Headache Relief
- Product NDC
- 49035-433
- 11-digit product format
- 490350433
- Labeler code
- 49035
- Product ID
- 49035-433_a5077198-1083-408b-9727-b89909de0558
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin and Caffeine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wal-Mart Stores Inc
- 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 | 49035-433 | 49035-433-06 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 49035-433 | 49035-433-85 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|
| 9b1201af-c802-4e19-b192-bbbf34367db4 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-433-06 | Headache ReliefExtra Strength | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 17 | |
| 49035-433-08 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 17 | |
| 49035-433-08 | Headache ReliefExtra Strength | 24 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 24 | 17 | |
| 49035-433-12 | Headache ReliefExtra Strength | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | 17 | |
| 49035-433-85 | Headache ReliefExtra Strength | 200 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 200 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49035-433-06 | EA - Each | 49035-433 | 733cc245-97e9-47ca-84a4-cd7448ce0734 | 1 | 2024-04-05 |
| 49035-433-08 | EA - Each | 49035-433 | 110860f9-5ace-49e2-b01c-da9c7062a828 | 1 | 2019-08-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49035-433 | HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [WAL-MART STORES INC] | 16 | Current NDC, Legacy NDC, 5 package rows | 20250501_9b1201af-c802-4e19-b192-bbbf34367db4.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 |
|---|---|---|---|---|---|---|
| Childrens Pain Relief Dye free | ACTEMINOPHEN | BETTER LIVING BRANDS LLC. | 41f504d1-29c4-f075-e063-6394a90ad64c | 2026-04-11 | Warnings | M013 |
| Dr. Simi Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Farmacias De Similares TX LLC | 4f1e1f1a-44f4-2356-e063-6294a90a8cdd | 2026-04-10 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | Akron Pharma Inc. | e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed | 2026-04-10 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | Akron Pharma Inc. | 28413cb3-22c4-40e2-ad6b-42beb438dea3 | 2026-04-10 | Warnings | M013 |
| Pain Reliever Childrens | ACETAMINOPHEN | H E B | 7e43de11-d20b-4920-a04d-3c1b5d35e005 | 2026-04-09 | Warnings | M013 |
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Navajo Manufacturing Company Inc. | f7e572e9-82a7-2127-e053-6394a90ab01a | 2026-04-08 | Warnings | M013 |
| Bayer Genuine Aspirin | ASPIRIN | Navajo Manufacturing Company Inc. | f6f2ce71-5728-aefb-e053-6394a90a20e4 | 2026-04-08 | Warnings | M013 |
| Midol | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | Navajo Manufacturing Company Inc. | cabd10f2-a91e-4406-9249-915e306c867b | 2026-04-08 | Warnings | M013 |
| Aspirin | ASPIRIN | HyVee Inc | 3730ee46-b241-44eb-94fa-52b9d12a9c35 | 2026-04-08 | Warnings | M013 |
| Aspirin | ASPIRIN | Walgreen Company | 82cc404b-fcf5-4e48-ab1a-09d8c47f9e04 | 2026-04-08 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | 9efcce86-dd57-4ea2-ad31-d2038eb61bf1 | 2026-04-07 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 1b164780-ec84-4187-8afa-6f8a0da550fc | 2026-04-07 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 201b860d-dc3c-4380-affa-e757bf2103cf | 2026-04-07 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Walgreens | 6e7475e2-81a9-43b5-9b81-b58ab761a6f4 | 2026-04-07 | Warnings | M013 |
| Pain Relief Aspirin Low Dose | ASPIRIN | Rite Aid Corporation | 503408ed-e799-48a0-8d38-3034f4a0ead5 | 2026-04-02 | Warnings | M013 |
| Aspirin 81 mg | ASPIRIN | Lidl US LLC | 468f4a2f-60f7-4808-95d7-a00be1bb112f | 2026-04-02 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | Grocery Outlet, Inc. | 44de6f5a-0b5c-6c28-e063-6394a90a7e0b | 2026-04-02 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | ARMY AND AIR FORCE EXCHANGE SERVICE | 26ae0d0a-34c0-4d16-951a-8d5a463c808b | 2026-04-02 | Warnings | M013 |
| Pain Reliever plus Sleep Aid NightTime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Kroger Company | 286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d0 | 2026-04-02 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | COSTCO WHOLESALE CORPORATION | c8a8986b-1ab4-9da0-71da-42595db08b44 | 2026-04-02 | 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 | 9b1201af-c802-4e19-b192-bbbf34367db4 | 17 |
| 308297 | acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet | SCD | 9b1201af-c802-4e19-b192-bbbf34367db4 | 17 |
| 308297 | APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet | SY | 9b1201af-c802-4e19-b192-bbbf34367db4 | 17 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49035-433-06 | 49035043306 | 2 BOTTLE in 1 CARTON (49035-433-06) > 100 TABLET, FILM COATED in 1 BOTTLE (49035-433-12) | 2 bottle | 2008-03-13 | 0000-00-00 | No | No | Current |
| 49035-433-08 | 49035043308 | 1 BOTTLE, PLASTIC in 1 CARTON (49035-433-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2008-03-13 | 0000-00-00 | No | No | Current | |
| 49035-433-12 | 49035043312 | 100 in 1 BOTTLE, PLASTIC | Historical | |||||
| 49035-433-85 | 49035043385 | 200 TABLET, FILM COATED in 1 BOTTLE (49035-433-85) | 2008-03-13 | 0000-00-00 | No | No | Current |