Home NDC 67091-112 Headache Relief
Product NDC 67091-112
11-digit product format 670910112
Labeler code 67091
Product ID 67091-112_6309a579-a1a7-41fb-ab83-e8c561c5cb1f
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Aspirin, Caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler WinCo Foods, LLC
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 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 table Ingredient Strength ACETAMINOPHEN 250 mg/1 ASPIRIN 250 mg/1 CAFFEINE 65 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67091-112-10 Headache ReliefExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 15 67091-112-10 Headache ReliefExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 ASPIRIN ACTIVE INGREDIENT R16CO5Y76E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 ASPIRIN ACTIVE MOIETY R16CO5Y76E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 CAFFEINE ACTIVE MOIETY 3G6A5W338E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [WINCO FOODS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-112 HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [WINCO FOODS, LLC] 14 Current NDC, Legacy NDC, 2 package rows 20240906_fbd2a03f-c9cd-4b0d-b9b1-aaa3bc14efb4.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.
Matched openFDA labels page 1 of 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67091-112-10 67091011210 1 BOTTLE, PLASTIC in 1 CARTON (67091-112-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2008-03-13 0000-00-00 No No Current