FDA.reportPublic FDA data

Tension Headache

Product NDC
11822-0428
11-digit product format
118220428
Labeler code
11822
Product ID
11822-0428_e34ac10c-7627-4cb8-925a-3a592b072290
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
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

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal 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
307686Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
093a7c26-f2b1-4416-b193-81133d247d2eAvailable 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
11822-0428-2Tension HeadacheAspirin-Free100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10015
11822-0428-2Tension HeadacheAspirin-Free1 in 1 CARTONTABLET, FILM COATED115

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
CAFFEINEACTIVE INGREDIENT3G6A5W338ETENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
CAFFEINEACTIVE MOIETY3G6A5W338ETENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KTENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ETENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0428TENSION HEADACHE ASPIRIN-FREE (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [RITE AID CORPORATION]14Current NDC, Legacy NDC, 2 package rows20240825_093a7c26-f2b1-4416-b193-81133d247d2e.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 57 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health pain reliefACETAMINOPHENDolgencorp, LLC382fa2cc-1c39-4bee-b528-08b11ec945af2024-11-02WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENBryant Ranch Prepackf7e20527-1d4b-434c-997b-3eb8211fdaa12024-11-01WarningsExact identifier
application number: M013
Aspirin Enteric Safety CoatedASPIRINPublix Supermarkets, Inc.a661a9ed-9b31-46b1-aafb-61d1ba8a49182024-11-01WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENBryant Ranch Prepack614e69c7-d3cb-4d47-9603-c1c14b87544c2024-11-01WarningsExact identifier
application number: M013
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporationbaee03b8-fcfd-440e-90ea-1ee2a18516ef2024-11-01WarningsExact identifier
application number: M013
good neighbor pharmacy infants pain and feverACETAMINOPHENAmerisource Bergenbfb954b7-3a79-4bca-95e8-d39e1074b07f2024-11-01WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEVERACETAMINOPHEN, ASPIRIN AND CAFFEINEProficient Rx LPbf365bfc-35cc-47f9-a50b-ff2b38d7316b2024-11-01WarningsExact identifier
application number: M013
Infants Pain ReliefACETAMINOPHENPublix Super Markets Inc0bc33897-afc2-4d11-be6c-a26480f448bf2024-10-31WarningsExact identifier
application number: M013
equate infants pain and feverACETAMINOPHENWALMART INC.34b2512e-743b-45db-92cb-ea05e2f47b3d2024-10-31WarningsExact identifier
application number: M013
foster and thrive infants pain and feverACETAMINOPHENStrategic Sourcing Services LLC45770ad6-9bf7-41bd-a724-e5260cd31fa12024-10-31WarningsExact identifier
application number: M013
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLETLil' Drug Store Products, Inc.d20425a4-f074-4154-e053-2995a90ae9fd2024-10-30WarningsExact identifier
application number: M013
up and up infants acetaminophenACETAMINOPHENTarget Corporation31104956-04d7-41b5-82be-219ded5c02a92024-10-30WarningsExact identifier
application number: M013
Sunmark AspirinASPIRINStrategic Sourcing Services LLCa7139686-b351-47dc-a395-832429aaa5692024-10-30WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Pain ReliefACETAMINOPHENAmerisource Bergen5101125d-4819-4e4b-a0ee-a0ff8d5a0ab12024-10-30WarningsExact identifier
application number: M013
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN093a7c26-f2b1-4416-b193-81133d247d2e15
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD093a7c26-f2b1-4416-b193-81133d247d2e15
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY093a7c26-f2b1-4416-b193-81133d247d2e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-0428-2118220428021 BOTTLE, PLASTIC in 1 CARTON (11822-0428-2) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2007-01-170000-00-00NoNoCurrent