Home NDC 63868-485 Headache Relief
Product NDC 63868-485
11-digit product format 638680485
Labeler code 63868
Product ID 63868-485_db6c7572-59e0-4734-bfd6-1117dad5dd1b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Aspirin and caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CHAIN DRUG MARKETING ASSOCIATION INC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 1992-11-17
Marketing end 2027-03-31
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 63868-485-01 Headache ReliefExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 30 63868-485-01 Headache ReliefExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 30 63868-485-02 Headache ReliefExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 30 63868-485-02 Headache ReliefExtra Strength 200 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 200 30 63868-485-24 Headache ReliefExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 30 63868-485-24 Headache ReliefExtra Strength 24 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 24 30 63868-485-50 Headache ReliefExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 50 30 63868-485-50 Headache ReliefExtra Strength 1 in 1 CARTON TABLET, FILM COATED 1 30
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 [CHAIN DRUG MARKETING ASSOCIATION INC] 13 ASPIRIN ACTIVE INGREDIENT R16CO5Y76E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 ASPIRIN ACTIVE MOIETY R16CO5Y76E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 CAFFEINE ACTIVE MOIETY 3G6A5W338E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 POVIDONES INACTIVE INGREDIENT FZ989GH94E HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-485 HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 29 Current NDC, Legacy NDC, 8 package rows 20240709_4005f8dd-3050-4590-8703-6997444e8df3.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 64 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tylenol PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Jones Healthcare Group - Packaging Services, Inc 639f4e01-9723-a619-e053-2991aa0a549a 2024-08-27 Warnings Exact identifier application number: M013 Extra Strength Acetaminohpen Adult Rapid Burst Cherry ACETAMINOPHEN Major Pharmaceuticals 9e7543d9-6249-45b5-b67d-c1b439423b9c 2024-08-27 Warnings Exact identifier application number: M013 aspirin ASPIRIN Major Pharmaceuticals 58684138-04d1-44a4-bc52-c5b85d93d7a6 2024-08-23 Warnings Exact identifier application number: M013 Up and Up childrens acetaminophen ACETAMINOPHEN Target Corporation 9c3ba4dd-f51b-46ce-91b8-8b617c7b78da 2024-08-23 Warnings Exact identifier application number: M013 CVS Effervescent Pain Reliever ASPIRIN CVS PHARMACY 0761147f-1337-606e-e063-6394a90abd5d 2024-08-22 Warnings Exact identifier application number: M013 pain reliever ACETAMINOPHEN Walgreen Company 8255900a-2d58-4261-8df7-f28319883570 2024-08-21 Warnings Exact identifier application number: M013 Pain and Fever ACETAMINOPHEN H E B 86a072a9-c3b8-47f7-8598-d66e3d30e762 2024-08-21 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Kroger Company d965eba0-b268-41b2-8e02-5f6d769a44d7 2024-08-18 Warnings Exact identifier application number: M013 equate pain and fever childrens ACETAMINOPHEN Wal-Mart Stores Inc ea68d735-c677-4280-a3a3-ae3eb5ff7462 2024-08-17 Warnings Exact identifier application number: M013 childrens pain and fever ACETAMINOPHEN CVS Pharmacy fac408f0-ebb6-4c72-88ee-2ba85867859c 2024-08-16 Warnings Exact identifier application number: M013 Regular Strength Pain Relief ACETAMINOPHEN Bryant Ranch Prepack 3f0c32b1-2c54-4ca3-9759-9e5dd9d7ad24 2024-08-14 Warnings Exact identifier application number: M013 Quality Choice Effervescent Antacid and Pain Relief - Extra Strength ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 1f926637-a61c-8eb7-e063-6394a90a6502 2024-08-13 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PAI Holdings, LLC dba PAI Pharma 6ec12573-03d6-40c1-9945-d345b401e062 2024-08-12 Warnings Exact identifier application number: M013 CareOne Infants Acetaminophen ACETAMINOPHEN American Sales Company eacee273-abd7-4ea4-bcaa-7f74abcc9feb 2024-08-07 Warnings Exact identifier application number: M013 infants pain and fever ACETAMINOPHEN Kroger Company 7dbe284a-c0d5-4ac4-8445-611610f3c0fb 2024-08-02 Warnings Exact identifier application number: M013 Dollar General Effervescent Pain Reliever ASPIRIN Dolgencorp, Inc 1deab362-a325-3a00-e063-6294a90a9acd 2024-08-01 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN FSA STORE INC. 1cd6a3e6-1376-0b7b-e063-6394a90af3d1 2024-07-30 Warnings Exact identifier application number: M013 pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Publix Super Markets Inc 42d271b7-b45f-4497-8de2-4e05b4bebfa9 2024-07-17 Warnings Exact identifier application number: M013 basic care acetaminophen pm ACETAMINOPHEN, DIPHENHYDRAMINE HCL Amazon.com Services LLC 64a0084a-e29e-4c1a-8704-13a3e1238f76 2024-07-17 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN Walmart Inc. 152c013a-c81c-f8f9-e063-6294a90a9f23 2024-07-15 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 63868-485-01 63868048501 1 BOTTLE, PLASTIC in 1 CARTON (63868-485-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1992-11-17 2027-03-31 No No Current 63868-485-02 63868048502 1 in 1 CARTON Historical 63868-485-24 63868048524 1 BOTTLE, PLASTIC in 1 CARTON (63868-485-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1992-11-17 2027-03-31 No No Current 63868-485-50 63868048550 1 BOTTLE, PLASTIC in 1 CARTON (63868-485-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 1992-11-17 2027-03-31 No No Current