Home NDC 57243-159-08 Headache Relief
Product NDC 57243-159
Requested package NDC 57243-159-08
11-digit product format 572430159
Labeler code 57243
Product ID 57243-159_dcd94530-ff87-4cc8-ab8d-a04c7aece039
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
Marketing end 2026-11-30
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
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 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 ASPIRIN 250 mg/1 CAFFEINE 65 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup R16CO5Y76E Internal UNII lookup 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308297 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57243-159-08 Headache ReliefExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 17 57243-159-08 Headache ReliefExtra Strength 24 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 24 17
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 AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 ASPIRIN ACTIVE INGREDIENT R16CO5Y76E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 ASPIRIN ACTIVE MOIETY R16CO5Y76E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 CAFFEINE ACTIVE MOIETY 3G6A5W338E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57243-159 HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [SALADO SALES, INC.] 16 Current NDC, Legacy NDC, 2 package rows 20250512_ca21d576-be3c-495d-9dbd-ed514bf65da7.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 22 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TYLENOL Regular Strength ACETAMINOPHEN Kenvue Brands LLC 01f41fae-4abb-4b96-ab09-a7d3dfc286cd 2026-01-26 Warnings Exact identifier application number: M013 pain relief ACETAMINOPHEN Meijer Distribution Inc ec4dbb71-b507-42a3-9b68-14d4b6621ec1 2026-01-23 Warnings Exact identifier application number: M013 Adult Low Dose Aspirin ASPIRIN NCS HealthCare of KY, LLC dba Vangard Labs 9105eff0-1c22-4298-8ee5-9fb7a1de12f1 2026-01-23 Warnings Exact identifier application number: M013 Extra Strength Pain Relief ACETAMINOPHEN Preferred Pharmaceuticals Inc. c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e 2026-01-22 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 17cfa99d-abb2-4d77-9e0e-e77109fbb61a 2026-01-21 Warnings Exact identifier application number: M013 Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg ACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MG Farmacias De Similares TX LLC 48ea0a2c-511b-4805-e063-6394a90a1225 2026-01-21 Warnings Exact identifier application number: M013 childrens mapap ACETAMINOPHEN Major Pharmaceuticals a1b0ccf0-cf24-4b34-b42a-aa1cc1e57f60 2026-01-20 Warnings Exact identifier application number: M013 EXTRA STRENGTH ACETAMINOPHEN ACETAMINOPHEN WALGREENS CO. 9b756e4e-6c56-43aa-a5bc-5b649440e759 2026-01-20 Warnings Exact identifier application number: M013 EXTRA STRENGTH PAIN RELIEVER PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WALGREENS CO. 5a58d620-a0ec-48d7-92dd-3f3f78ec10ea 2026-01-20 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN Wal-Mart Stores Inc d4e438c6-80dd-4531-91e6-bc4ca7a8570f 2026-01-20 Warnings Exact identifier application number: M013 Unishield Extra Strength Non-Aspirin ACETAMINOPHEN Unishield ba0ec1eb-db85-6a7f-e053-2995a90aafe5 2026-01-19 Warnings Exact identifier application number: M013 pain relief ACETAMINOPHEN HyVee Inc 24acd62f-72b1-418a-b733-7e4888f3c0a3 2026-01-16 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Cardinal Health 110, LLC. DBA Leader dd8b13a5-07df-4cec-92c3-1a662b1e1a56 2026-01-16 Warnings Exact identifier application number: M013 EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 7d8f8389-730d-494e-a0af-5a91a3c99e17 2026-01-16 Warnings Exact identifier application number: M013 TENSION HEADACHE RELIEF ACETAMINOPHEN AND CAFFEINE WALGREENS 54aff6a0-2778-472f-90ba-375d6bce6ee8 2026-01-16 Warnings Exact identifier application number: M013 EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 097fbab7-3886-4e75-b037-f03adcf3859f 2026-01-16 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREENS CO. bdb09e15-8e17-4987-99d0-bab8856a2109 2026-01-16 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN HF Acquisition Co LLC, DBA HealthFirst 4870ff00-f727-814d-e063-6394a90a6c8e 2026-01-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN HyVee Inc 957b13a4-4086-459f-8fa0-9708b317fabe 2026-01-15 Warnings Exact identifier application number: M013 Unisom PM Pain Nighttime Sleep Aid and Pain Reliever ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Chattem, Inc. 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb 2026-01-14 Warnings Exact identifier application number: M013
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 57243-159-08 57243015908 1 BOTTLE, PLASTIC in 1 CARTON (57243-159-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1992-11-17 2026-11-30 No No Current