FDA.reportPublic FDA data

Tension Headache

Product NDC
59779-824
11-digit product format
597790824
Labeler code
59779
Product ID
59779-824_9968dd59-8bdc-4502-8c81-c879d3a00aed
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-17
Substance
ACETAMINOPHEN; CAFFEINE
Active strength
500; 65 mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59779-82459779-824-08DDiscontinued by firm2026-10-20
excluded packagepackage59779-82459779-824-12DDiscontinued by firm2026-10-20

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 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0559779-824-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-824-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2659779-824-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659779-824-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3159779-824-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159779-824-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2859779-824-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859779-824-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2159779-824-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159779-824-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1059779-824-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059779-824-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3159779-824-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159779-824-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2059779-824-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059779-824-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1059779-824-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059779-824-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0859779-824-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0359779-824-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0959779-824-12557ba5c1ecfa…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
Tension Headache
Brand name suffix
Aspirin Free
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
CAFFEINE65 mg/1

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
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
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product 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
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
59779-824-06Tension HeadacheAspirin Free200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20018
59779-824-08Tension HeadacheAspirin Free24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2418
59779-824-08Tension HeadacheAspirin Free1 in 1 CARTONTABLET, FILM COATED118
59779-824-12Tension HeadacheAspirin Free100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10018
59779-824-12Tension HeadacheAspirin Free1 in 1 CARTONTABLET, FILM COATED118
59779-824-21Tension HeadacheAspirin Free100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-824-12EA - Each59779-82418dc0a6e-ad37-474c-95ae-0fdb611954a612022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTENSION HEADACHE ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
CAFFEINEACTIVE INGREDIENT3G6A5W338ETENSION HEADACHE ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTENSION HEADACHE ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
CAFFEINEACTIVE MOIETY3G6A5W338ETENSION HEADACHE ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KTENSION HEADACHE ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TENSION HEADACHE ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTENSION HEADACHE ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTENSION HEADACHE ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
TALCINACTIVE INGREDIENT7SEV7J4R1UTENSION HEADACHE ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTENSION HEADACHE ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-824TENSION HEADACHE ASPIRIN FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [CVS PHARMACY]16Current NDC, Legacy NDC, 6 package rows20240724_45f836fd-3b48-4571-9644-957e5577f246.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 33 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGTH PAIN RELIEVERACETAMINOPHEN, ASPIRIN AND CAFFEINEGeri-Care Pharmaceutical Corpb670a898-2360-76e2-e053-2a95a90a33802025-11-17WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.ec902e52-0f48-4a61-b67d-17e1c14616192025-11-15WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.72babe91-2586-4f05-ae90-6debfd23aa5d2025-11-15WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINStrategic Sourcing Services LLC3c7883da-6f51-4716-b012-0e33d239a60e2025-11-15WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINSam's West Inc3b84746f-05ab-4f88-b9ae-efb8c5dfc2332025-11-15WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENWalgreen Companya482e715-bec0-44a4-bb0e-ea5f5fda558e2025-11-15WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf1157dbc-d86c-4554-954c-60a74674ff6b2025-11-15WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINENuCare Pharmaceuticals,Inc.437e4fd9-c7d9-77d6-e063-6294a90a22b72025-11-13WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENL. Perrigo Company7f78028a-484b-48b3-a37a-1e0b055bbefc2025-11-13WarningsExact identifier
application number: M013
OneSsip AcetaminophenACETAMINOPHENMEDWISE LIFESCIENCES INC.3f88de0f-6cf6-3580-e063-6294a90abcb42025-11-12WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b1a31-353d-af20-e063-6294a90aa9072025-11-11WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Pain ReliefACETAMINOPHENAmerisource Bergen4b829607-f5fb-427f-83b5-5b6b9c44ebeb2025-11-11WarningsExact identifier
application number: M013
Pamprin Max Menstrual Pain ReliefACETAMINOPHEN AND ASPIRIN AND CAFFEINEFocus Consumer Healthcare, LLC5bd4b935-f003-7df8-e053-2a91aa0a5d792025-11-10WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp61e50135-a7c2-4a86-8a1a-d47b41d3f9d12025-11-07WarningsExact identifier
application number: M013
Childrens ChewablesACETAMINOPHENStrategic Sourcing Services LLCaf2cbbaf-9b73-440a-bc88-a790cafccc6b2025-11-07WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINL.N.K. International, Inc.39e142a7-8590-4e1e-8319-6904fb57cc8a2025-11-06WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC42321456-d7dd-3b51-e063-6394a90ac2922025-11-05WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENFamily Dollar Services Inc76058eb3-2d3f-4414-87df-7167cd27d26b2025-11-05WarningsExact identifier
application number: M013
Children Pain and Fever ReliverACETAMINOPHENTarget Corporation1116f808-f61e-47ec-b0d0-d4be5aa905be2025-11-04WarningsExact identifier
application number: M013
Pain Reliever Dye FreeACETAMINOPHENTIME CAP LABORATORIES, INC.42c4f0b2-6483-0f3c-e063-6294a90a140f2025-11-04WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN45f836fd-3b48-4571-9644-957e5577f24618
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD45f836fd-3b48-4571-9644-957e5577f24618
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY45f836fd-3b48-4571-9644-957e5577f24618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59779-824-0659779082406200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59779-824-06) 2007-01-170000-00-00NoNoCurrent
59779-824-08597790824081 BOTTLE, PLASTIC in 1 CARTON (59779-824-08) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2007-01-170000-00-00NoNoCurrent
59779-824-1259779082412100 in 1 BOTTLE, PLASTICHistorical
59779-824-2159779082421100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59779-824-21) 2007-01-170000-00-00NoNoCurrent