FDA.reportPublic FDA data

Tension Headache Relief

Product NDC
69168-029
11-digit product format
691680029
Labeler code
69168
Product ID
69168-029_5fa5b219-61a3-4b4b-bc29-a3982701ebce
Type
HUMAN OTC DRUG
Nonproprietary name
Tension Headache Relief
Dosage form
CAPSULE
Route
ORAL
Labeler
Allegiant Health
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-26
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tension Headache Relief
Listing expiration
2026-12-31

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
410226Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b431a1a3-39c4-4d6c-afdc-c8b017ad89daAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-029-24Tension Headache Relief24 in 1 BOTTLECAPSULE2410
69168-029-26Tension Headache Relief20 in 1 BOTTLECAPSULE2010
69168-029-37Tension Headache Relief1 in 1 CARTONCAPSULE110
69168-029-37Tension Headache Relief16 in 1 BOTTLECAPSULE1610
69168-029-50Tension Headache Relief50 in 1 BOTTLECAPSULE5010
69168-029-98Tension Headache Relief200 in 1 BOTTLECAPSULE20010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
CAFFEINEACTIVE INGREDIENT3G6A5W338ETENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
CAFFEINEACTIVE MOIETY3G6A5W338ETENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KTENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-029TENSION HEADACHE RELIEF CAPSULE [ALLEGIANT HEALTH]10Current NDC, Legacy NDC, 6 package rows20231109_b431a1a3-39c4-4d6c-afdc-c8b017ad89da.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 1 of 85 · 1,692 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
application number: M013
equate aspirinASPIRINWal-Mart Stores Incea3f8eed-7b70-4156-9586-125d27bf29a82026-08-19WarningsExact identifier
application number: M013
CARDIASPIRIN PROTECTASPIRINOPMX LLC03774690-662b-1c30-e063-6294a90a34882026-08-19WarningsExact identifier
application number: M013
aspirin chewable, low doseASPIRINUnited Natural Foods, Inc. dba UNFI6a6ac7fe-91a4-4b55-979a-b53b51505d8b2026-08-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
application number: M013
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact identifier
application number: M013
Headache Formula Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEARMY AND AIR FORCE EXCHANGE SERVICEee8d0961-7572-471f-8c96-b4c0bd354de22026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRugby Laboratories76f10ee2-1d6a-097c-e053-2991aa0af5262026-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMajor Pharmaceuticals780aad35-d0f1-44b1-e053-2991aa0af9a72026-08-18WarningsExact identifier
application number: M013
CHILDRENS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC5eacbc4f-d20a-4c22-9680-4a648e24de432026-08-18WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENWinCo Foods, LLC15921c3f-e8d4-4794-983f-63bb926f6f862026-08-15WarningsExact identifier
application number: M013
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
application number: M013
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECVS Pharmacy31ccc867-ca83-70a9-f3d5-5644030047b82026-08-13WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
410226acetaminophen 500 MG / caffeine 65 MG Oral CapsulePSNb431a1a3-39c4-4d6c-afdc-c8b017ad89da10
410226acetaminophen 500 MG / caffeine 65 MG Oral CapsuleSCDb431a1a3-39c4-4d6c-afdc-c8b017ad89da10
410226APAP 500 MG / Caffeine 65 MG Oral CapsuleSYb431a1a3-39c4-4d6c-afdc-c8b017ad89da10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-029-246916800292424 CAPSULE in 1 BOTTLE (69168-029-24) 24 capsule2014-11-260000-00-00NoNoCurrent
69168-029-266916800292620 CAPSULE in 1 BOTTLE (69168-029-26) 20 capsule2020-01-200000-00-00NoNoCurrent
69168-029-37691680029371 BOTTLE in 1 CARTON (69168-029-37) / 16 CAPSULE in 1 BOTTLE1 bottle2021-12-150000-00-00NoNoCurrent
69168-029-506916800295050 CAPSULE in 1 BOTTLE (69168-029-50) 50 capsule2022-06-130000-00-00NoNoCurrent
69168-029-9869168002998200 CAPSULE in 1 BOTTLE (69168-029-98) 200 capsule2014-11-260000-00-00NoNoCurrent