Home NDC 41226-370-01 HEADACHE RELIEF
Product NDC 41226-370
Requested package NDC 41226-370-01
11-digit product format 412260370
Labeler code 41226
Product ID 41226-370_3992e879-0f22-1e3f-e063-6294a90a67f8
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Dosage form TABLET, COATED
Route ORAL
Labeler Kroger Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-10
Substance CAFFEINE; ASPIRIN; ACETAMINOPHEN
Active strength 65; 250; 250 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 41226-370 41226-370-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 41226-370 41226-370-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 41226-370 41226-370-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAFFEINE 65 mg/1 ASPIRIN 250 mg/1 ACETAMINOPHEN 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3G6A5W338E Internal UNII lookup R16CO5Y76E Internal UNII lookup 362O9ITL9D 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41226-370-01 HEADACHE RELIEF 100 in 1 BOTTLE TABLET, COATED 100 4 41226-370-01 HEADACHE RELIEF 1 in 1 CARTON TABLET, COATED 1 4 41226-370-42 HEADACHE RELIEF 1 in 1 CARTON TABLET, COATED 1 4 41226-370-42 HEADACHE RELIEF 24 in 1 BOTTLE TABLET, COATED 24 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41226-370 HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, COATED [KROGER COMPANY] 3 Current NDC, Legacy NDC, 4 package rows 20250216_bbed29a1-3c52-3531-e053-2995a90a686c.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 118 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join daytime severe cold multi-symptom ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL United Natural Foods, Inc. dba UNFI cc7c5f1c-76b7-4278-8e2a-5fbc85e022dd 2025-03-08 Warnings Exact identifier application number: M012 Cold and Head Congestion Relief Severe ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL WinCo Foods, LLC a39778ba-1f63-4495-8e9b-44b0bdd7f71a 2025-03-08 Warnings Exact identifier application number: M012 Extra Strength TYLENOL Severe Cough Plus Sore Throat Day ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE Kenvue Brands LLC 2e9540e4-bd1d-9370-e063-6294a90affcb 2025-03-07 Warnings Exact identifier application number: M012 Herbal Cough Drops Original Herb COUGH DROPS Topco Associates LLC 2fb22181-aee3-d0bf-e063-6294a90a7865 2025-03-06 Warnings Exact identifier application number: M012 REVASOL DAYTIME COLD AND FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE Rnv LLC 2f9ddcc3-b913-f8b0-e063-6294a90a93ab 2025-03-05 Warnings Exact identifier application number: M012 Herbal Throat Drops Lemon Mint Herb THROAT DROPS Topco Associates LLC 2fa086b4-3b0e-0df8-e063-6294a90a6769 2025-03-05 Warnings Exact identifier application number: M012 Redicare Nasal and Sinus Decongestant REDICARE NASAL AND SINUS DECONGESTANT Redicare LLC 2f24be68-f30e-d916-e063-6294a90a7e31 2025-03-04 Warnings Exact identifier application number: M012 Diphenhydramine HCl Oral Solution DIPHENHYDRAMINE HCL ORAL SOLUTION Kesin Pharma Corporation 2f871005-de4d-8b2a-e063-6394a90aa43a 2025-03-04 Warnings Exact identifier application number: M012 CVS Daytime Cough Relief Chews - Citrus Punch DEXTROMETHORPHAN HBR CVS 2f885f1b-7ff5-251b-e063-6394a90a656f 2025-03-04 Warnings Exact identifier application number: M012 CVS Dex-Dox Kids Nighttime Cough Suppressant DEXTROMETHORPHAN HBR CVS 2f8b6f5e-399c-b033-e063-6294a90ac3d1 2025-03-04 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ff8b096c-8f01-4a8c-a98f-e4aa4d688e95 2025-03-04 Warnings Exact identifier application number: M012 Menthol Cough Drops Honey Vanilla Flavor MENTHOL 7-ELEVEN 2f3c43dd-175f-722e-e063-6294a90acff9 2025-02-28 Warnings Exact identifier application number: M012 Menthol Cough Drops Creamy Strawberry Flavor MENTHOL AND PECTIN 7-ELEVEN 2f3c3c65-4178-6304-e063-6294a90a51fa 2025-02-28 Warnings Exact identifier application number: M012 Menthol Cough Drops Creamy Strawberry Flavor MENTHOL AND PECTIN Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 2efbffd7-bbdd-c5f5-e063-6294a90a15f0 2025-02-25 Warnings Exact identifier application number: M012 Menthol Cough Drops Honey Vanilla Flavor MENTHOL Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 2efc46c9-a421-1998-e063-6394a90aeb64 2025-02-25 Warnings Exact identifier application number: M012 Redicare Cough Drops Cherry Flavored CHERRY FLAVORED MENTHOL COUGH DROPS Redicare LLC 2efeaafa-ee96-37ee-e063-6394a90a9a4b 2025-02-25 Warnings Exact identifier application number: M012 Childrens Allergy DIPHENHYDRAMINE HCL Genexa Inc. e880b8d7-61c3-41cc-e053-2995a90aaaeb 2025-02-20 Warnings Exact identifier application number: M012 Gencare-Nasal Decongestant PE PHENYLEPHRINE HYDROCHLORIDE Pioneer Life Sciences, LLC 596ec923-56a0-4b6e-a69c-8d740feb75a2 2025-02-20 Warnings Exact identifier application number: M012 Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Kenvue Brands LLC 77a2dc96-73ee-4ca2-b1fe-406995802606 2025-02-19 Warnings Exact identifier application number: M012 nasal decongestant OXYMETAZOLINE HYDROCHLORIDE Safeway f1d0edd5-fe58-4de0-98f4-07fb24bd0ac2 2025-02-19 Warnings Exact identifier application number: M012
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 41226-370-01 41226037001 1 BOTTLE in 1 CARTON (41226-370-01) / 100 TABLET, COATED in 1 BOTTLE 1 bottle 2021-04-10 0000-00-00 No No Current