warnings | M013 |
| Good Neighbor Pharmacy Infants Pain and Fever | ACETAMINOPHEN | Amerisource Bergen | 2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb2 | 2025-05-06 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | AARNA USA INC. | 34157f6a-3031-4388-e063-6394a90a670f | 2025-05-01 | Warnings | M013 |
| ASPIRIN | ASPIRIN | HF Acquisition Co LLC, DBA HealthFirst | 2553d0cb-3f5c-7ea0-e063-6294a90a3cd4 | 2025-05-01 | Warnings, Adverse reactions | M013 |
| Aspirin 81mg Enteric Coated | ASPIRIN | Advanced Rx LLC | 606067bb-b07f-444e-9465-d1e187735f3a | 2025-05-01 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | AARNA USA INC. | 33f0e822-28af-9bb2-e063-6294a90a5175 | 2025-04-29 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 27fcca07-f845-77fe-e063-6394a90aa2f8 | 2025-04-24 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 46a6bbb9-ccd1-47a8-9e58-485f71f57063 | 2025-04-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | 061c91d5-5aa8-4556-a344-197b7e8a10b8 | 2025-04-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | A-S Medication Solutions | c4f0f591-8501-4c6d-bf8e-ca3068ff65b5 | 2025-04-24 | Warnings | M013 |
| Extra Strength No-Pain | ACETAMINOPHEN | Safrel Pharmaceuticals, LLC. | 873f01dd-0701-5fd3-e053-2a95a90a6463 | 2025-04-23 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Chain Drug Consortium | 60d4b392-6ed0-4115-8154-24eaf72504a5 | 2025-04-16 | Warnings | M013 |
| Premsyn pms Premenstrual Pain Relief | ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE | Focus Consumer Healthcare, LLC | 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | 2025-04-14 | Warnings | M013 |
| BackAid Max | ACETAMINOPHEN, PAMABROM | Kobayashi Healthcare International, Inc. | fb9a5647-b7c9-4820-b148-91060e34cb83 | 2025-04-14 | 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 |