Pain Relief
- Product NDC
- 53943-304
- 11-digit product format
- 539430304
- Labeler code
- 53943
- Product ID
- 53943-304_288998e3-a490-9c47-e063-6394a90ae9aa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- DISCOUNT DRUG MART
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-01-05
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 53943-304 | 53943-304-02 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 53943-304 | 53943-304-04 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 53943-304 | 53943-304-09 | D | Discontinued by firm | 2026-10-23 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 53943-304-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 53943-304-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 53943-304-09 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 53943-304-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 53943-304-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 53943-304-09 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 53943-304-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 53943-304-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 53943-304-09 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 53943-304-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 53943-304-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 53943-304-09 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 53943-304-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 53943-304-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 53943-304-09 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 53943-304-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 53943-304-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 53943-304-09 | cdf11ea48f46… | ba0047e9e063… |
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
- 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 |
|---|---|
| 198440 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 972f09a7-2aa1-4b1b-a6dc-2c4578a07803 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53943-304-02 | Pain Relief | 50 in 1 BOTTLE, PLASTIC | TABLET, COATED | 50 | 5 | |
| 53943-304-02 | Pain Relief | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 53943-304-04 | Pain Relief | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 53943-304-04 | Pain Relief | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 5 | |
| 53943-304-06 | Pain Relief | 500 in 1 BOTTLE, PLASTIC | TABLET, COATED | 500 | 5 | |
| 53943-304-09 | Pain Relief | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 5 | |
| 53943-304-09 | Pain Relief | 2 in 1 CARTON | TABLET, COATED | 2 | 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 |
|---|---|---|---|---|---|---|
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Proficient Rx LP | af8b30a0-7a56-4557-8404-cc8059fcd6bc | 2023-11-01 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | AMERIFOODS TRADING COMPANY | f6dd387d-c768-9443-e053-6394a90aca14 | 2023-10-31 | Warnings | M013 |
| ASPIRIN | ASPIRIN | AMERIFOODS TRADING COMPANY | f6cec280-17a5-5c5d-e053-6394a90a81aa | 2023-10-31 | Warnings | M013 |
| Regular Strength Aspirin | ASPIRIN | CARDINAL HEALTH, INC. | 8aaa82c6-b46b-25c5-e053-2a95a90a3793 | 2023-10-30 | Warnings | M013 |
| SafeTynadol | ACETAMINOPHEN | Sinew Pharma Inc. | b956d527-7ea7-e084-e053-2a95a90a866d | 2023-10-28 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Magno-Humphries, Inc. | 9d2275c8-0c3d-d2b3-e053-2995a90a368e | 2023-10-27 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Magno-Humphries, Inc. | 9d22bedb-9fb3-8421-e053-2a95a90acf4a | 2023-10-27 | Warnings | M013 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | Magno-Humphries, Inc. | 9d22d642-8aaf-d17e-e053-2995a90ae182 | 2023-10-27 | Warnings | M013 |
| ENTERIC COATED ASPIRIN | ASPIRIN | Magno-Humphries, Inc. | a7c02378-4213-4e57-aca2-2437ad02f786 | 2023-10-27 | Warnings | M013 |
| Extraprin | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Magno-Humphries, Inc. | 9d22cdc8-29c5-4273-e053-2a95a90ad0bf | 2023-10-27 | Warnings | M013 |
| Regular Strength Enteric coated aspirin | ASPIRIN | Geri-Care Pharmaceutical Corp | c321208c-f192-42c5-9454-e0df5d02d685 | 2023-10-26 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALGREENS | f3c69974-7f51-2227-e053-2995a90a5570 | 2023-10-21 | Warnings | M013 |
| Menstrual Complete | MENSTRUAL COMPLETE | Healthlife of USA | c7e89b01-a8eb-4487-8f0b-a4b9ae6d9f33 | 2023-10-21 | Warnings | M013 |
| Extra Strength Pain Relief | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | e65dbd01-2d5e-4067-ad98-98d879cfb5ee | 2023-10-19 | Warnings | M013 |
| Regular Strength Pain Reliever | ACETAMINOPHEN | INGLES MARKETS, INC. | f06fe167-8a16-14d9-e053-2a95a90a1a0f | 2023-10-17 | Warnings | M013 |
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | BLESSINGS INTERNATIONAL | ee8ba190-2c42-7ca2-e053-2a95a90a01a0 | 2023-10-17 | Warnings | M013 |
| Aphen | ACETAMINOPHEN | Asclemed USA, Inc. | fe3c0a2b-316b-4620-b6bc-378dbaf7ed57 | 2023-10-16 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | Walgreens | b4b06d32-6a09-4c43-980b-377b617ba739 | 2023-10-09 | Warnings | M013 |
| FLO PMS Complete | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | O Positiv, Inc. | cce62d9f-adb1-4473-8258-910dff6b1378 | 2023-10-09 | Warnings | M013 |
| childrens mapap | ACETAMINOPHEN | Proficient Rx LP | 88c4183a-3032-46de-bf18-f700055f617b | 2023-10-01 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 972f09a7-2aa1-4b1b-a6dc-2c4578a07803 | 5 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 972f09a7-2aa1-4b1b-a6dc-2c4578a07803 | 5 |
| 198440 | APAP 500 MG Oral Tablet | SY | 972f09a7-2aa1-4b1b-a6dc-2c4578a07803 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53943-304-02 | 53943030402 | 1 BOTTLE, PLASTIC in 1 CARTON (53943-304-02) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC | 2010-01-05 | 0000-00-00 | No | No | Current |
| 53943-304-04 | 53943030404 | 1 BOTTLE, PLASTIC in 1 CARTON (53943-304-04) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2010-03-04 | 0000-00-00 | No | No | Current |
| 53943-304-06 | 53943030406 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (53943-304-06) | 2010-01-05 | 0000-00-00 | No | No | Current |
| 53943-304-09 | 53943030409 | 2 BOTTLE, PLASTIC in 1 CARTON (53943-304-09) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2013-04-04 | 0000-00-00 | No | No | Current |