FDA.reportPublic FDA data

Headache Relief

Product NDC
57243-159
11-digit product format
572430159
Labeler code
57243
Product ID
57243-159_1b88c7e2-d114-490f-b2fb-ff05f10344ca
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin and caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Salado Sales, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-11-17
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

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
IngredientStrength
ACETAMINOPHEN250 mg/1
ASPIRIN250 mg/1
CAFFEINE65 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, R16CO5Y76E, 3G6A5W338E
Rxcui308297

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57243-159-08Headache ReliefExtra Strength1 in 1 CARTONTABLET, FILM COATED117
57243-159-08Headache ReliefExtra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2417

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
ASPIRINACTIVE INGREDIENTR16CO5Y76EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
ASPIRINACTIVE MOIETYR16CO5Y76EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
CAFFEINEACTIVE MOIETY3G6A5W338EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57243-159HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.]16Current NDC, Legacy NDC, 2 package rows20250512_ca21d576-be3c-495d-9dbd-ed514bf65da7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNca21d576-be3c-495d-9dbd-ed514bf65da717
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDca21d576-be3c-495d-9dbd-ed514bf65da717
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYca21d576-be3c-495d-9dbd-ed514bf65da717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57243-159-08572430159081 BOTTLE, PLASTIC in 1 CARTON (57243-159-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1992-11-170000-00-00NoNoCurrent