Headache Relief
- Product NDC
- 63868-485
- 11-digit product format
- 638680485
- Labeler code
- 63868
- Product ID
- 63868-485_db6c7572-59e0-4734-bfd6-1117dad5dd1b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin and caffeine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- CHAIN DRUG MARKETING ASSOCIATION INC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1992-11-17
- Marketing end
- 2027-03-31
- Substance
- ACETAMINOPHEN; ASPIRIN; CAFFEINE
- Active strength
- 250; 250; 65 mg/1; mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
- NDC exclude flag
- No
- 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 | 63868-485 | 63868-485-02 | D | Discontinued by firm | 2026-10-21 |
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
- Headache Relief
- Brand name suffix
- Extra Strength
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 250 mg/1 |
| ASPIRIN | 250 mg/1 |
| CAFFEINE | 65 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| R16CO5Y76E | Internal UNII lookup |
| 3G6A5W338E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 308297 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4005f8dd-3050-4590-8703-6997444e8df3 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-485-01 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 30 | |
| 63868-485-01 | Headache ReliefExtra Strength | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | 30 | |
| 63868-485-02 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 30 | |
| 63868-485-02 | Headache ReliefExtra Strength | 200 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 200 | 30 | |
| 63868-485-24 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 30 | |
| 63868-485-24 | Headache ReliefExtra Strength | 24 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 24 | 30 | |
| 63868-485-50 | Headache ReliefExtra Strength | 50 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 50 | 30 | |
| 63868-485-50 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 30 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-485-01 | EA - Each | 63868-485 | 716fc68f-d537-4ab9-8fdc-fc1442f50b53 | 1 | 2012-07-24 |
| 63868-485-24 | EA - Each | 63868-485 | 3589439d-c046-42eb-980e-c5f94fe79d38 | 1 | 2022-10-06 |
| 63868-485-50 | EA - Each | 63868-485 | e70cc807-5ef7-44c7-8d3a-896a96bbc07d | 1 | 2022-10-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63868-485 | HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] | 29 | Current NDC, Legacy NDC, 8 package rows | 20240709_4005f8dd-3050-4590-8703-6997444e8df3.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 Extra Strength | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 5c42dd28-820c-4cc5-9016-11ad5e580616 | 2024-11-25 | Warnings | M013 |
| equate pain reliever | ACETAMINOPHEN | WALMART INC. | 4518fe82-3ba8-4e9e-a036-776df7fb8d57 | 2024-11-21 | Warnings | M013 |
| Family Wellness Pain Reliever | ASPIRIN | FAMILY WELLNESS SERVICES, INC. | 075e19f4-1a58-aedd-e063-6294a90af708 | 2024-11-20 | Warnings | M013 |
| Mejoralito | ACETAMINOPHEN | OPMX Chula Vista | fd2ecde0-296e-060f-e053-6294a90afd98 | 2024-11-15 | Warnings | M013 |
| Temp X | ACETAMINOPHEN | OPMX Chula Vista | fd2edc32-0351-c991-e053-6294a90ab4ce | 2024-11-15 | Warnings | M013 |
| CVS Health Extra Strength Antacid and Pain Reliever | ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE | CVS Pharmacy | afe9e755-18ba-305f-e053-2995a90aa8d0 | 2024-11-14 | Warnings | M013 |
| Walgreens Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Walgreens | 667418fc-a3ab-cbc7-e053-2a91aa0a2023 | 2024-11-13 | Warnings | M013 |
| Up and Up Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Target Corporation | a72eef45-b985-638a-e053-2995a90aa20a | 2024-11-13 | Warnings | M013 |
| Signature Care Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Safeway, Inc | 6e120024-475a-73af-e053-2a91aa0a42a6 | 2024-11-13 | Warnings, Adverse reactions | M013 |
| Kroger Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Kroger Company | 6d858b0e-a3c8-2686-e053-2991aa0acc06 | 2024-11-13 | Warnings | M013 |
| TopCare Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Topco Associates LLC | 639f9d57-f26a-708a-e053-2a91aa0a6962 | 2024-11-13 | Warnings, Adverse reactions | M013 |
| Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | H. E. Butt Grocery Company | 6418cde9-607b-4ca1-e053-2991aa0a9170 | 2024-11-13 | Warnings | M013 |
| Bromo Seltzer | ASPIRIN, SODIUM BICARBONATE, CITRIC ACID | Tower Laboratories Ltd | 8ff88ee1-e33e-4051-992f-24e2720c48ce | 2024-11-13 | Warnings | M013 |
| Care One Original Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Foodhold U.S.A. | 8f662c51-d2fa-6458-e053-2995a90ac6fd | 2024-11-13 | Warnings | M013 |
| Top Value Effervescent Pain Relief | APIRIN, CITRIC ACID, SODIUM BICARBONATE | Tower Laboratories Ltd | 43c7f435-735c-3fab-e054-00144ff88e88 | 2024-11-13 | Warnings, Adverse reactions | M013 |
| DG Health Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | DOLGENCORP, INC | 8f1343d5-2884-3a14-e053-2a95a90a2f90 | 2024-11-13 | Warnings | M013 |
| Good Sense Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Good Sense | cd25b0c3-0134-beef-e053-2a95a90a092b | 2024-11-13 | Warnings | M013 |
| Drug Mart Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Discount Drug Mart, Inc | 8bc65603-1dbf-30ab-e053-2995a90a7c15 | 2024-11-13 | Warnings | M013 |
| Best Choice Effervescent Antacid Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Valu Merchandisers Company | 8aab905b-5fe7-dddb-e053-2995a90a6c6f | 2024-11-13 | Warnings | M013 |
| Publix Fast Relief Effervescent | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Publix Super Markets Inc. | 73051f16-2569-7394-e053-2991aa0a5359 | 2024-11-13 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | PSN | 4005f8dd-3050-4590-8703-6997444e8df3 | 30 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 4005f8dd-3050-4590-8703-6997444e8df3 | 30 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 4005f8dd-3050-4590-8703-6997444e8df3 | 30 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63868-485-01 | 63868048501 | 1 BOTTLE, PLASTIC in 1 CARTON (63868-485-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 1992-11-17 | 2027-03-31 | No | No | Current |
| 63868-485-02 | 63868048502 | 1 in 1 CARTON | Historical | ||||
| 63868-485-24 | 63868048524 | 1 BOTTLE, PLASTIC in 1 CARTON (63868-485-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 1992-11-17 | 2027-03-31 | No | No | Current |
| 63868-485-50 | 63868048550 | 1 BOTTLE, PLASTIC in 1 CARTON (63868-485-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 1992-11-17 | 2027-03-31 | No | No | Current |