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 |
|---|---|---|---|---|---|---|
| Pain Relief Extra Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 9fdbaf5e-f88b-4d18-97df-0b2e8dddf377 | 2024-06-13 | Warnings | M013 |
| Aspirin 81 mg Low dose | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | bfb9af64-3195-44bf-bcf3-6b36b40d3cc7 | 2024-06-13 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1ac7ed71-5afe-d09c-e063-6294a90a3b88 | 2024-06-13 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 3ce5bbf2-d449-464e-abeb-5c26866d1ab5 | 2024-06-13 | Warnings | M013 |
| Aspirin | ASPIRIN | AAA Pharmaceutical, Inc. | 609948d6-0f20-4d0c-adc0-6ae72a4f2b7a | 2024-06-13 | Warnings | M013 |
| Aspirin | ASPIRIN | AAA Pharmaceutical, Inc. | 3f73a359-59d7-47bb-872e-914b0db719af | 2024-06-13 | Warnings | M013 |
| topcare infants pain and fever | ACETAMINOPHEN | Topco Associates LLC | f1e940ef-3cf0-4a5c-8158-156d0e5a680d | 2024-06-13 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Trifecta Pharmaceuticals USA LLC | 026bf664-d598-73de-e063-6394a90a9206 | 2024-06-12 | Warnings | M013 |
| Regular Strength Pain Relief | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 7c73fc75-af9b-177c-e053-2a91aa0ada56 | 2024-06-12 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | Topco Associates | 4a6a1dbb-c813-42fd-9bb8-497aec339466 | 2024-06-11 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | fa234639-caf8-4c52-9ffe-f1c0c057ee5b | 2024-06-10 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | bc18590d-6481-4efe-8a3b-974f7543b754 | 2024-06-10 | Warnings | M013 |
| ASPIRIN | ASPIRIN | H-E-B | 085b35db-62e4-38db-e063-6394a90a9763 | 2024-06-07 | Warnings | M013 |
| pain and fever | ACETAMINOPHEN | Meijer Distribution Inc | cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf | 2024-06-07 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | 5691ac45-5732-412e-abb8-2bfaac59160e | 2024-06-07 | Warnings | M013 |
| Cafiaspirina Rapid Headache Relief | ASPIRIN, CAFFEINE | Belmora LLC | d890acec-6528-4fb7-8d59-6c572a3f0786 | 2024-06-07 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | TARGET Corporation | 611bc1ce-460a-44a3-8e2d-b28a399d9a44 | 2024-06-06 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Meijer Distribution Inc | 033a6153-2651-4703-8a94-def461838113 | 2024-06-05 | Warnings | M013 |
| CareOne Childrens Acetaminophen | ACETAMINOPHEN | American Sales Company | 126ee71a-c408-415b-9a43-502337a91055 | 2024-06-05 | Warnings | M013 |
| Tylenol Extra Strength | ACETAMINOPHEN | A-S Medication Solutions | 85294a70-3233-4ba5-bc36-ee3f2964aebf | 2024-06-05 | 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 |