FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63868-48563868-485-02DDiscontinued by firm2026-10-21

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
IngredientStrength
ACETAMINOPHEN250 mg/1
ASPIRIN250 mg/1
CAFFEINE65 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
R16CO5Y76EInternal UNII lookup
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308297Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4005f8dd-3050-4590-8703-6997444e8df3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
377068df-225f-7318-a910-a1987cdfa361Product name320170608
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-485-01Headache ReliefExtra Strength1 in 1 CARTONTABLET, FILM COATED130
63868-485-01Headache ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10030
63868-485-02Headache ReliefExtra Strength1 in 1 CARTONTABLET, FILM COATED130
63868-485-02Headache ReliefExtra Strength200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20030
63868-485-24Headache ReliefExtra Strength1 in 1 CARTONTABLET, FILM COATED130
63868-485-24Headache ReliefExtra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2430
63868-485-50Headache ReliefExtra Strength50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5030
63868-485-50Headache ReliefExtra Strength1 in 1 CARTONTABLET, FILM COATED130

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-485-01EA - Each63868-485716fc68f-d537-4ab9-8fdc-fc1442f50b5312012-07-24
63868-485-24EA - Each63868-4853589439d-c046-42eb-980e-c5f94fe79d3812022-10-06
63868-485-50EA - Each63868-485e70cc807-5ef7-44c7-8d3a-896a96bbc07d12022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
ASPIRINACTIVE INGREDIENTR16CO5Y76EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
CAFFEINEACTIVE INGREDIENT3G6A5W338EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
ASPIRINACTIVE MOIETYR16CO5Y76EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
CAFFEINEACTIVE MOIETY3G6A5W338EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
POVIDONESINACTIVE INGREDIENTFZ989GH94EHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEADACHE 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
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-485HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]29Current NDC, Legacy NDC, 8 package rows20240709_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 58 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenPAIN RELIEVERMcKesson9d620700-5d00-475f-e053-2995a90a9a3f2024-10-28WarningsExact identifier
application number: M013
Junior Acetaminophen Ages 6-11ACETAMINOPHENChain Drug Consortiumd356bc9c-66f1-45c3-a455-98c0b8890f782024-10-28WarningsExact identifier
application number: M013
leader AcetaminophenACETAMINOPHENCardinal Health 110, LLC. dba Leader36bdcac9-eed4-40f9-a6f2-4c1e773a6b502024-10-25WarningsExact identifier
application number: M013
GOODYS PMACETAMINOPHEN AND DIPHENHYDRAMINE CITRATEMedtech Products Inc.db5d6c2b-688e-4e88-a42d-0fa2b0d8140b2024-10-25WarningsExact identifier
application number: M013
Goodys Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.16d774cc-4247-4bf8-9b5a-c338ffebda3d2024-10-25WarningsExact identifier
application number: M013
aspirinASPIRINPUBLIX SUPER MARKETS INC9e77ab7a-07e8-42aa-e053-2995a90a0d0e2024-10-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENKroger Company5bfd9841-c781-43be-b823-d334893ae6ed2024-10-24WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENH E Badd6952e-9dd5-487c-93e6-337e9d6a48722024-10-24WarningsExact identifier
application number: M013
Dye Free Pain Reliever ChildrensACETAMINOPHENSafeway, Inc.7d55cb42-295f-473a-941d-71825b44a3c02024-10-24WarningsExact identifier
application number: M013
rapid release pain reliefACETAMINOPHENPublix Super Markets Incd0b34133-d69d-47db-bf51-be942769c6122024-10-24WarningsExact identifier
application number: M013
basic care acetaminophenACETAMINOPHENAmazon.com Services LLC00146b91-008d-4b16-95b0-6077f98821be2024-10-24WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.9a20273e-a4d1-4c38-9efb-e6347f8dc14e2024-10-24WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENMARC GLASSMAN, INC.e221905b-a795-c067-e053-2a95a90a02e72024-10-23WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMARC GLASSMAN, INC.e221bbce-83de-0f03-e053-2995a90abca52024-10-23WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENMARC GLASSMAN, INC.e231c2f6-927c-1ab0-e053-2995a90a61212024-10-23WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENMARC GLASSMAN, INC.e23703bb-6087-7985-e053-2995a90aa5ec2024-10-23WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMARC GLASSMAN, INC.e237550d-711d-5d87-e053-2995a90affce2024-10-23WarningsExact identifier
application number: M013
AspirinASPIRINHARRIS TEETERa6f15f71-1327-4b71-b9d6-e3e9f02438012024-10-22WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETER43308b23-7d4f-4e4f-a497-af71920d86aa2024-10-22WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENMARC GLASSMAN, INC.e21e821c-9694-5db0-e053-2995a90ad0342024-10-22WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN4005f8dd-3050-4590-8703-6997444e8df330
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD4005f8dd-3050-4590-8703-6997444e8df330
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY4005f8dd-3050-4590-8703-6997444e8df330

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-485-01638680485011 BOTTLE, PLASTIC in 1 CARTON (63868-485-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1992-11-172027-03-31NoNoCurrent
63868-485-02638680485021 in 1 CARTONHistorical
63868-485-24638680485241 BOTTLE, PLASTIC in 1 CARTON (63868-485-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1992-11-172027-03-31NoNoCurrent
63868-485-50638680485501 BOTTLE, PLASTIC in 1 CARTON (63868-485-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1992-11-172027-03-31NoNoCurrent