Headache Relief
- Product NDC
- 59779-334
- 11-digit product format
- 597790334
- Labeler code
- 59779
- Product ID
- 59779-334_bb9d51b6-46a6-4239-97db-392a44755857
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin and Caffeine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2008-03-13
- 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
- Listing certified through
- 2027-12-31
- 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 | 59779-334 | 59779-334-06 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 59779-334 | 59779-334-07 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 59779-334 | 59779-334-12 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 59779-334 | 59779-334-13 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 59779-334 | 59779-334-17 | D | Discontinued by firm | 2026-10-15 |
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 | 59779-334-13 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-334-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-334-07 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-334-06 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-334-07 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-334-13 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-334-06 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-334-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-334-13 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-334-06 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-334-12 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-334-07 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-334-13 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-334-06 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-334-12 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-334-07 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-334-13 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-334-06 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-334-12 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-334-07 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-334-13 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-334-06 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-334-12 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-334-07 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-334-13 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-334-06 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-334-12 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-334-07 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-334-13 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-334-06 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-334-12 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-334-07 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-334-13 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-334-06 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-334-12 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-334-07 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-334-13 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-334-06 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-334-12 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-334-07 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59779-334-13 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59779-334-06 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59779-334-12 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59779-334-07 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59779-334-13 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59779-334-07 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59779-334-12 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59779-334-06 | 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
- Listing expiration
- 2027-12-31
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 |
|---|---|
| 31ccc867-ca83-70a9-f3d5-5644030047b8 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59779-334-06 | Headache ReliefExtra Strength | 200 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 200 | 41 | |
| 59779-334-07 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 41 | |
| 59779-334-07 | Headache ReliefExtra Strength | 36 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 36 | 41 | |
| 59779-334-08 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 41 | |
| 59779-334-08 | Headache ReliefExtra Strength | 24 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 24 | 41 | |
| 59779-334-12 | Headache ReliefExtra Strength | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | 41 | |
| 59779-334-12 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 41 | |
| 59779-334-13 | Headache ReliefExtra Strength | 250 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 250 | 41 | |
| 59779-334-13 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 41 | |
| 59779-334-17 | Headache ReliefExtra Strength | 300 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 300 | 41 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59779-334-08 | EA - Each | 59779-334 | 6a20aafb-5f39-44e9-8a9f-4af58e60b112 | 1 | 2018-02-20 |
| 59779-334-12 | EA - Each | 59779-334 | d7dee814-e2c4-42ac-ba37-e56a728042bb | 1 | 2017-06-15 |
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 |
|---|---|---|---|---|---|---|
| EXTRA STRENGTH PAIN RELIEVER | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Geri-Care Pharmaceutical Corp | b670a898-2360-76e2-e053-2a95a90a3380 | 2025-11-17 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | ec902e52-0f48-4a61-b67d-17e1c1461619 | 2025-11-15 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | L.N.K. International, Inc. | 72babe91-2586-4f05-ae90-6debfd23aa5d | 2025-11-15 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Strategic Sourcing Services LLC | 3c7883da-6f51-4716-b012-0e33d239a60e | 2025-11-15 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Sam's West Inc | 3b84746f-05ab-4f88-b9ae-efb8c5dfc233 | 2025-11-15 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Walgreen Company | a482e715-bec0-44a4-bb0e-ea5f5fda558e | 2025-11-15 | Warnings | M013 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | f1157dbc-d86c-4554-954c-60a74674ff6b | 2025-11-15 | Warnings | M013 |
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | NuCare Pharmaceuticals,Inc. | 437e4fd9-c7d9-77d6-e063-6294a90a22b7 | 2025-11-13 | Warnings | M013 |
| Good Sense Pain Relief | ACETAMINOPHEN | L. Perrigo Company | 7f78028a-484b-48b3-a37a-1e0b055bbefc | 2025-11-13 | Warnings | M013 |
| OneSsip Acetaminophen | ACETAMINOPHEN | MEDWISE LIFESCIENCES INC. | 3f88de0f-6cf6-3580-e063-6294a90abcb4 | 2025-11-12 | Warnings | M013 |
| Tylenol PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b1a31-353d-af20-e063-6294a90aa907 | 2025-11-11 | Warnings | M013 |
| Good Neighbor Pharmacy Pain Relief | ACETAMINOPHEN | Amerisource Bergen | 4b829607-f5fb-427f-83b5-5b6b9c44ebeb | 2025-11-11 | Warnings | M013 |
| Pamprin Max Menstrual Pain Relief | ACETAMINOPHEN AND ASPIRIN AND CAFFEINE | Focus Consumer Healthcare, LLC | 5bd4b935-f003-7df8-e053-2a91aa0a5d79 | 2025-11-10 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Shield Pharmaceuticals Corp | 61e50135-a7c2-4a86-8a1a-d47b41d3f9d1 | 2025-11-07 | Warnings | M013 |
| Childrens Chewables | ACETAMINOPHEN | Strategic Sourcing Services LLC | af2cbbaf-9b73-440a-bc88-a790cafccc6b | 2025-11-07 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | L.N.K. International, Inc. | 39e142a7-8590-4e1e-8319-6904fb57cc8a | 2025-11-06 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 42321456-d7dd-3b51-e063-6394a90ac292 | 2025-11-05 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | Family Dollar Services Inc | 76058eb3-2d3f-4414-87df-7167cd27d26b | 2025-11-05 | Warnings | M013 |
| Children Pain and Fever Reliver | ACETAMINOPHEN | Target Corporation | 1116f808-f61e-47ec-b0d0-d4be5aa905be | 2025-11-04 | Warnings | M013 |
| Pain Reliever Dye Free | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | 42c4f0b2-6483-0f3c-e063-6294a90a140f | 2025-11-04 | 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 | 31ccc867-ca83-70a9-f3d5-5644030047b8 | 41 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 31ccc867-ca83-70a9-f3d5-5644030047b8 | 41 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 31ccc867-ca83-70a9-f3d5-5644030047b8 | 41 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59779-334-06 | 59779033406 | 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59779-334-06) | 2008-03-13 | 0000-00-00 | No | No | Current |
| 59779-334-07 | 59779033407 | 1 BOTTLE, PLASTIC in 1 CARTON (59779-334-07) > 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2008-03-13 | 0000-00-00 | No | No | Current |
| 59779-334-08 | 59779033408 | 1 BOTTLE, PLASTIC in 1 CARTON (59779-334-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2008-03-13 | 0000-00-00 | No | No | Current |
| 59779-334-12 | 59779033412 | 1 BOTTLE, PLASTIC in 1 CARTON (59779-334-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2008-03-13 | 0000-00-00 | No | No | Current |
| 59779-334-13 | 59779033413 | 250 in 1 BOTTLE, PLASTIC | Historical | ||||
| 59779-334-17 | 59779033417 | 300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59779-334-17) | 2008-03-13 | 0000-00-00 | No | No | Current |