Headache Relief
- Product NDC
- 69168-285
- 11-digit product format
- 691680285
- Labeler code
- 69168
- Product ID
- 69168-285_62d55418-7d3d-4708-af3a-2969be915e4a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Aspirin and Caffeine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Allegiant Health
- Application
- NDA020802
- Marketing category
- NDA
- Marketing start
- 2010-02-15
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Headache Relief
- Brand name suffix
- Extra Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 250 mg/1 |
| ASPIRIN | 250 mg/1 |
| CAFFEINE | 65 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, R16CO5Y76E, 3G6A5W338E |
| Rxcui | 308297 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69168-285-24 | Headache ReliefExtra Strength | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | | 4 |
| 69168-285-24 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 4 |
| 69168-285-37 | Headache ReliefExtra Strength | 16 in 1 BOTTLE | TABLET, FILM COATED | 16 | | 4 |
| 69168-285-37 | Headache ReliefExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69168-285 | HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [ALLEGIANT HEALTH] | 4 | Current NDC, Legacy NDC, 4 package rows | 20220910_6197eff5-0351-42ef-bb3f-cbc26e6d0d14.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69168-285-24 | 69168028524 | 1 BOTTLE in 1 CARTON (69168-285-24) > 24 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2010-02-15 | 2024-03-31 | No | No | Current |
| 69168-285-37 | 69168028537 | 1 BOTTLE in 1 CARTON (69168-285-37) / 16 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2022-09-08 | 0000-00-00 | No | No | Current |