Pain Relief
- Product NDC
- 63868-084
- 11-digit product format
- 638680084
- Labeler code
- 63868
- Product ID
- 63868-084_243531d9-3c42-d20a-e063-6294a90a2b09
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-06-13
- 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 | 63868-084 | 63868-084-10 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 63868-084 | 63868-084-20 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 63868-084 | 63868-084-24 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 63868-084 | 63868-084-50 | D | Discontinued by firm | 2026-10-20 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Brand name suffix
- 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 |
|---|---|
| 198440 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 68a52858-35c5-402a-8ceb-8d8a7c1e5f6c | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-084-05 | Pain ReliefExtra Strength | 500 in 1 BOTTLE, PLASTIC | TABLET, COATED | 500 | 5 | |
| 63868-084-10 | Pain ReliefExtra Strength | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 5 | |
| 63868-084-10 | Pain ReliefExtra Strength | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 63868-084-20 | Pain ReliefExtra Strength | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 5 | |
| 63868-084-20 | Pain ReliefExtra Strength | 2 in 1 CARTON | TABLET, COATED | 2 | 5 | |
| 63868-084-24 | Pain ReliefExtra Strength | 24 in 1 BOTTLE, PLASTIC | TABLET, COATED | 24 | 5 | |
| 63868-084-24 | Pain ReliefExtra Strength | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 63868-084-50 | Pain ReliefExtra Strength | 1 in 1 CARTON | TABLET, COATED | 1 | 5 | |
| 63868-084-50 | Pain ReliefExtra Strength | 50 in 1 BOTTLE, PLASTIC | TABLET, COATED | 50 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-084-05 | EA - Each | 63868-084 | 047c6c6e-26bd-41bb-8750-06ef044c203e | 1 | 2019-08-06 |
| 63868-084-10 | EA - Each | 63868-084 | 99f880e3-f152-4275-b7f0-3d3c194853a4 | 1 | 2020-03-10 |
| 63868-084-24 | EA - Each | 63868-084 | cfc2bdbf-80de-46fe-a6cf-f67889886cc2 | 1 | 2020-04-20 |
| 63868-084-50 | EA - Each | 63868-084 | 1714a893-18f4-4100-a4c5-afff5894cacf | 1 | 2018-07-03 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Equaline Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | United Natural Foods, Inc. dba UNFI | 739237a5-cc62-8ad6-e053-2991aa0a91f8 | 2024-12-17 | Warnings | M013 |
| NOTTS - Muscle Aches and Pain | ACETAMINOPHEN | VIVUNT PHARMA LLC | e6741300-4573-2580-e053-2a95a90a599c | 2024-12-17 | Warnings | M013 |
| Extra Strength Pain Reliever, Caseys 4good | ACETAMINOPHEN 500MG, FILM-COATED CAPLET | Lil' Drug Store Products, Inc. | e5fc5340-c224-e02b-e053-2a95a90a5297 | 2024-12-16 | Warnings | M013 |
| Pain Reliever, Caseys 4good | ACETAMINOPHEN 500 MG, TABLET | Lil' Drug Store Products, Inc. | 039d2cf1-57f6-4d9d-e063-6394a90a5492 | 2024-12-16 | Warnings | M013 |
| Extra Strength Headache, Caseys 4good | ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET | Lil' Drug Store Products, Inc. | 0425c6a8-a3ea-24ad-e063-6294a90ae15a | 2024-12-16 | Warnings | M013 |
| Lil Drug Store Childrens Pain and Fever | ACETAMINOPHEN | Lil' Drug Store Products, Inc. | 5fcd41ad-449f-4090-be19-eae4171de891 | 2024-12-16 | Warnings | M013 |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | CVS Pharmacy | b9e75551-1e50-9896-e053-2a95a90aafd4 | 2024-12-14 | Warnings | M013 |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | CVS Pharmacy | b9e5df0e-06d3-6f72-e053-2995a90a2d07 | 2024-12-14 | Warnings | M013 |
| Alka-Seltzer Heartburn and Pain | ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE | Bayer HealthCare LLC. | 2928e140-c868-5bf5-e063-6394a90ab024 | 2024-12-13 | Warnings | M013 |
| foster and thrive pain reliever | ACETAMINOPHEN | Strategic Sourcing Services LLC | b8ee568c-80cf-4e35-865e-35516bdab0fd | 2024-12-13 | Warnings | M013 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strive Pharmaceuticals Inc. | c0de0bd2-4868-46dc-a20f-3ca02caaa26b | 2024-12-11 | Warnings | M013 |
| Rite Aid Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Rite Aid | b4797380-9cef-d640-e053-2a95a90a0665 | 2024-12-11 | Warnings | M013 |
| Top Value Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICAROBONATE | Tower Laboratories Ltd | 44babed8-cf38-1c12-e054-00144ff8d46c | 2024-12-11 | Warnings, Adverse reactions | M013 |
| Best Choice Effervescent Antacid Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Valu Merchandisers Company | b5e2300a-b77b-53cc-e053-2a95a90a7a6e | 2024-12-11 | Warnings | M013 |
| EXTRA STRENGTH Headache Relief geltabs | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strive Pharmaceuticals Inc. | b432771a-4f7d-4d39-a038-d1561d8f6708 | 2024-12-11 | Warnings | M013 |
| Pain Relief Childrens | ACETAMINOPHEN | QUALITY CHOICE (Chain Drug Marketing Association) | 223ffb2b-3ee5-4118-955b-bc4fa4e8a2e6 | 2024-12-10 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | UNFI | e689c9e3-dd4d-c646-e053-2a95a90a4b6a | 2024-12-09 | Warnings | M013 |
| DrKids Childrens Pain and Fever | ACETAMINOPHEN 80MG/PIECE | CalmCo LLC | ff4b0528-39a0-80d5-e053-6394a90a8a83 | 2024-12-07 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 972f09a7-2aa1-4b1b-a6dc-2c4578a07803 | 2024-12-05 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | DISCOUNT DRUG MART | e6feff0a-3347-194d-e053-2a95a90acd20 | 2024-12-05 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 68a52858-35c5-402a-8ceb-8d8a7c1e5f6c | 5 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 68a52858-35c5-402a-8ceb-8d8a7c1e5f6c | 5 |
| 198440 | APAP 500 MG Oral Tablet | SY | 68a52858-35c5-402a-8ceb-8d8a7c1e5f6c | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63868-084-05 | 63868008405 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (63868-084-05) | 2014-06-13 | 0000-00-00 | No | No | Current |
| 63868-084-10 | 63868008410 | 1 BOTTLE, PLASTIC in 1 CARTON (63868-084-10) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC | 2014-06-13 | 0000-00-00 | No | No | Current |
| 63868-084-20 | 63868008420 | 100 in 1 BOTTLE, PLASTIC | Historical | ||||
| 63868-084-24 | 63868008424 | 1 BOTTLE, PLASTIC in 1 CARTON (63868-084-24) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC | 2014-06-13 | 0000-00-00 | No | No | Current |
| 63868-084-50 | 63868008450 | 1 BOTTLE, PLASTIC in 1 CARTON (63868-084-50) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC | 2014-06-13 | 0000-00-00 | No | No | Current |