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 72 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Excedrin Tension Headache ACETAMINOPHEN, CAFFEINE Haleon US Holdings LLC 12c074d1-81ac-47d2-8747-b018cda0058a 2024-03-13 Warnings Exact identifier application number: M013 Menstrual Complete ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE Strive Pharmaceuticals Inc. 78c12459-3b27-4ed0-943d-520794eb438d 2024-03-07 Warnings Exact identifier application number: M013 Pain Reliever fever Reducer Extra Strength ACETAMINOPHEN CVS Pharmacy 7b5263ad-01b7-4fc5-9384-4da8efe89e35 2024-03-06 Warnings Exact identifier application number: M013 Excedrin Extra Strength Geltabs ACETAMINOPHEN, ASPRIN, CAFFEINE Haleon US Holdings LLC 11a8439b-0159-4351-b0f5-fe7fad6a33c0 2024-03-05 Warnings Exact identifier application number: M013 Winco Foods Effervescent Pain Relief ASPIRIN Winco Foods, LLC 128afdd7-a9d1-8957-e063-6294a90af569 2024-03-05 Warnings Exact identifier application number: M013 Aspirin Low Dose Safety Coated ASPIRIN Care One (Retail Business Services, LLC.) 6659e103-fa03-4de0-af42-d2fbd548a87c 2024-03-05 Warnings Exact identifier application number: M013 Dolex Children Pain and Fever ACETAMINOPHEN Pharmadel LLC f9158463-aeb1-5de0-e053-6294a90a748b 2024-03-04 Warnings Exact identifier application number: M013 SEDALMEX FORTE ACETAMINOPHEN, ASPIRIN, CAFFEINE Belmora LLC 33b3508e-4caa-4d05-9b15-cb82a2ee2d4d 2024-02-28 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN AMERISOURCE BERGEN 2b923a97-836c-4dac-a8c0-3047a35fb62e 2024-02-23 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL BJWC (Berkley & Jensen / BJ's) b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86 2024-02-22 Warnings Exact identifier application number: M013 M-PAP ACETAMINOPHEN Bryant Ranch Prepack 31a41976-7f65-42d7-acf5-de9c2c5ca58e 2024-02-20 Warnings Exact identifier application number: M013 Publix Fast Relief Effervescent - Original Flavor ASPIRIN PUBLIX SUPER MARKETS INC. 0a342f72-45fd-3e12-e063-6394a90ae33e 2024-02-16 Warnings Exact identifier application number: M013 Equaline Effervescent Pain Reliever ASPIRIN UNITED NATURAL FOODS, INC. DBA UNFI 0761299a-e913-7665-e063-6394a90a6003 2024-02-16 Warnings Exact identifier application number: M013 TopCare Effervescent Pain Relief ASPIRIN TOPCO ASSOCIATES LLC 075f36e1-110c-e839-e063-6294a90a89d7 2024-02-16 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever ACETAMINOPHEN INGLES MARKETS, INC. 115d0b4f-6f0f-79a9-e063-6394a90ab18a 2024-02-14 Warnings Exact identifier application number: M013 PANADOL ACETAMINOPHEN Haleon US Holdings LLC e1799765-c247-42b4-ad6a-8ba7d136abf2 2024-02-06 Warnings Exact identifier application number: M013 Panadol Cold and Flu NonDrowsy ACETAMINOPHEN AND PHENYLEPRINE HCL Haleon US Holdings LLC f626ab17-01c9-4493-ba9e-0c8c11146384 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra ACETAMINOPHEN AND CAFFEINE Haleon US Holdings LLC e5c2d88a-d903-4ca0-b895-f27e791dfc4e 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra Strength ACETAMINOPHEN Haleon US Holdings LLC b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra Strength ACETAMINOPHEN Haleon US Holdings LLC 9d384e88-5c11-4600-ac6c-a38371570138 2024-02-06 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