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 54 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NOTTS - Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE VIVUNT PHARMA LLC e6754f62-e3b2-773f-e053-2a95a90ad36a 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN AAA Pharmaceutical, Inc. a891896d-c9fa-4448-915a-e6b531157d22 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN SAFEWAY d2d15e06-e9eb-3d2b-e053-2995a90a1cec 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Regular Strength ACETAMINOPHEN TopCo Associates LLC c2d33352-431c-4683-a4fa-a54437e7b8d2 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN TopCo Associates LLC bdb01b3e-ad34-4003-9b9a-e83a2c0e90bb 2024-12-02 Warnings Exact identifier application number: M013 Aspirin 81mg Adult Low Dose ASPIRIN TopCare 14d010fb-c4a1-4c3d-942f-58719727bfc0 2024-12-02 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS Pharmacy, Inc c4473ee6-4e01-1ec2-e053-2995a90ac513 2024-12-02 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Proficient Rx LP 9c186289-e309-45e8-8934-1d0eae0375c2 2024-12-01 Warnings Exact identifier application number: M013 Childrens Chewable Acetaminophen ACETAMINOPHEN GERI-CARE PHARMACEUTICAL CORP 22f63d62-c941-5b8f-e063-6394a90aeecd 2024-11-28 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Geri-Care Pharmaceutical Corp 7a7b6318-b7d6-31b1-e053-2991aa0abf25 2024-11-28 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL INGLES MARKETS, INC. 27fd288e-c07a-617f-e063-6394a90a17a4 2024-11-28 Warnings Exact identifier application number: M013 BAYER Aspirin Original, TRAVEL BASIX ASPIRIN Lil' Drug Store Products, Inc. 7f5d9ebe-8119-49a2-9380-eca18a5e5e85 2024-11-27 Warnings Exact identifier application number: M013 EXCEDRIN MIGRAINE ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE Jones Healthcare Group - Packaging Services, Inc c4168e4d-3dfc-4e51-a32e-14704cb59c66 2024-11-27 Warnings Exact identifier application number: M013 TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief ACETAMINOPHEN, LIDOCAINE, MENTHOL Kenvue Brands LLC 2611e984-0dd5-bda1-e063-6394a90a559a 2024-11-26 Warnings Exact identifier application number: M013 First Aid Only Extra-Strength Non-Aspirin ACETAMINOPHEN Acme United Corporation 6891d57a-10a6-53de-e053-2a91aa0ac7c2 2024-11-26 Warnings Exact identifier application number: M013 Chewable Aspirin ASPIRIN MARC GLASSMAN, INC. c8314910-71ff-5a55-e053-2995a90aafc7 2024-11-26 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Marc Glassman, Inc. 7990ca49-fb30-40fe-9ac4-48e89eac9bb2 2024-11-26 Warnings Exact identifier application number: M013 Enteric Coated Aspirin Regular Strength ASPIRIN Safeway 96359eb6-62bc-4b13-960c-050af99a8c02 2024-11-26 Warnings Exact identifier application number: M013 ASPIRIN Low Dose ASPIRIN Marc Glassman, Inc. 3d519af3-9398-4439-8253-1e5d4612b8e3 2024-11-26 Warnings Exact identifier application number: M013 ACETAMINOPHEN (RED) ACETAMINOPHEN Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 06eabf4b-f8c0-439a-acf1-aa6e3075c717 2024-11-25 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