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 |
|---|---|---|---|---|---|---|
| topcare infants pain and fever | ACETAMINOPHEN | Topco Associates LLC | a1145ac3-3e55-4bd5-a53e-6cf869add9a1 | 2024-07-02 | Warnings | M013 |
| Drug Mart Effervescent Pain Relief | ASPIRIN | Discount Drug Mart Inc | 1c35f394-a221-6531-e063-6394a90acb8a | 2024-07-01 | Warnings | M013 |
| Aspirin | ASPIRIN | Wildman Business Group | cdbfcf14-8685-40a9-9778-a3b4329dc1ad | 2024-07-01 | Warnings | M013 |
| Back Pain Relief Extra Strength Doans | MAGNESIUM SALICYLATE | Wildman Business Group | 2e17664f-a83f-48d1-8b2b-37f41eea65b6 | 2024-07-01 | Warnings | M013 |
| Meijer Effervescent Pain Relief | ASPIRIN | Meijer Distribution Inc | 17553911-e0fc-e355-e063-6394a90af7b8 | 2024-06-28 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 4fb4f4b2-c238-4933-b874-08def3b34a28 | 2024-06-26 | Warnings | M013 |
| good neighbor pharmacy pain and fever childrens | ACETAMINOPHEN | Amerisource Bergen | ca0833ef-837b-47dc-8676-e016af96622c | 2024-06-26 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 4a030c3e-8104-4a0a-98c5-6ab469451f20 | 2024-06-26 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | Padagis Israel Pharmaceuticals Ltd | a426dd82-b2d6-405e-b0af-cfb1310a6e19 | 2024-06-26 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALMART INC. (see also Equate) | 7d86a03f-74f4-4b24-b6a6-8747acfe905e | 2024-06-26 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 5bcc5da9-7e64-4308-a5be-2f47a8ca774d | 2024-06-25 | Warnings | M013 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | NuCare Pharmaceuticals,Inc. | 9e691264-d48a-6b48-e053-2995a90a9352 | 2024-06-20 | Warnings | M013 |
| Aspirin | REGULAR STRENGTH ENTERIC COATED ASPIRIN | NuCare Pharmceuticals,Inc. | a0705f4f-55cb-214a-e053-2995a90aa680 | 2024-06-20 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN 500 MG | Lil' Drug Store Products, Inc. | ee8e0e79-4da4-101f-e053-2a95a90a30a4 | 2024-06-19 | Warnings | M013 |
| Extra Strength Headache Relief | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Lil' Drug Store Products, Inc. | b3a06e4b-0b31-4e2a-8dd1-9de85760477b | 2024-06-19 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | Meijer Distribution Inc | 43c3fe72-a4ef-48a6-bc22-a644919c0c5c | 2024-06-17 | Warnings | M013 |
| Aspirin Regular Strength | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | 093182a6-3ed8-5a3f-e063-6294a90a354a | 2024-06-14 | Warnings | M013 |
| ACETAMINOPHEN PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 093199be-e92a-6f60-e063-6294a90a8533 | 2024-06-14 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | RETAIL BUSINESS SERVICES , LLC. | 09315a3d-bb2d-4f06-e063-6294a90a3bd3 | 2024-06-14 | Warnings | M013 |
| Pain Relief Regular Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | 613bc633-0426-41a7-aea9-9ff56311b607 | 2024-06-13 | 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 |